<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/NCT03274258</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0201</org_study_id>
    <secondary_id>NCI-2018-01066</secondary_id>
    <secondary_id>2017-0201</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT03274258</nct_id>
  </id_info>
  <brief_title>Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma</brief_title>
  <official_title>Phase II Trial of Nivolumab Plus Ipilimumab in Patients With Renal Medullary Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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 II trial studies how well nivolumab and ipilimumab work in treating patients with&#xD;
      kidney cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab,&#xD;
      may help the body's immune system attack the cancer, and may interfere with the ability of&#xD;
      tumor cells to grow and spread.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the objective response rate (ORR) of patients with locally advanced or&#xD;
      metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus&#xD;
      ipilimumab.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the efficacy and safety of the combination of nivolumab plus ipilimumab in&#xD;
      patients with RMC.&#xD;
&#xD;
      II. To evaluate potential biomarkers for patient stratification and treatment response, as&#xD;
      well as tumor antigen-specific immune responses, such as antibody and T cell responses, as&#xD;
      surrogates for anti-tumor activity.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90&#xD;
      minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of&#xD;
      disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60&#xD;
      minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 13, 2017</start_date>
  <completion_date type="Anticipated">July 31, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR) defined as completion response or partial response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria</measure>
    <time_frame>At 12 weeks</time_frame>
    <description>Descriptive statistics will include tabulations of frequencies. The estimate of the posterior ORR and its 95% credible interval will be estimated using the same prior as utilized in the futility monitoring rules. The posterior distribution for ORR of this trial will be compared to the historical data. The Kaplan-Meier method will be utilized to display time to ORR. Association with ORR, clinical benefit rate (CBR), or toxicity (TOX) events will be explored with logistic regression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Progression-free survival (PFS) assessed by RECIST criteria</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The Kaplan-Meier method will be utilized to display PFS.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Adverse effects that will be evaluated include, but are not limited to infections, renal toxicity, hepatic toxicity, and pulmonary toxicity. Methods of assessment will include monitoring blood counts, and performing laboratory tests as indicated by clinical signs and symptoms. Evidence of toxicity or adverse events will be recorded at all clinic visits. All observed adverse effects will be graded for all patients and the degree of association of each with therapy assessed.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Kidney Medullary Carcinoma</condition>
  <condition>Loss of INI 1 Protein Expression</condition>
  <condition>Stage III Renal Cell Cancer AJCC v8</condition>
  <condition>Stage IV Renal Cell Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Treatment (nivolumab, ipilimumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (nivolumab, ipilimumab)</arm_group_label>
    <other_name>Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody</other_name>
    <other_name>BMS-734016</other_name>
    <other_name>MDX-010</other_name>
    <other_name>MDX-CTLA4</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (nivolumab, ipilimumab)</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>MDX-1106</other_name>
    <other_name>NIVO</other_name>
    <other_name>ONO-4538</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must give written informed consent prior to initiation of therapy, in keeping&#xD;
             with the policies of the institution. Patients with a history of major psychiatric&#xD;
             illness must be judged able to fully understand the investigational nature of the&#xD;
             study and the risks associated with the therapy.&#xD;
&#xD;
          -  Patients with locally advanced or metastatic RMC histologically confirmed by expert&#xD;
             pathology review and loss of SMARCB1 staining by immunohistochemistry. Patients with&#xD;
             advanced or metastatic unclassified renal cell carcinoma with medullary phenotype (a&#xD;
             rare SMARCB1 negative RMC variant occurring in individuals without sickle&#xD;
             hemoglobinopathies) are also eligible. The principal investigator (PI) is the final&#xD;
             arbiter in questions related to eligibility.&#xD;
&#xD;
          -  Patients will be eligible regardless of whether they have had prior nephrectomy or&#xD;
             still have their primary tumor in-situ.&#xD;
&#xD;
          -  Patients must have at least one measurable site of disease, defined as a lesion that&#xD;
             can be accurately measured in at least one dimension (longest diameter to be recorded)&#xD;
             and measures &gt;= 15 mm with conventional techniques or &gt;= 10 mm with more sensitive&#xD;
             techniques such as magnetic resonance imaging (MRI) or spiral computerized tomography&#xD;
             (CT) scan. If the patient has had previous radiation to the marker lesion(s), there&#xD;
             must be evidence of progression since the radiation.&#xD;
&#xD;
          -  Patients should be willing to provide a newly obtained fresh core biopsy of a tumor&#xD;
             lesion. Not required if there is a recently obtained fresh specimen on an&#xD;
             Institutional Review Board (IRB) approved correlated trial up to 6 weeks (42 days)&#xD;
             prior to initiation of treatment on day 1.&#xD;
&#xD;
          -  Patients can be either naive for any previous systemic treatment or have had any&#xD;
             number of prior systemic therapies. However, patients must not have received prior&#xD;
             anticancer therapy with anti-PD1, anti-PD-L1, or anti-CTLA-4 immune checkpoint&#xD;
             inhibitors.&#xD;
&#xD;
          -  There must be evidence of progression on or after last treatment regimen received.&#xD;
             NOTE: If subject is unable to walk due to paralysis, but is mobile in a wheelchair,&#xD;
             subject is considered to be ambulatory for the purpose of assessing their performance&#xD;
             status.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2.&#xD;
&#xD;
          -  Consent to MD Anderson companion laboratory protocol 2014-0938.&#xD;
&#xD;
          -  Hemoglobin &gt;= 9 g/dl (treatment allowed) (within 14 days of the first dose of the&#xD;
             study drugs).&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1000/mcL (within 14 days of the first dose of the study&#xD;
             drugs).&#xD;
&#xD;
          -  Platelets &gt;= 75,000/L (within 14 days of the first dose of the study drugs).&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 mg/dl (within 14 days of the first dose of the study drugs).&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) or&#xD;
             alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =&lt; 2.5 X&#xD;
             institutional upper limit of normal (ULN), except in known hepatic metastasis, wherein&#xD;
             may be =&lt; 5 x ULN (within 14 days of the first dose of the study drugs).&#xD;
&#xD;
          -  Serum creatinine =&lt; 1.5 x ULN by gender (as long as patient does not require dialysis)&#xD;
             (within 14 days of the first dose of the study drugs); May receive transfusion;&#xD;
             Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days; If&#xD;
             creatinine is not &lt; 1.5 x ULN, then calculate by Cockcroft-Gault methods or local&#xD;
             institutional standard and creatinine clearance (CrCl) must be &gt; 30 mL/kg/1.73 m^2.&#xD;
&#xD;
          -  International normalized ratio (INR) and partial thromboplastin time (PTT) =&lt; 1.5 x&#xD;
             ULN prior to study entry. Therapeutic anticoagulation with warfarin is allowed if&#xD;
             target INR =&lt; 3 on a stable dose of warfarin or on a stable dose of low molecular&#xD;
             weight (LMW) heparin for &gt; 2 weeks (14 days) at the time of enrollment.&#xD;
&#xD;
          -  Patients with controlled brain metastases are allowed on protocol if they had solitary&#xD;
             brain metastases that was surgically resected or treated with radiosurgery or Gamma&#xD;
             knife, without recurrence or edema for 1 month (4 weeks).&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy&#xD;
             test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin&#xD;
             [HCG]) within 24 hours prior to the start of the study drug.&#xD;
&#xD;
          -  Women must not be breastfeeding.&#xD;
&#xD;
          -  WOCBP must agree to follow instructions for method(s) of contraception from the time&#xD;
             of enrollment for the duration of treatment with study drug (s) plus 5 half-lives of&#xD;
             study drug (s) plus 30 days (duration of ovulatory cycle) for a total of 5 months post&#xD;
             treatment completion.&#xD;
&#xD;
          -  Men who are sexually active with WOCBP must agree to follow instructions for method(s)&#xD;
             of contraception for the duration of treatment with study drug (s) plus 5 half-lives&#xD;
             of study drug (s) plus 90 days duration of sperm turnover for a total of 5 months&#xD;
             post-treatment completion.&#xD;
&#xD;
          -  Azoospermic males and WOCBP who are continuously not heterosexually active are exempt&#xD;
             from contraceptive requirements. However WOCBP must still undergo pregnancy testing as&#xD;
             described in these sections.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients must not have any other malignancies within the past 2 years except for in&#xD;
             situ carcinoma of any site, or adequately treated (without recurrence post-resection&#xD;
             or post-radiotherapy) carcinoma of the cervix or basal or squamous cell carcinomas of&#xD;
             the skin.&#xD;
&#xD;
          -  Patients currently receiving anticancer therapies or who have received anticancer&#xD;
             therapies (including chemotherapy and targeted therapy) within 2 weeks (14 days) prior&#xD;
             to study day are excluded. Patients who have completed palliative radiation therapy&#xD;
             more than 14 days prior to the first dose of the combination ipilimumab plus nivolumab&#xD;
             are eligible.&#xD;
&#xD;
          -  Patients, who have had a major surgery or significant traumatic injury (injury&#xD;
             requiring &gt; 4 weeks [28 days] to heal) within 4 weeks (28 days) of start of study&#xD;
             drug, patients who have not recovered from the side effects of any major surgery&#xD;
             (defined as requiring general anesthesia) or patients that are expected to require&#xD;
             major surgery, other than cytoreductive nephrectomy +/- retroperitoneal lymph node&#xD;
             dissection, during the course of the study.&#xD;
&#xD;
          -  Patients who have organ allografts.&#xD;
&#xD;
          -  Known or suspected autoimmune disease. Patients with a history of inflammatory bowel&#xD;
             disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders&#xD;
             such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic&#xD;
             lupus erythematosus or autoimmune vasculitis (e.g., Wegener's granulomatosis) are&#xD;
             excluded from this study. Patients with a history of Hashimoto's thyroiditis only&#xD;
             requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic&#xD;
             treatment, or conditions not expected to recur in the absence of an external trigger&#xD;
             are allowed to participate.&#xD;
&#xD;
          -  Known history of testing positive for human immunodeficiency virus (HIV) or known&#xD;
             acquired immunodeficiency syndrome (AIDS).&#xD;
&#xD;
          -  Positive test for hepatitis B virus (HBV) using HBV surface antigen (HBVsAg) test or&#xD;
             positive test for hepatitis C virus (HCV) using HCV ribonucleic acid (RNA) or HCV&#xD;
             antibody test indicating acute or chronic infection. If hepatitis C antibody test is&#xD;
             positive then active infection has to be confirmed by hepatitis C RNA testing for the&#xD;
             patient to be excluded.&#xD;
&#xD;
          -  Any underlying medical condition, which in the opinion of the investigator, will make&#xD;
             the administration of study drug hazardous or obscure the interpretation of adverse&#xD;
             events, such as a condition associated with frequent diarrhea, uncontrolled nausea or&#xD;
             vomiting.&#xD;
&#xD;
          -  Patients must not have received prior anticancer therapy with anti-PD1, anti-PD-L1, or&#xD;
             anti- CTLA-4 immune checkpoint inhibitors.&#xD;
&#xD;
          -  Patients receiving any concomitant systemic therapy for renal cell cancer are&#xD;
             excluded.&#xD;
&#xD;
          -  Patients must not be scheduled to receive another experimental drug while on this&#xD;
             study.&#xD;
&#xD;
          -  Patients who are on high dose steroid (e.g., &gt; 10 mg prednisone daily or equivalent)&#xD;
             or other more potent immune suppression medications (e.g., infliximab). Topical,&#xD;
             inhaled, intraarticular, ocular, or intranasal corticosteroids (with minimal systemic&#xD;
             absorption) are allowed. A brief course (&lt; 48 hours) of systemic corticosteroids for&#xD;
             prophylaxis (e.g., from contrast dye allergy) is permitted. Physiological&#xD;
             corticosteroid replacement therapy for adrenal insufficiency is also permitted.&#xD;
&#xD;
          -  Patients who have any severe and/or uncontrolled medical conditions or other&#xD;
             conditions that could affect their participation in the study such as: a) Symptomatic&#xD;
             congestive heart failure of New York heart Association class III or IV; b) Unstable&#xD;
             angina pectoris, symptomatic congestive heart failure, myocardial infarction within 6&#xD;
             months of start of study drug, serious uncontrolled cardiac arrhythmia or any other&#xD;
             clinically significant cardiac disease; c) Severely impaired lung function as defined&#xD;
             as oxygen (O2) saturation that is 92% or less at rest on room air; d) Uncontrolled&#xD;
             diabetes as defined by fasting serum glucose &gt; 1.5 x ULN; e) Systemic fungal,&#xD;
             bacterial, viral, or other infection that is not controlled (defined as exhibiting&#xD;
             ongoing signs/symptoms related to the infection and without improvement) despite&#xD;
             appropriate antibiotics or other treatment; f) Known active or symptomatic viral&#xD;
             hepatitis or chronic liver disease. Uncontrolled adrenal insufficiency.&#xD;
&#xD;
          -  Patients must not have history of other diseases, metabolic dysfunction, physical&#xD;
             examination finding, or clinical laboratory finding giving reasonable suspicion of a&#xD;
             disease or condition that contraindicates the use of ipilimumab or nivolumab or that&#xD;
             might affect the interpretation of the results of the study or render the subject at&#xD;
             high risk from treatment complications.&#xD;
&#xD;
          -  Patients should not receive immunization with attenuated live vaccines within one week&#xD;
             (7 days) of study entry or during study period; Note: Seasonal influenza vaccines for&#xD;
             injection are generally inactivated flu vaccines and are allowed; however intranasal&#xD;
             influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed.&#xD;
&#xD;
          -  Uncontrolled brain or leptomeningeal metastases, including patients who continue to&#xD;
             require glucocorticoids for brain or leptomeningeal metastases.&#xD;
&#xD;
          -  Female patients who are pregnant or breast feeding, or adults of reproductive&#xD;
             potential who are not using effective birth control methods as defined above. If&#xD;
             barrier contraceptives are being used, these must be continued throughout the trial by&#xD;
             both sexes. Hormonal contraceptives are not acceptable as a sole method of&#xD;
             contraception.&#xD;
&#xD;
          -  Any patients who cannot be compliant with the appointments required in this protocol&#xD;
             must not be enrolled in this study.&#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>Nizar M Tannir</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 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, Renal Cell</mesh_term>
    <mesh_term>Carcinoma, Medullary</mesh_term>
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Neuroendocrine</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Ipilimumab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03274258
org study id: 2017-0201
secondary id: NCI-2018-01066
secondary id: 2017-0201
secondary id: P30CA016672
nct id: NCT03274258
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This phase II trial studies how well nivolumab and ipilimumab work in treating patients with
      kidney cancer. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab,
      may help the body's immune system attack the cancer, and may interfere with the ability of
      tumor cells to grow and spread.
PRIMARY OBJECTIVES:

      I. To determine the objective response rate (ORR) of patients with locally advanced or
      metastatic renal medullary carcinoma (RMC) treated with combination of nivolumab plus
      ipilimumab.

      SECONDARY OBJECTIVES:

      I. To determine the efficacy and safety of the combination of nivolumab plus ipilimumab in
      patients with RMC.

      II. To evaluate potential biomarkers for patient stratification and treatment response, as
      well as tumor antigen-specific immune responses, such as antibody and T cell responses, as
      surrogates for anti-tumor activity.

      OUTLINE:

      Patients receive nivolumab intravenously (IV) over 60 minutes and ipilimumab IV over 90
      minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of
      disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60
      minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR) defined as completion response or partial response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
time frame: At 12 weeks
description: Descriptive statistics will include tabulations of frequencies. The estimate of the posterior ORR and its 95% credible interval will be estimated using the same prior as utilized in the futility monitoring rules. The posterior distribution for ORR of this trial will be compared to the historical data. The Kaplan-Meier method will be utilized to display time to ORR. Association with ORR, clinical benefit rate (CBR), or toxicity (TOX) events will be explored with logistic regression.
measure: Progression-free survival (PFS) assessed by RECIST criteria
time frame: Up to 2 years
description: The Kaplan-Meier method will be utilized to display PFS.
measure: Incidence of adverse events
time frame: Up to 2 years
description: Adverse effects that will be evaluated include, but are not limited to infections, renal toxicity, hepatic toxicity, and pulmonary toxicity. Methods of assessment will include monitoring blood counts, and performing laboratory tests as indicated by clinical signs and symptoms. Evidence of toxicity or adverse events will be recorded at all clinic visits. All observed adverse effects will be graded for all patients and the degree of association of each with therapy assessed.
arm group label: Treatment (nivolumab, ipilimumab)
arm group type: Experimental
description: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on day 1. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
intervention type: Biological
intervention name: Ipilimumab
description: Given IV
arm group label: Treatment (nivolumab, ipilimumab)
other name: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
other name: BMS-734016
other name: MDX-010
other name: MDX-CTLA4
other name: Yervoy
intervention type: Biological
intervention name: Nivolumab
description: Given IV
arm group label: Treatment (nivolumab, ipilimumab)
other name: BMS-936558
other name: MDX-1106
other name: NIVO
other name: ONO-4538
other name: Opdivo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nizar M Tannir
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
mesh term: Carcinoma, Medullary
mesh term: Thyroid Neoplasms
mesh term: Carcinoma, Neuroendocrine
mesh term: Nivolumab
mesh term: Ipilimumab