<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04458909</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2020-04581</org_study_id>
    <secondary_id>NCI-2020-04581</secondary_id>
    <secondary_id>NRG-HN007</secondary_id>
    <secondary_id>NRG-HN007</secondary_id>
    <secondary_id>U10CA180868</secondary_id>
    <nct_id>NCT04458909</nct_id>
  </id_info>
  <brief_title>Testing the Addition of an Anti-cancer Immune Therapy Drug (Nivolumab) to the Usual Chemotherapy Treatment (Cisplatin or Carboplatin With Gemcitabine) for Recurrent or Metastatic Nasopharyngeal Cancer</brief_title>
  <official_title>An Open-Label, Phase III Study of Platinum-Gemcitabine With or Without Nivolumab in the First-Line Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NRG Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Cancer Institute (NCI)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial compares the effect of adding nivolumab to the usual chemotherapy&#xD;
      (cisplatin or carboplatin with gemcitabine) versus standard chemotherapy alone in treating&#xD;
      patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places&#xD;
      in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may&#xD;
      help the body's immune system attack the cancer, and may interfere with the ability of tumor&#xD;
      cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and&#xD;
      gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the&#xD;
      cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab&#xD;
      with the usual chemotherapy may work better than the standard chemotherapy alone in treating&#xD;
      patients with nasopharyngeal cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment improves&#xD;
      overall survival (OS) for patients with recurrent and/or metastatic nasopharyngeal carcinoma&#xD;
      (NPC).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To compare patterns of failure (local-regional relapse and distant metastasis) between&#xD;
      treatment arms.&#xD;
&#xD;
      II. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment improves&#xD;
      the objective tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST)&#xD;
      1.1.&#xD;
&#xD;
      III. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment&#xD;
      improves progression free survival (PFS) for patients with recurrent and/or metastatic NPC.&#xD;
&#xD;
      IV. To evaluate the toxicity based on the Common Terminology Criteria for Adverse Events&#xD;
      (CTCAE) version (v)5.0.&#xD;
&#xD;
      V. To characterize patient-reported symptomatic toxicities measured by Patient-Reported&#xD;
      Outcomes (PRO)-CTCAE.&#xD;
&#xD;
      VI. To assess the quality of life (QOL), as measured by the European Organization for&#xD;
      Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30,&#xD;
      between the two arms (primary PRO).&#xD;
&#xD;
      VII. To assess fatigue, as measured by Multidimensional Fatigue Inventory (MFI-20), between&#xD;
      the two arms (secondary PRO).&#xD;
&#xD;
      VIII. To determine if a subset of patients based on an optimal cutoff point of PD-L1 Combined&#xD;
      Positive Score (CPS)/Tumor Proportion Score (TPS) is more likely to benefit in terms of PFS&#xD;
      from adding nivolumab to platinum-gemcitabine as first-line treatment.&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I. To determine if a subset of patients based on an optimal cutoff point of PD-L1 CPS/TPS is&#xD;
      more likely to benefit in terms of overall survival (OS) from adding nivolumab to&#xD;
      platinum-gemcitabine as first-line treatment.&#xD;
&#xD;
      II. To determine changes in QOL as measured by EORTC QLQ-C30 and in fatigue as measured by&#xD;
      MFI-20, between and within arms over time (exploratory PRO).&#xD;
&#xD;
      III. To collect blood and tissue specimens for future translational research.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1, gemcitabine IV&#xD;
      over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over&#xD;
      30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of&#xD;
      disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab&#xD;
      IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the&#xD;
      absence of disease progression or unacceptable toxicity.&#xD;
&#xD;
      ARM II: Patients receive gemcitabine and cisplatin or carboplatin as in Arm I.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 4 months for 2 years,&#xD;
      every 6 months for 3 years, and then annually.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 9, 2020</start_date>
  <completion_date type="Anticipated">May 9, 2028</completion_date>
  <primary_completion_date type="Anticipated">May 9, 2028</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From randomization until death due to any cause or last follow-up. Analysis occurs after 200 deaths have been reported, assessed up to 8 years</time_frame>
    <description>Overall survival rates for both treatment arms will be estimated using the Kaplan-Meier method. The comparison of OS distributions between treatment arms will be done using a log-rank test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Locoregional failure</measure>
    <time_frame>From randomization until local or regional progression, death, or last follow-up, assessed up to 8 years</time_frame>
    <description>Rates estimated by cumulative incidence method and arms compared by cause-specific log-rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distant metastases</measure>
    <time_frame>From randomization until distant progression, death, or last follow-up, assessed up to 8 years</time_frame>
    <description>Rates estimated by cumulative incidence method and arms compared by cause-specific log-rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>From randomization until progression or death due to any cause, or last follow-up, assessed up to 8 years</time_frame>
    <description>Rates estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor response</measure>
    <time_frame>From randomization to last follow-up, assessed up to 8 years</time_frame>
    <description>Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1. The Objective Response Rate (ORR), defined as the proportion of confirmed complete and partial response, will be calculated with their respective 95% confidence intervals (CI). An estimate of the difference in ORR between the experimental and control arms along with the 95% CI, will also be provided. The between-arm difference in ORR will be assessed using a chi-square test for proportions based on normal approximation. The confidence intervals will be also based on a normal approximation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events (AEs)</measure>
    <time_frame>From start of treatment to last follow-up, assessed up to 8 years</time_frame>
    <description>Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Counts of all AEs by grade will be provided by the treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient's treatment arm. The number of patients with at least 1 grade 3 or higher AE will be compared between the treatment arms. All comparisons will be tested using a chi-Square test, or Fisher's exact test if cell frequencies are &lt; 5, with a significance level of 0.05. Toxicity analyses will be based on an as-treated population, including all patients who received at least one dose of the assigned trial treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-reported symptomatic toxicities</measure>
    <time_frame>From randomization to 2 years</time_frame>
    <description>Will be assessed by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). The proportion of patients with scores &gt;= 1 and &gt;= 3 will be compared between groups using a Chi-square test, or Fisher's exact test if cell frequencies are &lt; 5, using a significance level of 0.05. Analysis of changes in patient reported outcomes over time will be analyzed by fitting generalized estimating equation (GEE) models using a logit link (dichotomizing the symptom scores as 0 versus [vs.] &gt; 1 and 0-2 vs. 3-4) with the time of assessment, treatment arm, and treatment-by-time interaction terms in the model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>From randomization to 2 years</time_frame>
    <description>Will be assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>From randomization to 2 years</time_frame>
    <description>Will be assessed by Multidimensional Fatigue Inventory (MFI-20).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival by PD-L1 Combined Positive Score (CPS)/Tumor Proportion Score (TPS) cut-off</measure>
    <time_frame>From randomization until progression or death due to any cause, or last follow-up, assessed up to 8 years</time_frame>
    <description>Will be assessed based on PD-L1 CPS/TPS cut-off.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Overall survival by PD-L1 CPS/TPS cut-off</measure>
    <time_frame>From randomization until death due to any cause or last follow-up, assessed up to 8 years</time_frame>
    <description>Will be assessed based on PD-L1 CPS/TPS cut-off.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>From randomization to 2 years</time_frame>
    <description>Will be measured by EORTC QLQ-C30 between and within arms over time.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in fatigue</measure>
    <time_frame>From randomization to 2 years</time_frame>
    <description>Will be measured by MFI-20 between and within arms over time.</description>
  </other_outcome>
  <other_outcome>
    <measure>Translational research studies</measure>
    <time_frame>From randomization to last follow-up, assessed up to 8 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">316</enrollment>
  <condition>Metastatic Nasopharyngeal Carcinoma</condition>
  <condition>Metastatic Nasopharyngeal Keratinizing Squamous Cell Carcinoma</condition>
  <condition>Metastatic Nasopharyngeal Nonkeratinizing Carcinoma</condition>
  <condition>Metastatic Nasopharyngeal Undifferentiated Carcinoma</condition>
  <condition>Nasopharyngeal Nonkeratinizing Carcinoma</condition>
  <condition>Recurrent Nasopharyngeal Carcinoma</condition>
  <condition>Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma</condition>
  <condition>Recurrent Nasopharyngeal Undifferentiated Carcinoma</condition>
  <condition>Stage IV Nasopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage IVA Nasopharyngeal Carcinoma AJCC v8</condition>
  <condition>Stage IVB Nasopharyngeal Carcinoma AJCC v8</condition>
  <arm_group>
    <arm_group_label>Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive gemcitabine and cisplatin or carboplatin as in Arm I.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <arm_group_label>Arm II (gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <other_name>Blastocarb</other_name>
    <other_name>Carboplat</other_name>
    <other_name>Carboplatin Hexal</other_name>
    <other_name>Carboplatino</other_name>
    <other_name>Carboplatinum</other_name>
    <other_name>Carbosin</other_name>
    <other_name>Carbosol</other_name>
    <other_name>Carbotec</other_name>
    <other_name>CBDCA</other_name>
    <other_name>Displata</other_name>
    <other_name>Ercar</other_name>
    <other_name>JM-8</other_name>
    <other_name>JM8</other_name>
    <other_name>Nealorin</other_name>
    <other_name>Novoplatinum</other_name>
    <other_name>Paraplatin</other_name>
    <other_name>Paraplatin AQ</other_name>
    <other_name>Paraplatine</other_name>
    <other_name>Platinwas</other_name>
    <other_name>Ribocarbo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <arm_group_label>Arm II (gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <other_name>Abiplatin</other_name>
    <other_name>Blastolem</other_name>
    <other_name>Briplatin</other_name>
    <other_name>CDDP</other_name>
    <other_name>Cis-diammine-dichloroplatinum</other_name>
    <other_name>Cis-diamminedichloridoplatinum</other_name>
    <other_name>Cis-diamminedichloro Platinum (II)</other_name>
    <other_name>Cis-diamminedichloroplatinum</other_name>
    <other_name>Cis-dichloroammine Platinum (II)</other_name>
    <other_name>Cis-platinous Diamine Dichloride</other_name>
    <other_name>Cis-platinum</other_name>
    <other_name>Cis-platinum II</other_name>
    <other_name>Cis-platinum II Diamine Dichloride</other_name>
    <other_name>Cismaplat</other_name>
    <other_name>Cisplatina</other_name>
    <other_name>Cisplatinum</other_name>
    <other_name>Cisplatyl</other_name>
    <other_name>Citoplatino</other_name>
    <other_name>Citosin</other_name>
    <other_name>Cysplatyna</other_name>
    <other_name>DDP</other_name>
    <other_name>Lederplatin</other_name>
    <other_name>Metaplatin</other_name>
    <other_name>Neoplatin</other_name>
    <other_name>Peyrone's Chloride</other_name>
    <other_name>Peyrone's Salt</other_name>
    <other_name>Placis</other_name>
    <other_name>Plastistil</other_name>
    <other_name>Platamine</other_name>
    <other_name>Platiblastin</other_name>
    <other_name>Platiblastin-S</other_name>
    <other_name>Platinex</other_name>
    <other_name>Platinol</other_name>
    <other_name>Platinol- AQ</other_name>
    <other_name>Platinol-AQ</other_name>
    <other_name>Platinol-AQ VHA Plus</other_name>
    <other_name>Platinoxan</other_name>
    <other_name>Platinum</other_name>
    <other_name>Platinum Diamminodichloride</other_name>
    <other_name>Platiran</other_name>
    <other_name>Platistin</other_name>
    <other_name>Platosin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <arm_group_label>Arm II (gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <other_name>dFdC</other_name>
    <other_name>dFdCyd</other_name>
    <other_name>Difluorodeoxycytidine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <other_name>ABP 206</other_name>
    <other_name>BMS-936558</other_name>
    <other_name>CMAB819</other_name>
    <other_name>MDX-1106</other_name>
    <other_name>NIVO</other_name>
    <other_name>Nivolumab Biosimilar ABP 206</other_name>
    <other_name>Nivolumab Biosimilar CMAB819</other_name>
    <other_name>ONO-4538</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)</arm_group_label>
    <arm_group_label>Arm II (gemcitabine, cisplatin, carboplatin)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pathologically (histologically or cytologically) proven diagnosis of NPC that has&#xD;
             recurred at locoregional and/or distant sites. For locoregional recurrence, the&#xD;
             disease must not be amenable to potentially curative surgery or re-irradiation. The&#xD;
             following histological types are accepted: (a) Keratinizing - squamous cell carcinoma;&#xD;
             (b) Non-keratinizing - undifferentiated or poorly differentiated&#xD;
&#xD;
          -  Measurable disease by the RECIST 1.1 criteria. Lesion(s) that have been irradiated&#xD;
             previously can be counted as measurable as long as radiological progression has been&#xD;
             demonstrated prior to enrollment&#xD;
&#xD;
          -  History/physical examination by a medical oncologist or clinical oncologist within 14&#xD;
             days prior to registration&#xD;
&#xD;
          -  Zubrod/Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 14&#xD;
             days prior to registration&#xD;
&#xD;
          -  Contrast enhanced magnetic resonance imaging (MRI) or computed tomography (CT) of the&#xD;
             nasopharynx and neck within 30 days prior to registration&#xD;
&#xD;
          -  Contrast enhanced CT scan of the chest, abdomen, and pelvis within 30 days prior to&#xD;
             registration&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1500 cells/mm^3 (within 14 days prior to&#xD;
             registration)&#xD;
&#xD;
          -  Platelets &gt;= 100,000 cells/mm^3 (within 14 days prior to registration)&#xD;
&#xD;
          -  Hemoglobin &gt;= 9.0 g/dL (transfusion is accepted. Erythropoietin dependency not&#xD;
             accepted) (within 14 days prior to registration)&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x upper limit of normal (ULN) OR direct bilirubin =&lt; ULN for&#xD;
             patients with total bilirubin levels &gt; 1.5 x ULN. Patients with known Gilbert's&#xD;
             syndrome are not excluded (within 14 days prior to registration)&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =&lt; 2.5 x&#xD;
             ULN (=&lt; 3 x ULN for patients with liver metastases) (within 14 days prior to&#xD;
             registration)&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 x ULN OR calculated creatinine clearance (CrCl) based on&#xD;
             Cockcroft-Gault equation &gt;= 30 mL/min for patients with serum creatinine levels &gt; 1.5&#xD;
             x ULN. In this protocol, cisplatin or carboplatin may be used at the discretion of the&#xD;
             investigator - except for patients with CrCl between 30-50 mL/min, for whom&#xD;
             carboplatin should be used instead of cisplatin (within 14 days prior to registration)&#xD;
&#xD;
          -  For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral&#xD;
             load must be undetectable, and patients must be receiving anti-viral therapy at&#xD;
             enrollment. Patients must agree to continue anti-viral therapy throughout the study&#xD;
             period as directed by their treating physicians&#xD;
&#xD;
               -  Known positive test for hepatitis B virus surface antigen (HBsAg) indicating&#xD;
                  acute or chronic infection would make the patient ineligible unless the viral&#xD;
                  load becomes undetectable on anti-viral therapy&#xD;
&#xD;
               -  Patients who are immune to hepatitis B (anti-Hepatitis B surface antibody&#xD;
                  positive) are eligible (i.e., patients immunized against hepatitis B)&#xD;
&#xD;
               -  In some centers, hepatitis B core antibody (anti-HBc) is done routinely before&#xD;
                  chemotherapy for some cancer patients. This is because patients who are&#xD;
                  HBsAg-negative but positive for anti-HBc should have undetectable HBV viral load&#xD;
                  at enrollment and receive prophylactic anti-viral therapy throughout the study&#xD;
                  (American Society of Clinical Oncology 2015 guideline, Hwang 2015). In this&#xD;
                  protocol, anti-HBc should be performed based on institutional standards&#xD;
&#xD;
          -  Patients with a history of hepatitis C virus (HCV) infection must have been treated&#xD;
             and cured. For patients with HCV infection who are currently on treatment they are&#xD;
             eligible if they have an undetectable HCV viral load&#xD;
&#xD;
               -  Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA)&#xD;
                  indicating acute or chronic infection would make the patient ineligible unless&#xD;
                  the viral load becomes undetectable on suppressive therapy&#xD;
&#xD;
          -  For women of childbearing potential (WOCBP), negative serum or urine pregnancy test&#xD;
             within 14 days prior to registration. For WOCBP randomized to Arm 1, an additional&#xD;
             negative serum or urine pregnancy is required within 24 hours prior to starting&#xD;
             nivolumab treatment&#xD;
&#xD;
               -  Women of childbearing potential (WOCBP) is defined as any female who has&#xD;
                  experienced menarche and who has not undergone surgical sterilization&#xD;
                  (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause&#xD;
                  is defined clinically as 12 months of amenorrhea in a woman over 45 in the&#xD;
                  absence of other biological or physiological causes&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP&#xD;
             must be willing to use an adequate method of contraception. Women must use an&#xD;
             effective oral contraception and the male partner must use condom) during and after&#xD;
             treatment&#xD;
&#xD;
          -  The patient or a legally authorized representative must provide written informed&#xD;
             consent prior to study entry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with another invasive malignancy (except non-melanomatous skin cancer)&#xD;
             unless disease free for more than 3 years. Note: Patients with basal cell carcinoma of&#xD;
             the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast&#xD;
             carcinoma, cervical cancer in situ) who have undergone potentially curative therapy&#xD;
             are not excluded&#xD;
&#xD;
          -  Any prior systemic anti-cancer agents (including chemotherapy and investigational&#xD;
             agents) for the purpose of treating locoregional and/or distant recurrence of NPC&#xD;
&#xD;
          -  Patients who have received neoadjuvant (induction) and/or adjuvant chemotherapy for&#xD;
             primary NPC with chemotherapy (any drug regimens including those containing platinum&#xD;
             and/or gemcitabine) at or within 6 months prior to registration are excluded (counting&#xD;
             from the last day of the chemotherapy for the primary NPC, prior to enrolling into the&#xD;
             current study). The following subgroups of patients are NOT excluded:&#xD;
&#xD;
               -  Patients who have received neoadjuvant (induction) and/or adjuvant chemotherapy&#xD;
                  for primary (non-metastatic/non-recurrent) NPC more than 6 months prior to&#xD;
                  registration, counting from the last day of the chemoradiotherapy for the primary&#xD;
                  NPC, prior to enrolling into the current study&#xD;
&#xD;
               -  For prior RT with radical intent: Patients who have prior radiotherapy (RT) to&#xD;
                  the primary and locoregional disease (i.e. non-recurrent disease) with or without&#xD;
                  concurrent cisplatin or carboplatin monotherapy are not excluded as long as they&#xD;
                  have not received any neoadjuvant/adjuvant chemotherapy within 6 months prior to&#xD;
                  registration (counting from the last day of the chemotherapy), and that the last&#xD;
                  RT fraction (with radical intent) has been given more than 3 months prior to&#xD;
                  registration&#xD;
&#xD;
               -  For RT with palliative intent: Prior radiotherapy (RT) at or within 30 days prior&#xD;
                  to registration, this includes RT given with palliative intent (with or without&#xD;
                  concurrent cisplatin or carboplatin alone) to recurrent/ metastatic sites in&#xD;
                  patients with recurrent/metastatic NPC. The re-irradiated sites must not be the&#xD;
                  only sites of measurable recurrent disease&#xD;
&#xD;
               -  Prior chemotherapy for cancers other than NPC is allowed as long as the last&#xD;
                  course of chemotherapy was administered more than 3 years prior to registration&#xD;
                  and the patient has remained disease-free for more than 3 years&#xD;
&#xD;
          -  Prior therapy for any indication, with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent&#xD;
             or with an agent directed to another stimulatory or co-inhibitory T-cell receptor&#xD;
             (e.g. CTLA-4, OX-40, CD137)&#xD;
&#xD;
          -  History of severe (grade 3-4) hypersensitivity reaction to any monoclonal antibody&#xD;
             including nivolumab and/or any of its excipients&#xD;
&#xD;
          -  Severe, active co-morbidity defined as follows:&#xD;
&#xD;
               -  Unstable angina and/or congestive heart failure requiring hospitalization within&#xD;
                  the last 6 months&#xD;
&#xD;
               -  Myocardial infarction within the last 6 months&#xD;
&#xD;
               -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time&#xD;
                  of registration&#xD;
&#xD;
               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness&#xD;
                  requiring hospitalization or precluding study therapy within 30 days of&#xD;
                  registration&#xD;
&#xD;
               -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects&#xD;
&#xD;
               -  History of (non-infectious) pneumonitis that required steroids or has current&#xD;
                  pneumonitis requiring steroids and/or immunosuppressive therapy&#xD;
&#xD;
               -  History of active TB (Bacillus tuberculosis, not known to be multi-drug&#xD;
                  resistant) as defined by the need to receive systemic treatment within the last 2&#xD;
                  years or any known history of multi-drug resistant TB. Note: Patients who had a&#xD;
                  distant history of treated TB (not known to be multi-drug resistant) at 5 or more&#xD;
                  years from enrollment and have no current symptoms suggestive of active TB, are&#xD;
                  not excluded from this study. Note: Testing for prior exposure to TB is not&#xD;
                  required in this study since TB is endemic in parts of Asia&#xD;
&#xD;
               -  Prior solid organ transplant or bone marrow transplant&#xD;
&#xD;
               -  History of active primary immunodeficiency including, but not limited to acquired&#xD;
                  immune deficiency syndrome (AIDS) based upon current Centers for Disease Control&#xD;
                  and Prevention (CDC) definition; Note: Human immunodeficient virus (HIV) testing&#xD;
                  is not required for entry into this protocol. The need to exclude patients with&#xD;
                  AIDS from this protocol is necessary because the treatment involved in this&#xD;
                  protocol may be immunosuppressive&#xD;
&#xD;
               -  Condition requiring systemic treatment with either corticosteroids (&gt; 10 mg daily&#xD;
                  prednisone or equivalents) or other immunosuppressive medications within 14 days&#xD;
                  of registration. Inhaled or topical steroids and adrenal replacement doses &lt; 10&#xD;
                  mg daily prednisone equivalents are permitted in the absence of active autoimmune&#xD;
                  disease. Steroid premedication for the prophylaxis of CT contrast-related&#xD;
                  allergies is allowed. The use of dexamethasone as an anti-emetic premedication&#xD;
                  prior to chemotherapy is also allowed&#xD;
&#xD;
               -  Active autoimmune disease requiring systemic treatment (i.e. disease modifying&#xD;
                  agents, corticosteroids, or immunosuppressive drugs) within the past 2 years.&#xD;
                  These include but are not limited to patients with a history of immune-related&#xD;
                  neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy,&#xD;
                  Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as&#xD;
                  systemic lupus erythematosus (SLE), rheumatoid arthritis, connective tissue&#xD;
                  diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative&#xD;
                  colitis, hepatitis; and patients with a history of toxic epidermal necrolysis&#xD;
                  (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded&#xD;
                  because of the risk of recurrence or exacerbation of disease&#xD;
&#xD;
               -  Note: Patients are permitted to enroll if they have vitiligo; type I diabetes&#xD;
                  mellitus; hypothyroidism, pituitary or adrenal insufficiency requiring only&#xD;
                  hormone replacement; psoriasis not requiring systemic treatment, or conditions&#xD;
                  not expected to recur in the absence of an external trigger (precipitating event)&#xD;
&#xD;
          -  Patients who are pregnant or breastfeeding and unwilling to discontinue breastfeeding&#xD;
&#xD;
          -  Known history of grade 3-4 allergic reaction and/or hepatic toxicity to cisplatin,&#xD;
             carboplatin, or gemcitabine&#xD;
&#xD;
               -  NOTE: For patients with known history of grade 3-4 renal toxicity to cisplatin or&#xD;
                  known history of clinically significant hearing loss (grade 2 or above)&#xD;
                  attributed to cisplatin, or other intolerances to cisplatin that are of clinical&#xD;
                  significance, carboplatin can be used in this study and therefore these patients&#xD;
                  are NOT excluded from enrollment&#xD;
&#xD;
          -  Known central nervous system (CNS) metastases and/or carcinomatous meningitis.&#xD;
             Patients with base of skull involvement by NPC are not excluded unless their disease&#xD;
             is directly invading the brain parenchyma and is associated with clinical symptoms&#xD;
             (headaches, nausea and vomiting, neurological abnormalities on physical examination)&#xD;
             and/or cerebral edema on radiological imaging&#xD;
&#xD;
          -  Patients who have received a live vaccine within 30 days prior to the first dose of&#xD;
             study treatment. Examples of live vaccines include, but are not limited to, the&#xD;
             following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, Bacillus&#xD;
             Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection&#xD;
             are generally killed virus vaccines and are allowed; however, intranasal influenza&#xD;
             vaccines (e.g., FluMist) are live attenuated vaccines and are not allowed&#xD;
&#xD;
          -  History or current evidence of any condition, therapy, or laboratory abnormality that&#xD;
             might confound the results of the study, interfere with the subject's participation&#xD;
             for the full duration of the study, or is not in the best interest of the subject to&#xD;
             participate, in the opinion of the treating investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brigette B Ma</last_name>
    <role>Principal Investigator</role>
    <affiliation>NRG Oncology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham Cancer Center</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anchorage Associates in Radiation Medicine</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>98508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anchorage Radiation Therapy Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Breast Care and Surgery LLC</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Oncology and Hematology LLC</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alaska Women's Cancer Care</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anchorage Oncology Centre</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Katmai Oncology Group</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Alaska Medical Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center at Saint Joseph's</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Fort Smith</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Saint Vincent Cancer Center Hot Springs</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Hope Medical Oncology - Arroyo Grande</name>
      <address>
        <city>Arroyo Grande</city>
        <state>California</state>
        <zip>93420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Saint Joseph Medical Center/Disney Family Cancer Center</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care-Dublin</name>
      <address>
        <city>Dublin</city>
        <state>California</state>
        <zip>94568</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Breast Surgeons Inc</name>
      <address>
        <city>Emeryville</city>
        <state>California</state>
        <zip>94608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care Partners in Cancer Care</name>
      <address>
        <city>Emeryville</city>
        <state>California</state>
        <zip>94608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Contra Costa Regional Medical Center</name>
      <address>
        <city>Martinez</city>
        <state>California</state>
        <zip>94553-3156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta Bates Summit Medical Center - Summit Campus</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Tumor Institute</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Cancer Institute Palo Alto</name>
      <address>
        <city>Palo Alto</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Central Coast Health Center-San Luis Obispo</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Hope Medical Oncology - Santa Maria</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93444</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Epic Care Cyberknife Center</name>
      <address>
        <city>Walnut Creek</city>
        <state>California</state>
        <zip>94597</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penrose-Saint Francis Healthcare</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Penrose</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Porter Adventist Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Durango</city>
        <state>Colorado</state>
        <zip>81301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Oncology PC</name>
      <address>
        <city>Durango</city>
        <state>Colorado</state>
        <zip>81301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Anthony Hospital</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Littleton Adventist Hospital</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longmont United Hospital</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Longmont</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parker Adventist Hospital</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary Corwin Medical Center</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Holy Cross Hospital</name>
      <address>
        <city>Fort Lauderdale</city>
        <state>Florida</state>
        <zip>33308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Regional Hospital/Joe DiMaggio Children's Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224-9980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital West</name>
      <address>
        <city>Pembroke Pines</city>
        <state>Florida</state>
        <zip>33028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care - Westridge</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pali Momi Medical Center</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Cancer Center - Pearlridge</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Center of Hawaii-Pali Momi</name>
      <address>
        <city>'Aiea</city>
        <state>Hawaii</state>
        <zip>96701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hawaii Cancer Care Inc - Waterfront Plaza</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Cancer Cenrer - POB I</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Straub Clinic and Hospital</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Hawaii Cancer Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kuakini Medical Center</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Cancer Center - Kuakini</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Center of Hawaii-Liliha</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kapiolani Medical Center for Women and Children</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96826</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wilcox Memorial Hospital and Kauai Medical Clinic</name>
      <address>
        <city>Lihue</city>
        <state>Hawaii</state>
        <zip>96766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Caldwell</name>
      <address>
        <city>Caldwell</city>
        <state>Idaho</state>
        <zip>83605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Health - Coeur d'Alene</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Walter Knox Memorial Hospital</name>
      <address>
        <city>Emmett</city>
        <state>Idaho</state>
        <zip>83617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Fruitland</name>
      <address>
        <city>Fruitland</city>
        <state>Idaho</state>
        <zip>83619</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Urologic Institute-Meridian</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Meridian</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Nampa</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Nampa</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83687</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Clinic Cancer Services - Post Falls</name>
      <address>
        <city>Post Falls</city>
        <state>Idaho</state>
        <zip>83854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Cancer Clinic</name>
      <address>
        <city>Sandpoint</city>
        <state>Idaho</state>
        <zip>83864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Twin Falls</name>
      <address>
        <city>Twin Falls</city>
        <state>Idaho</state>
        <zip>83301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Anthony's Health</name>
      <address>
        <city>Alton</city>
        <state>Illinois</state>
        <zip>62002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush - Copley Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Bloomington</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Canton</name>
      <address>
        <city>Canton</city>
        <state>Illinois</state>
        <zip>61520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital of Carbondale</name>
      <address>
        <city>Carbondale</city>
        <state>Illinois</state>
        <zip>62902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIH Cancer Institute</name>
      <address>
        <city>Carterville</city>
        <state>Illinois</state>
        <zip>62918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Carthage</name>
      <address>
        <city>Carthage</city>
        <state>Illinois</state>
        <zip>62321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralia Oncology Clinic</name>
      <address>
        <city>Centralia</city>
        <state>Illinois</state>
        <zip>62801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle at The Riverfront</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Specialists of Illinois - Decatur</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Dixon</name>
      <address>
        <city>Dixon</city>
        <state>Illinois</state>
        <zip>61021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Effingham</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crossroads Cancer Center</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Eureka</name>
      <address>
        <city>Eureka</city>
        <state>Illinois</state>
        <zip>61530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Galesburg</name>
      <address>
        <city>Galesburg</city>
        <state>Illinois</state>
        <zip>61401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Illinois Cancer Treatment Center</name>
      <address>
        <city>Galesburg</city>
        <state>Illinois</state>
        <zip>61401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Kewanee Clinic</name>
      <address>
        <city>Kewanee</city>
        <state>Illinois</state>
        <zip>61443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Macomb</name>
      <address>
        <city>Macomb</city>
        <state>Illinois</state>
        <zip>61455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Mattoon/Charleston</name>
      <address>
        <city>Mattoon</city>
        <state>Illinois</state>
        <zip>61938</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Regional Health Center</name>
      <address>
        <city>Mount Vernon</city>
        <state>Illinois</state>
        <zip>62864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Center of O'Fallon</name>
      <address>
        <city>O'Fallon</city>
        <state>Illinois</state>
        <zip>62269</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Ottawa Clinic</name>
      <address>
        <city>Ottawa</city>
        <state>Illinois</state>
        <zip>61350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Pekin</name>
      <address>
        <city>Pekin</city>
        <state>Illinois</state>
        <zip>61554</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peoria</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Medical Center of Illinois</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peru</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Radiation Oncology</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Princeton</name>
      <address>
        <city>Princeton</city>
        <state>Illinois</state>
        <zip>61356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield Clinic</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush-Copley Healthcare Center</name>
      <address>
        <city>Yorkville</city>
        <state>Illinois</state>
        <zip>60560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reid Health</name>
      <address>
        <city>Richmond</city>
        <state>Indiana</state>
        <zip>47374</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Greeley Medical Center</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Ames</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Boone</name>
      <address>
        <city>Boone</city>
        <state>Iowa</state>
        <zip>50036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Anthony Regional Hospital</name>
      <address>
        <city>Carroll</city>
        <state>Iowa</state>
        <zip>51401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology and Hematology Associates-West Des Moines</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center-West Lakes</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Mercy Hospital</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Regional Medical Center</name>
      <address>
        <city>Creston</city>
        <state>Iowa</state>
        <zip>50801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Methodist Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology and Hematology Associates-Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broadlawns Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center - Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Cancer and Blood - Laurel</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Iowa Lutheran Hospital</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50316</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Trinity Cancer Center</name>
      <address>
        <city>Fort Dodge</city>
        <state>Iowa</state>
        <zip>50501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Regional Medical Center</name>
      <address>
        <city>Fort Dodge</city>
        <state>Iowa</state>
        <zip>50501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Jefferson</name>
      <address>
        <city>Jefferson</city>
        <state>Iowa</state>
        <zip>50129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Marshalltown</name>
      <address>
        <city>Marshalltown</city>
        <state>Iowa</state>
        <zip>50158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist West Hospital</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266-7700</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center-West Lakes</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Care Cancer Center - Garden City</name>
      <address>
        <city>Garden City</city>
        <state>Kansas</state>
        <zip>67846</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Care Cancer Center - Great Bend</name>
      <address>
        <city>Great Bend</city>
        <state>Kansas</state>
        <zip>67530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flaget Memorial Hospital</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commonwealth Cancer Center-Corbin</name>
      <address>
        <city>Corbin</city>
        <state>Kentucky</state>
        <zip>40701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Radiation Oncology Resource Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital East</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph London</name>
      <address>
        <city>London</city>
        <state>Kentucky</state>
        <zip>40741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saints Mary and Elizabeth Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UofL Health Medical Center Northeast</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish Hospital Medical Center South</name>
      <address>
        <city>Shepherdsville</city>
        <state>Kentucky</state>
        <zip>40165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LSU Health Baton Rouge-North Clinic</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana Hematology Oncology Associates LLC</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Bird Perkins Cancer Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Our Lady of the Lake Physicians Group - Medical Oncology</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Brighton</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health IHA Medical Group Hematology Oncology - Brighton</name>
      <address>
        <city>Brighton</city>
        <state>Michigan</state>
        <zip>48114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Canton</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health IHA Medical Group Hematology Oncology - Canton</name>
      <address>
        <city>Canton</city>
        <state>Michigan</state>
        <zip>48188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caro Cancer Center</name>
      <address>
        <city>Caro</city>
        <state>Michigan</state>
        <zip>48723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Chelsea</name>
      <address>
        <city>Chelsea</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital</name>
      <address>
        <city>Chelsea</city>
        <state>Michigan</state>
        <zip>48118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Oncology Consultants-Clarkston</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newland Medical Associates-Clarkston</name>
      <address>
        <city>Clarkston</city>
        <state>Michigan</state>
        <zip>48346</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint John Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Doctors Park</name>
      <address>
        <city>East China Township</city>
        <state>Michigan</state>
        <zip>48054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesee Cancer and Blood Disease Treatment Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesee Hematology Oncology PC</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesys Hurley Cancer Institute</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hurley Medical Center</name>
      <address>
        <city>Flint</city>
        <state>Michigan</state>
        <zip>48503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Hematology Oncology Specialists</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Van Elslander Cancer Center</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Breast Specialists-Grosse Pointe Woods</name>
      <address>
        <city>Grosse Pointe Woods</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparrow Hospital</name>
      <address>
        <city>Lansing</city>
        <state>Michigan</state>
        <zip>48912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Cancer Clinic</name>
      <address>
        <city>Livonia</city>
        <state>Michigan</state>
        <zip>48154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health Saint Mary Mercy Livonia Hospital</name>
      <address>
        <city>Livonia</city>
        <state>Michigan</state>
        <zip>48154</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Macomb Medical Campus</name>
      <address>
        <city>Macomb</city>
        <state>Michigan</state>
        <zip>48044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Breast Specialists-Macomb Township</name>
      <address>
        <city>Macomb</city>
        <state>Michigan</state>
        <zip>48044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Oncology/Hematology Associates of Marlette</name>
      <address>
        <city>Marlette</city>
        <state>Michigan</state>
        <zip>48453</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>21st Century Oncology-Pontiac</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hope Cancer Center</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Newland Medical Associates-Pontiac</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Mercy Oakland</name>
      <address>
        <city>Pontiac</city>
        <state>Michigan</state>
        <zip>48341</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Rochester Hills</name>
      <address>
        <city>Rochester Hills</city>
        <state>Michigan</state>
        <zip>48309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Mary's Hospital</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Associates of Saginaw Valley PC</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bhadresh Nayak MD PC-Sterling Heights</name>
      <address>
        <city>Sterling Heights</city>
        <state>Michigan</state>
        <zip>48312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Joseph Hospital</name>
      <address>
        <city>Tawas City</city>
        <state>Michigan</state>
        <zip>48764</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Breast Care Center PLLC</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Cancer Management Specialists-Macomb Professional Building</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Macomb Hematology Oncology PC</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michigan Breast Specialists-Warren</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint John Macomb-Oakland Hospital</name>
      <address>
        <city>Warren</city>
        <state>Michigan</state>
        <zip>48093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Oncology/Hematology Associates of West Branch</name>
      <address>
        <city>West Branch</city>
        <state>Michigan</state>
        <zip>48661</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huron Gastroenterology PC</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus</name>
      <address>
        <city>Ypsilanti</city>
        <state>Michigan</state>
        <zip>48197</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Joe Lueken Cancer Center</name>
      <address>
        <city>Bemidji</city>
        <state>Minnesota</state>
        <zip>56601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Thief River Falls Medical Center</name>
      <address>
        <city>Thief River Falls</city>
        <state>Minnesota</state>
        <zip>56701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Center Worthington</name>
      <address>
        <city>Worthington</city>
        <state>Minnesota</state>
        <zip>56187</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis Cancer and Breast Institute-Ballwin</name>
      <address>
        <city>Ballwin</city>
        <state>Missouri</state>
        <zip>63011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Care Cancer Center - Bolivar</name>
      <address>
        <city>Bolivar</city>
        <state>Missouri</state>
        <zip>65613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Medical Center</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Cancer Center</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at West County Hospital</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkland Health Center - Farmington</name>
      <address>
        <city>Farmington</city>
        <state>Missouri</state>
        <zip>63640</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Region Southwest Campus</name>
      <address>
        <city>Jefferson City</city>
        <state>Missouri</state>
        <zip>65109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Freeman Health System</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Joplin</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delbert Day Cancer Institute at PCRMC</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic-Rolla-Cancer and Hematology</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Regional Medical Center</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis Cancer and Breast Institute-South City</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital South</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center-South County</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Christian Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Saint Peters Hospital</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63376</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sainte Genevieve County Memorial Hospital</name>
      <address>
        <city>Sainte Genevieve</city>
        <state>Missouri</state>
        <zip>63670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CoxHealth South Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Sullivan Hospital</name>
      <address>
        <city>Sullivan</city>
        <state>Missouri</state>
        <zip>63080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Outpatient Center-Sunset Hills</name>
      <address>
        <city>Sunset Hills</city>
        <state>Missouri</state>
        <zip>63127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Washington</name>
      <address>
        <city>Washington</city>
        <state>Missouri</state>
        <zip>63090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital of Anaconda</name>
      <address>
        <city>Anaconda</city>
        <state>Montana</state>
        <zip>59711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bozeman Deaconess Hospital</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benefis Healthcare- Sletten Cancer Institute</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Falls Clinic</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kalispell Regional Medical Center</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Patrick Hospital - Community Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Medical Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Health Saint Francis</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Health Good Samaritan</name>
      <address>
        <city>Kearney</city>
        <state>Nebraska</state>
        <zip>68847</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Regional Medical Center</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Immanuel Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Bergan Mercy Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Lakeside Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Creighton University Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midlands Community Hospital</name>
      <address>
        <city>Papillion</city>
        <state>Nebraska</state>
        <zip>68046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Bismarck Medical Center</name>
      <address>
        <city>Bismarck</city>
        <state>North Dakota</state>
        <zip>58501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford South University Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southpointe-Sanford Medical Center Fargo</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Medical Center Fargo</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Broadway Medical Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Roger Maris Cancer Center</name>
      <address>
        <city>Fargo</city>
        <state>North Dakota</state>
        <zip>58122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indu and Raj Soin Medical Center</name>
      <address>
        <city>Beavercreek</city>
        <state>Ohio</state>
        <zip>45431</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Boardman Hospital</name>
      <address>
        <city>Boardman</city>
        <state>Ohio</state>
        <zip>44512</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Physicians LLC-Miami Valley South</name>
      <address>
        <city>Centerville</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Valley Hospital South</name>
      <address>
        <city>Centerville</city>
        <state>Ohio</state>
        <zip>45459</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Center-UC Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Hospital - Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oncology Hematology Care Inc-Kenwood</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda North Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriHealth Cancer Institute-Westside</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriHealth Cancer Institute-Anderson</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Valley Hospital</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Physician LLC-Miami Valley Hospital North</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Miami Valley Hospital North</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Armes Family Cancer Center</name>
      <address>
        <city>Findlay</city>
        <state>Ohio</state>
        <zip>45840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blanchard Valley Hospital</name>
      <address>
        <city>Findlay</city>
        <state>Ohio</state>
        <zip>45840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orion Cancer Care</name>
      <address>
        <city>Findlay</city>
        <state>Ohio</state>
        <zip>45840</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Atrium Medical Center-Middletown Regional Hospital</name>
      <address>
        <city>Franklin</city>
        <state>Ohio</state>
        <zip>45005-1066</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Physicians LLC-Atrium</name>
      <address>
        <city>Franklin</city>
        <state>Ohio</state>
        <zip>45005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Physicians LLC-Wayne</name>
      <address>
        <city>Greenville</city>
        <state>Ohio</state>
        <zip>45331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wayne Hospital</name>
      <address>
        <city>Greenville</city>
        <state>Ohio</state>
        <zip>45331</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Dayton Cancer Center</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45409</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kettering Medical Center</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield Regional Cancer Center</name>
      <address>
        <city>Springfield</city>
        <state>Ohio</state>
        <zip>45504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield Regional Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Ohio</state>
        <zip>45505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Physicians LLC - Troy</name>
      <address>
        <city>Troy</city>
        <state>Ohio</state>
        <zip>45373</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Upper Valley Medical Center</name>
      <address>
        <city>Troy</city>
        <state>Ohio</state>
        <zip>45373</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Warren Hospital</name>
      <address>
        <city>Warren</city>
        <state>Ohio</state>
        <zip>44484</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Center-West Chester</name>
      <address>
        <city>West Chester</city>
        <state>Ohio</state>
        <zip>45069</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Youngstown Hospital</name>
      <address>
        <city>Youngstown</city>
        <state>Ohio</state>
        <zip>44501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Centers of Southwest Oklahoma Research</name>
      <address>
        <city>Lawton</city>
        <state>Oklahoma</state>
        <zip>73505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Oklahoma City</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Medical Center-Baker City</name>
      <address>
        <city>Baker City</city>
        <state>Oregon</state>
        <zip>97814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Charles Health System</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clackamas Radiation Oncology Center</name>
      <address>
        <city>Clackamas</city>
        <state>Oregon</state>
        <zip>97015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Cancer Institute Clackamas Clinic</name>
      <address>
        <city>Clackamas</city>
        <state>Oregon</state>
        <zip>97015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Hospital</name>
      <address>
        <city>Coos Bay</city>
        <state>Oregon</state>
        <zip>97420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Newberg Medical Center</name>
      <address>
        <city>Newberg</city>
        <state>Oregon</state>
        <zip>97132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Medical Center-Ontario</name>
      <address>
        <city>Ontario</city>
        <state>Oregon</state>
        <zip>97914</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Saint Vincent Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Charles Health System-Redmond</name>
      <address>
        <city>Redmond</city>
        <state>Oregon</state>
        <zip>97756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital-Cedar Crest</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital - Muhlenberg</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pocono Medical Center</name>
      <address>
        <city>East Stroudsburg</city>
        <state>Pennsylvania</state>
        <zip>18301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital-Hazleton</name>
      <address>
        <city>Hazleton</city>
        <state>Pennsylvania</state>
        <zip>18201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Center Oncology Clinic</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center - Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117-5134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Regional Cancer Center</name>
      <address>
        <city>Bryan</city>
        <state>Texas</state>
        <zip>77802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VCU Massey Cancer Center at Stony Point</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer System-Aberdeen</name>
      <address>
        <city>Aberdeen</city>
        <state>Washington</state>
        <zip>98520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Saint Joseph Medical Center</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98225</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison HealthPartners Hematology and Oncology-Bremerton</name>
      <address>
        <city>Bremerton</city>
        <state>Washington</state>
        <zip>98310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison Medical Center</name>
      <address>
        <city>Bremerton</city>
        <state>Washington</state>
        <zip>98310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highline Medical Center-Main Campus</name>
      <address>
        <city>Burien</city>
        <state>Washington</state>
        <zip>98166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer System-Centralia</name>
      <address>
        <city>Centralia</city>
        <state>Washington</state>
        <zip>98531</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute-Edmonds</name>
      <address>
        <city>Edmonds</city>
        <state>Washington</state>
        <zip>98026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Hospital</name>
      <address>
        <city>Enumclaw</city>
        <state>Washington</state>
        <zip>98022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer Partnership</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Hospital</name>
      <address>
        <city>Federal Way</city>
        <state>Washington</state>
        <zip>98003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute-Issaquah</name>
      <address>
        <city>Issaquah</city>
        <state>Washington</state>
        <zip>98029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kadlec Clinic Hematology and Oncology</name>
      <address>
        <city>Kennewick</city>
        <state>Washington</state>
        <zip>99336</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer System-Lacey</name>
      <address>
        <city>Lacey</city>
        <state>Washington</state>
        <zip>98503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Clare Hospital</name>
      <address>
        <city>Lakewood</city>
        <state>Washington</state>
        <zip>98499</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Saint John Medical Center</name>
      <address>
        <city>Longview</city>
        <state>Washington</state>
        <zip>98632</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison HealthPartners Hematology and Oncology-Poulsbo</name>
      <address>
        <city>Poulsbo</city>
        <state>Washington</state>
        <zip>98370</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pacific Gynecology Specialists</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center-Ballard Campus</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center-Cherry Hill</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122-5711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center-First Hill</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeaceHealth United General Medical Center</name>
      <address>
        <city>Sedro-Woolley</city>
        <state>Washington</state>
        <zip>98284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer System-Shelton</name>
      <address>
        <city>Shelton</city>
        <state>Washington</state>
        <zip>98584</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Research Center-Northwest Medical Plaza</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialties PLLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Southwest Medical Center</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98664</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Saint Mary Regional Cancer Center</name>
      <address>
        <city>Walla Walla</city>
        <state>Washington</state>
        <zip>99362</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer System-Yelm</name>
      <address>
        <city>Yelm</city>
        <state>Washington</state>
        <zip>98597</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center Green Bay</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Vincent Hospital Cancer Center at Saint Mary's</name>
      <address>
        <city>Green Bay</city>
        <state>Wisconsin</state>
        <zip>54303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic-Cody</name>
      <address>
        <city>Cody</city>
        <state>Wyoming</state>
        <zip>82414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Welch Cancer Center</name>
      <address>
        <city>Sheridan</city>
        <state>Wyoming</state>
        <zip>82801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network-Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chinese University of Hong Kong-Prince of Wales Hospital</name>
      <address>
        <city>Shatin</city>
        <state>Hong Kong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>168583</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>China</country>
    <country>Singapore</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>September 12, 2023</last_update_submitted>
  <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Carcinoma, Squamous Cell</mesh_term>
    <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
    <mesh_term>Recurrence</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.</ipd_description>
    <ipd_url>https://grants.nih.gov/policy/sharing.htm</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04458909
org study id: NCI-2020-04581
secondary id: NCI-2020-04581
secondary id: NRG-HN007
secondary id: NRG-HN007
secondary id: U10CA180868
nct id: NCT04458909
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase III trial compares the effect of adding nivolumab to the usual chemotherapy
      (cisplatin or carboplatin with gemcitabine) versus standard chemotherapy alone in treating
      patients with nasopharyngeal cancer that has come back (recurrent) or spread to other places
      in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, may
      help the body's immune system attack the cancer, and may interfere with the ability of tumor
      cells to grow and spread. Chemotherapy drugs, such as cisplatin, carboplatin, and
      gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the
      cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab
      with the usual chemotherapy may work better than the standard chemotherapy alone in treating
      patients with nasopharyngeal cancer.
PRIMARY OBJECTIVE:

      I. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment improves
      overall survival (OS) for patients with recurrent and/or metastatic nasopharyngeal carcinoma
      (NPC).

      SECONDARY OBJECTIVES:

      I. To compare patterns of failure (local-regional relapse and distant metastasis) between
      treatment arms.

      II. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment improves
      the objective tumor response based on Response Evaluation Criteria in Solid Tumors (RECIST)
      1.1.

      III. To determine if adding nivolumab to platinum-gemcitabine as first-line treatment
      improves progression free survival (PFS) for patients with recurrent and/or metastatic NPC.

      IV. To evaluate the toxicity based on the Common Terminology Criteria for Adverse Events
      (CTCAE) version (v)5.0.

      V. To characterize patient-reported symptomatic toxicities measured by Patient-Reported
      Outcomes (PRO)-CTCAE.

      VI. To assess the quality of life (QOL), as measured by the European Organization for
      Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Core (C)30,
      between the two arms (primary PRO).

      VII. To assess fatigue, as measured by Multidimensional Fatigue Inventory (MFI-20), between
      the two arms (secondary PRO).

      VIII. To determine if a subset of patients based on an optimal cutoff point of PD-L1 Combined
      Positive Score (CPS)/Tumor Proportion Score (TPS) is more likely to benefit in terms of PFS
      from adding nivolumab to platinum-gemcitabine as first-line treatment.

      EXPLORATORY OBJECTIVES:

      I. To determine if a subset of patients based on an optimal cutoff point of PD-L1 CPS/TPS is
      more likely to benefit in terms of overall survival (OS) from adding nivolumab to
      platinum-gemcitabine as first-line treatment.

      II. To determine changes in QOL as measured by EORTC QLQ-C30 and in fatigue as measured by
      MFI-20, between and within arms over time (exploratory PRO).

      III. To collect blood and tissue specimens for future translational research.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1, gemcitabine IV
      over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over
      30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of
      disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab
      IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the
      absence of disease progression or unacceptable toxicity.

      ARM II: Patients receive gemcitabine and cisplatin or carboplatin as in Arm I.

      After completion of study treatment, patients are followed up every 4 months for 2 years,
      every 6 months for 3 years, and then annually.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS)
time frame: From randomization until death due to any cause or last follow-up. Analysis occurs after 200 deaths have been reported, assessed up to 8 years
description: Overall survival rates for both treatment arms will be estimated using the Kaplan-Meier method. The comparison of OS distributions between treatment arms will be done using a log-rank test.
measure: Locoregional failure
time frame: From randomization until local or regional progression, death, or last follow-up, assessed up to 8 years
description: Rates estimated by cumulative incidence method and arms compared by cause-specific log-rank test.
measure: Distant metastases
time frame: From randomization until distant progression, death, or last follow-up, assessed up to 8 years
description: Rates estimated by cumulative incidence method and arms compared by cause-specific log-rank test.
measure: Progression-free survival (PFS)
time frame: From randomization until progression or death due to any cause, or last follow-up, assessed up to 8 years
description: Rates estimated using the Kaplan-Meier method and between-arm differences compared using the log-rank test.
measure: Tumor response
time frame: From randomization to last follow-up, assessed up to 8 years
description: Will be assessed by Response Evaluation Criteria in Solid Tumors 1.1. The Objective Response Rate (ORR), defined as the proportion of confirmed complete and partial response, will be calculated with their respective 95% confidence intervals (CI). An estimate of the difference in ORR between the experimental and control arms along with the 95% CI, will also be provided. The between-arm difference in ORR will be assessed using a chi-square test for proportions based on normal approximation. The confidence intervals will be also based on a normal approximation.
measure: Incidence of adverse events (AEs)
time frame: From start of treatment to last follow-up, assessed up to 8 years
description: Will be assessed by Common Terminology Criteria for Adverse Events version 5.0. Counts of all AEs by grade will be provided by the treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient's treatment arm. The number of patients with at least 1 grade 3 or higher AE will be compared between the treatment arms. All comparisons will be tested using a chi-Square test, or Fisher's exact test if cell frequencies are < 5, with a significance level of 0.05. Toxicity analyses will be based on an as-treated population, including all patients who received at least one dose of the assigned trial treatment.
measure: Patient-reported symptomatic toxicities
time frame: From randomization to 2 years
description: Will be assessed by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE). The proportion of patients with scores >= 1 and >= 3 will be compared between groups using a Chi-square test, or Fisher's exact test if cell frequencies are < 5, using a significance level of 0.05. Analysis of changes in patient reported outcomes over time will be analyzed by fitting generalized estimating equation (GEE) models using a logit link (dichotomizing the symptom scores as 0 versus [vs.] > 1 and 0-2 vs. 3-4) with the time of assessment, treatment arm, and treatment-by-time interaction terms in the model.
measure: Quality of life
time frame: From randomization to 2 years
description: Will be assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30).
measure: Fatigue
time frame: From randomization to 2 years
description: Will be assessed by Multidimensional Fatigue Inventory (MFI-20).
measure: Progression-free survival by PD-L1 Combined Positive Score (CPS)/Tumor Proportion Score (TPS) cut-off
time frame: From randomization until progression or death due to any cause, or last follow-up, assessed up to 8 years
description: Will be assessed based on PD-L1 CPS/TPS cut-off.
measure: Overall survival by PD-L1 CPS/TPS cut-off
time frame: From randomization until death due to any cause or last follow-up, assessed up to 8 years
description: Will be assessed based on PD-L1 CPS/TPS cut-off.
measure: Change in quality of life
time frame: From randomization to 2 years
description: Will be measured by EORTC QLQ-C30 between and within arms over time.
measure: Change in fatigue
time frame: From randomization to 2 years
description: Will be measured by MFI-20 between and within arms over time.
measure: Translational research studies
time frame: From randomization to last follow-up, assessed up to 8 years
arm group label: Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)
arm group type: Experimental
description: Patients receive nivolumab IV over 30 minutes on day 1, gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 30-60 minutes or carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. After 4 weeks, patients then receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
arm group label: Arm II (gemcitabine, cisplatin, carboplatin)
arm group type: Active Comparator
description: Patients receive gemcitabine and cisplatin or carboplatin as in Arm I.
intervention type: Drug
intervention name: Carboplatin
description: Given IV
arm group label: Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)
arm group label: Arm II (gemcitabine, cisplatin, carboplatin)
other name: Blastocarb
other name: Carboplat
other name: Carboplatin Hexal
other name: Carboplatino
other name: Carboplatinum
other name: Carbosin
other name: Carbosol
other name: Carbotec
other name: CBDCA
other name: Displata
other name: Ercar
other name: JM-8
other name: JM8
other name: Nealorin
other name: Novoplatinum
other name: Paraplatin
other name: Paraplatin AQ
other name: Paraplatine
other name: Platinwas
other name: Ribocarbo
intervention type: Drug
intervention name: Cisplatin
description: Given IV
arm group label: Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)
arm group label: Arm II (gemcitabine, cisplatin, carboplatin)
other name: Abiplatin
other name: Blastolem
other name: Briplatin
other name: CDDP
other name: Cis-diammine-dichloroplatinum
other name: Cis-diamminedichloridoplatinum
other name: Cis-diamminedichloro Platinum (II)
other name: Cis-diamminedichloroplatinum
other name: Cis-dichloroammine Platinum (II)
other name: Cis-platinous Diamine Dichloride
other name: Cis-platinum
other name: Cis-platinum II
other name: Cis-platinum II Diamine Dichloride
other name: Cismaplat
other name: Cisplatina
other name: Cisplatinum
other name: Cisplatyl
other name: Citoplatino
other name: Citosin
other name: Cysplatyna
other name: DDP
other name: Lederplatin
other name: Metaplatin
other name: Neoplatin
other name: Peyrone's Chloride
other name: Peyrone's Salt
other name: Placis
other name: Plastistil
other name: Platamine
other name: Platiblastin
other name: Platiblastin-S
other name: Platinex
other name: Platinol
other name: Platinol- AQ
other name: Platinol-AQ
other name: Platinol-AQ VHA Plus
other name: Platinoxan
other name: Platinum
other name: Platinum Diamminodichloride
other name: Platiran
other name: Platistin
other name: Platosin
intervention type: Drug
intervention name: Gemcitabine
description: Given IV
arm group label: Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)
arm group label: Arm II (gemcitabine, cisplatin, carboplatin)
other name: dFdC
other name: dFdCyd
other name: Difluorodeoxycytidine
intervention type: Biological
intervention name: Nivolumab
description: Given IV
arm group label: Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)
other name: ABP 206
other name: BMS-936558
other name: CMAB819
other name: MDX-1106
other name: NIVO
other name: Nivolumab Biosimilar ABP 206
other name: Nivolumab Biosimilar CMAB819
other name: ONO-4538
other name: Opdivo
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm I (nivolumab, gemcitabine, cisplatin, carboplatin)
arm group label: Arm II (gemcitabine, cisplatin, carboplatin)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Brigette B Ma
role: Principal Investigator
affiliation: NRG Oncology
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country: Canada
country: China
country: Singapore
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Squamous Cell
mesh term: Nasopharyngeal Carcinoma
mesh term: Recurrence
mesh term: Cisplatin
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Nivolumab
sharing ipd: Yes
ipd description: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
ipd url: https://grants.nih.gov/policy/sharing.htm