xml: <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/NCT06019130</url>
    </required_header>
    <id_info>
      <org_study_id>EUCT: 2022-500676-59-00</org_study_id>
      <nct_id>NCT06019130</nct_id>
    </id_info>
    <brief_title>Nivolumab in Children and Adults With Nasopharyngeal Carcinoma</brief_title>
    <acronym>NPC-Nivo</acronym>
    <official_title>Nivolumab in Combination With Cisplatin and 5-Fluorouracil as Induction Therapy in Children and Adults With EBV-positive Nasopharyngeal Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>German Society for Pediatric Oncology and Hematology GPOH gGmbH</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Deutsche Krebshilfe e.V., Bonn (Germany)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>German Society for Pediatric Oncology and Hematology GPOH gGmbH</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to assess whether the addition of the immune checkpoint&#xD;
        inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a&#xD;
        complete response on MRI and PET after 3 cycles of induction therapy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        After being informed about the study and potential risks, all patients will undergo a 2-week&#xD;
        screening period to determine eligibility for study entry. After informed consent has been&#xD;
        obtained, all patients ≤ 25 years and patients &gt; 25 years without metastases will receive&#xD;
        Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to standard induction chemotherapy (3&#xD;
        blocks of cisplatin/5-fluorouracil). In patients not responding to induction chemotherapy,&#xD;
        the application of Nivolumab will be extended throughout the period of radiochemotherapy.&#xD;
  &#xD;
        Patients &gt; 25 years with metastatic disease will receive Nivolumab (4.5 mg/kg BW (max. 360&#xD;
        mg) q 3 weeks) added to induction chemotherapy with 3 blocks of cisplatin/gemcitabine.&#xD;
  &#xD;
        All patients with metastatic disease will continue to receive Nivolumab during&#xD;
        radiochemotherapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 10, 2023</start_date>
    <completion_date type="Anticipated">January 9, 2028</completion_date>
    <primary_completion_date type="Anticipated">January 9, 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>A phase-II optimum Simon design with alpha=0.1 and beta=0.2 will be used.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Complete remission rate after induction therapy</measure>
      <time_frame>MRI and PET will be done 17-22 days after start of induction therapy cycle 3 (each cycle is 21 days)</time_frame>
      <description>Complete response by MRI and PET will be determined as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall and Event-free Survival</measure>
      <time_frame>2 years after study enrolment</time_frame>
      <description>Overall and event-free survival rates will be analysed with suitable descriptive methods (Kaplan Meyer estimates with confidence intervals) and compared with historical data using descriptive log-rank tests</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Treatment-Related Adverse Events</measure>
      <time_frame>At day 0 of chemotherapy cycles 1, 2 and 3, each; at day 20-25 after beginning of chemotherapy cycle 3 (each cycle is 21 days); within 2-3 weeks after the last dose of radiotherapy; 100 days following the last dose of Nivolumab</time_frame>
      <description>Adverse events will be classified using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0 by investigator assessment. Descriptive methods (frequency tables, rates of AE's and SAE's with 95% confidence intervals) will be applied</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Efficacy based on PD-L1 expression in tumor tissue</measure>
      <time_frame>Response to induction therapy will be measured 17-22 days after start of induction therapy cycle 3 (each cycle is 21 days), event-free and overall survival will be determined 2 years after study enrolment</time_frame>
      <description>PD-L1-stained % of tumor cells at the time of diagnosis will be associated to the rate of response after induction therapy and EFS and OS</description>
    </secondary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">57</enrollment>
    <condition>Nasopharyngeal Carcinoma</condition>
    <condition>Nasopharyngeal Cancer</condition>
    <condition>Nasopharyngeal Neoplasms</condition>
    <condition>Nasopharynx Cancer</condition>
    <arm_group>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.&#xD;
  After induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy in patients with PR or a reduced boost at 54Gy in patients with CR. Cisplatin will be administered at 3x20mg/m2 in the first and last week of radiotherapy, each.&#xD;
  Radiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU/week s.c. for 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5. Patients with metastases responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab.&#xD;
  After induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy. Cisplatin will be administered at 3x20mg/m2 in the first and last week of radiotherapy, each. Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.&#xD;
  Radiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU/week s.c. for 6 months.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients &gt;25 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.&#xD;
  After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients &gt; 25 years with non-metastatic disease with SD or PD after induction therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.&#xD;
  After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients &gt; 25 years with metastatic disease at diagnosis</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 80 mg/m2 on day 1, plus gemcitabine 1,000 mg/m2/d on day 1 and day 8, respectively. Patients responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab.&#xD;
  After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Nivolumab</intervention_name>
      <description>Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases</description>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with metastatic disease at diagnosis</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with non-metastatic disease with SD or PD after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt;25 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <other_name>Opdivo</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cisplatin</intervention_name>
      <description>Cisplatin during induction chemotherapy and during radiochemotherapy in all groups</description>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with metastatic disease at diagnosis</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with non-metastatic disease with SD or PD after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt;25 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <other_name>Cisplatin Teva</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>5-Fluorouracil</intervention_name>
      <description>5-Fluoruracil during induction chemotherapy in all groups except of adults &gt; 25 years with metastatic disease at diagnosis</description>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with non-metastatic disease with SD or PD after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt;25 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <other_name>Fluorouracil-GRY</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>Gemcitabine during induction chemotherapy in patients &gt; 25 years with metastatic disease at diagnosis</description>
      <arm_group_label>Patients &gt; 25 years with metastatic disease at diagnosis</arm_group_label>
      <other_name>Gemcitabin-GRY</other_name>
    </intervention>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Radiotherapy</intervention_name>
      <description>After induction therapy in all patients</description>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with metastatic disease at diagnosis</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with non-metastatic disease with SD or PD after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt;25 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Interferon beta-1a</intervention_name>
      <description>In patients &lt; 26 years after end of radiochemotherapy for 6 months</description>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <other_name>Rebif</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>MRI</intervention_name>
      <description>At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy</description>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with metastatic disease at diagnosis</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with non-metastatic disease with SD or PD after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt;25 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PET</intervention_name>
      <description>At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI</description>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with metastatic disease at diagnosis</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with non-metastatic disease with SD or PD after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt;25 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Patient-Reported Outcomes</intervention_name>
      <description>For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment</description>
      <arm_group_label>Patients &lt; 26 y with no metastases and SD or PD after induction therapy or patients with metastases</arm_group_label>
      <arm_group_label>Patients &lt; 26 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with metastatic disease at diagnosis</arm_group_label>
      <arm_group_label>Patients &gt; 25 years with non-metastatic disease with SD or PD after induction therapy</arm_group_label>
      <arm_group_label>Patients &gt;25 years with non-metastatic disease with CR or PR after induction therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Histologically confirmed new diagnosis of nasopharyngeal carcinoma according to the&#xD;
               current WHO classification in children and adolescents, aged between 3 years and 17&#xD;
               years, OR histologically confirmed new diagnosis of EBV-positive nasopharyngeal&#xD;
               carcinoma, WHO stage II or III, in subjects ≥ 18 years&#xD;
  &#xD;
            2. Stage II or higher in patients ≤ 25 years of age, stage III and IV in patients &gt; 25&#xD;
               years of age (AJCC, 8th edition)&#xD;
  &#xD;
            3. Measurable disease by MRI per RECIST 1.1 criteria&#xD;
  &#xD;
            4. Sufficient tumor tissue to be sent for central review, including PD-L1 staining,&#xD;
               either as 1 or 2 full blocks (preferred) or a minimum of 25 slides, obtained from core&#xD;
               biopsy, punch biopsy, excisional biopsy or surgical specimen&#xD;
  &#xD;
            5. Written informed consent by legal guardians (if patient not ≥ 18 years) and patient&#xD;
               prior to study participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Newly diagnosed nasopharyngeal carcinoma, Stage I in all patients, Stage II in&#xD;
               patients &gt; 25 years of age&#xD;
  &#xD;
            2. Recurrent nasopharyngeal carcinoma&#xD;
  &#xD;
            3. Nasopharyngeal carcinoma diagnosed as second malignancy and preceding chemotherapy&#xD;
               and/or radiotherapy&#xD;
  &#xD;
            4. Prior chemotherapy and/or radiotherapy&#xD;
  &#xD;
            5. Other active malignancy&#xD;
  &#xD;
            6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or&#xD;
               any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint&#xD;
               pathways.&#xD;
  &#xD;
            7. The subject received an investigational drug within 30 days prior to inclusion into&#xD;
               this study&#xD;
  &#xD;
            8. Subjects who are enrolled in another clinical trial&#xD;
  &#xD;
            9. Subjects with prior organ allograft or allogenic bone marrow transplantation&#xD;
  &#xD;
           10. Subjects with an active, known or suspected autoimmune disease. Participants with type&#xD;
               I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders&#xD;
               (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or&#xD;
               conditions not expected to recur in the absence of an external trigger are permitted&#xD;
               to enrol.&#xD;
  &#xD;
           11. Subjects with a condition requiring systemic treatment with either corticosteroids (&gt;&#xD;
               10 mg daily prednisone equivalent) or other immunosuppressive medications within 14&#xD;
               days before start of therapy. Inhaled or topical steroids, and adrenal replacement&#xD;
               steroid doses &gt; 10 mg daily prednisone equivalent, are permitted in the absence of&#xD;
               active autoimmune disease.&#xD;
  &#xD;
           12. Any positive test for hepatitis B virus or hepatitis C virus indicating acute or&#xD;
               chronic infection&#xD;
  &#xD;
           13. Known history of testing positive for human immunodeficiency virus (HIV) or known&#xD;
               acquired immunodeficiency syndrome (AIDS).&#xD;
  &#xD;
           14. Inadequate hematologic, renal or hepatic function defined by any of the following&#xD;
               screening laboratory values:&#xD;
  &#xD;
                 1. WBC &lt; 2 000/µl&#xD;
  &#xD;
                 2. Neutrophils &lt; 1 500/µl&#xD;
  &#xD;
                 3. Platelets &lt; 100 x 10e3/µL&#xD;
  &#xD;
                 4. Hemoglobin &lt; 9.0 g/dL&#xD;
  &#xD;
                 5. Creatinine &gt;1.5 x ULN or creatinine clearance &lt; 50 mL/min (using the Cockcroft&#xD;
                    Gault formula or Schwartz formula in patients &lt; 18 years)&#xD;
  &#xD;
                 6. AST/ALT &gt; 3 x ULN (&gt; 5 x ULN if liver metastases)&#xD;
  &#xD;
                 7. Total Bilirubin &gt; 1.5 x ULN (except subjects with Gilbert Syndrome who must have&#xD;
                    a total bilirubin level ≥ 3.0 x ULN)&#xD;
  &#xD;
           15. Hearing loss &gt; 20 dB loss at 3 kHz due to an inner ear disorder and not caused by&#xD;
               tumour burden&#xD;
  &#xD;
           16. History of allergy or hypersensitivity to platinum-containing compounds or other study&#xD;
               drug components&#xD;
  &#xD;
           17. Clinically significant, uncontrolled heart disease (including history of any cardiac&#xD;
               arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction&#xD;
               abnormality within 12 months of screening).&#xD;
  &#xD;
           18. Vaccinated with live attenuated vaccines within 4 weeks of the first dose of the study&#xD;
               drug.&#xD;
  &#xD;
           19. Adequate performance status (Karnofsky score ≥ 60 for patients (age ≥ 16), Lansky&#xD;
               score ≥ 60 (age &lt; 16).&#xD;
  &#xD;
           20. The subject has a history of any other illness, which, in the opinion of the&#xD;
               Investigator, might pose an unacceptable risk by administering study medication.&#xD;
  &#xD;
           21. The subject has any current or past medical condition and/or required medication to&#xD;
               treat a condition that could affect the evaluation of the study.&#xD;
  &#xD;
           22. Pregnant females as determined by positive [serum or urine] hCG test at Screening or&#xD;
               prior to dosing. Participants of child-bearing age should use adequate contraception&#xD;
               as defined in the study protocol. (Please refer to section 4.4)&#xD;
  &#xD;
           23. Lactating females&#xD;
  &#xD;
           24. Subjects, who are committed to an institution by virtue of an order issued either by&#xD;
               the judicial or the administrative authorities&#xD;
  &#xD;
           25. The subject is unwilling or unable to follow the procedures outlined in the protocol&#xD;
  &#xD;
           26. The subject is mentally or legally incapacitated.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>3 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Udo Kontny, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Uniklinik RWTH Aachen</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Helena Kerp, PhD</last_name>
      <phone>+49 201 74 94 96 14</phone>
      <email>h.kerp@forschung-paediatrie.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tristan Römer, MD.</last_name>
      <phone>+49 241 80 38063</phone>
      <email>troemer@ukaachen.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Uniklinik RWTH Aachen, Department of Internal Medicine</name>
        <address>
          <city>Aachen</city>
          <zip>52074</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Uniklinik RWTH Aachen, Division of Pediatric Hematology, Oncology, Stem Cell Transplantation</name>
        <address>
          <city>Aachen</city>
          <zip>52074</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Oncology and Hematology, Charité University Medicine Berlin</name>
        <address>
          <city>Berlin</city>
          <zip>13353</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Anne Thorwarth, MD</last_name>
        <phone>+49 30-450-666-488</phone>
        <email>anne.thorwarth@charite.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Evangelisches Klinikum Bethel, Children's Hospital</name>
        <address>
          <city>Bielefeld</city>
          <zip>33617</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Hematology and Oncology, University Hospital</name>
        <address>
          <city>Bonn</city>
          <zip>53127</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Dagmar Dilloo, MD</last_name>
        <phone>+49-228-287-33215</phone>
        <email>dagmar.dilloo@ukbonn.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Children's Hospital, Carl-Thiem Klinikkum Cottbus</name>
        <address>
          <city>Cottbus</city>
          <zip>03048</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Georg Schwabe, MD</last_name>
        <phone>+49-355-46-2336</phone>
        <email>G.Schwabe@ctk.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Clinic for Children and Adolescent Medicine, Klinikum Dortmund</name>
        <address>
          <city>Dortmund</city>
          <zip>44145</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Internal Medicine, Klinikum Dortmund</name>
        <address>
          <city>Dortmund</city>
          <zip>44145</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department fo Radiotherapy, University Hospital</name>
        <address>
          <city>Erlangen</city>
          <zip>91054</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Marlen Haderlein, MD</last_name>
        <phone>+49-9131-8533405</phone>
        <email>st-studiensekretariat@uk-erlangen.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pediatrics, University Hospital Erlangen</name>
        <address>
          <city>Erlangen</city>
          <zip>91054</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Medical Oncology, West German Cancer Center, University Hospital Essen</name>
        <address>
          <city>Essen</city>
          <zip>45147</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Stefan Kasper-Virchow, MD</last_name>
        <phone>+49-201-72384150</phone>
        <email>WTZI-Studie@uk-essen.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Hematology and Oncology, University Hospital Essen</name>
        <address>
          <city>Essen</city>
          <zip>45147</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Stefan Schönberger, MD</last_name>
        <phone>+49-201-723-85190.</phone>
        <email>Stefan.Schoenberger@uk-essen.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pediatrics, University Hospital</name>
        <address>
          <city>Frankfurt</city>
          <zip>60590</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Konrad Bochennek, MD</last_name>
        <phone>+49-69-6301-4157</phone>
        <email>Konrad.Bochennek@kgu.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Hematology/Oncology, University Hospital Freiburg</name>
        <address>
          <city>Freiburg</city>
          <zip>79106</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Simone Hettmer, MD</last_name>
        <phone>+49-761-270-46940</phone>
        <email>simone.hettmer@uniklinik-freiburg.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Oncology, Justus-Liebig University of Giessen</name>
        <address>
          <city>Giessen</city>
          <zip>35392</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Hematology/Oncology, University Medicine Greifswald</name>
        <address>
          <city>Greifswald</city>
          <zip>17475</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Karoline Ehlert, MD</last_name>
        <phone>+49-3834-866325</phone>
        <email>karoline.ehlert@med.uni-greifswald.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Oncology, University Hospital</name>
        <address>
          <city>Göttingen</city>
          <zip>37075</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Christof Kramm, MD</last_name>
        <phone>+49-551-39-63081</phone>
        <email>paedonko@med.uni-goettingen.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitätsklinikum Halle, Klinik für Pädiatrie I</name>
        <address>
          <city>Halle</city>
          <zip>06120</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jessica Höll, MD</last_name>
        <phone>+49-345-557-2388</phone>
        <email>Jessica.Hoell@uk-halle.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Oncology, University Children's Hospital</name>
        <address>
          <city>Hamburg</city>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Otorhinolaryngology, Jena University Hospital</name>
        <address>
          <city>Jena</city>
          <zip>07743</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Oncology, University Hospital Kiel</name>
        <address>
          <city>Kiel</city>
          <zip>24105</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Simon Vieth, MD</last_name>
        <phone>+49-431-500-20119</phone>
        <email>Simon.Vieth@uksh.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Otorhinolaryngology, Head and Neck Surgery, University of Cologne</name>
        <address>
          <city>Köln</city>
          <zip>50937</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jens Klußmann, MD</last_name>
        <phone>+49-221-4784750</phone>
        <email>jens.klussmann@uk-koeln.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Department of Pediatrics, University Hospital Mageburg</name>
        <address>
          <city>Magdeburg</city>
          <zip>39120</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Antje Redlich, MD</last_name>
        <phone>+49-391-67-24235</phone>
        <email>Antje.Redlich@med.ovgu.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Pediatric Hematology/Oncology, University Medicine Mainz</name>
        <address>
          <city>Mainz</city>
          <zip>55131</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim,</name>
        <address>
          <city>Mannheim</city>
          <zip>68167</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Hematology and Oncology, University Children's Hospital</name>
        <address>
          <city>Münster</city>
          <zip>48149</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Hospital</name>
        <address>
          <city>Regensburg</city>
          <zip>93053</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Marcus Jakob, MD</last_name>
        <phone>+49-941-944-2101</phone>
        <email>Marcus.Jakob@klinik.uni-regensburg.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Universitätsklinikum Tübingen, Klinik für Pädiatrie I</name>
        <address>
          <city>Tübingen</city>
          <zip>72076</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Department of Pediatric Hematology, Oncology and Stem Cell Transplantation, University Children's Hospital, University of Würzburg</name>
        <address>
          <city>Würzburg</city>
          <zip>97080</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>RWTH Aachen University</investigator_affiliation>
      <investigator_full_name>Prof. Dr. Udo Kontny</investigator_full_name>
      <investigator_title>Head, Div. Pediatric Hematology, Oncology, Stem Cell Transplantation</investigator_title>
    </responsible_party>
    <keyword>Immunotherapy</keyword>
    <keyword>Nivolumab</keyword>
    <keyword>Children</keyword>
    <keyword>Adults</keyword>
    <keyword>Chemotherapy</keyword>
    <keyword>Immune Checkpoint Inhibitor</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma</mesh_term>
      <mesh_term>Nasopharyngeal Carcinoma</mesh_term>
      <mesh_term>Nasopharyngeal Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Interferons</mesh_term>
      <mesh_term>Interferon-beta</mesh_term>
      <mesh_term>Interferon beta-1a</mesh_term>
      <mesh_term>Cisplatin</mesh_term>
      <mesh_term>Gemcitabine</mesh_term>
      <mesh_term>Fluorouracil</mesh_term>
      <mesh_term>Nivolumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06019130
  org study id: EUCT: 2022-500676-59-00
  nct id: NCT06019130
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to assess whether the addition of the immune checkpoint
        inhibitor Nivolumab to induction chemotherapy will increase the percentage of patients with a
        complete response on MRI and PET after 3 cycles of induction therapy.
  After being informed about the study and potential risks, all patients will undergo a 2-week
        screening period to determine eligibility for study entry. After informed consent has been
        obtained, all patients ≤ 25 years and patients > 25 years without metastases will receive
        Nivolumab (4.5 mg/kg BW (max. 360 mg) q 3 weeks) added to standard induction chemotherapy (3
        blocks of cisplatin/5-fluorouracil). In patients not responding to induction chemotherapy,
        the application of Nivolumab will be extended throughout the period of radiochemotherapy.
  
        Patients > 25 years with metastatic disease will receive Nivolumab (4.5 mg/kg BW (max. 360
        mg) q 3 weeks) added to induction chemotherapy with 3 blocks of cisplatin/gemcitabine.
  
        All patients with metastatic disease will continue to receive Nivolumab during
        radiochemotherapy.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: A phase-II optimum Simon design with alpha=0.1 and beta=0.2 will be used.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Complete remission rate after induction therapy
  time frame: MRI and PET will be done 17-22 days after start of induction therapy cycle 3 (each cycle is 21 days)
  description: Complete response by MRI and PET will be determined as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  measure: Overall and Event-free Survival
  time frame: 2 years after study enrolment
  description: Overall and event-free survival rates will be analysed with suitable descriptive methods (Kaplan Meyer estimates with confidence intervals) and compared with historical data using descriptive log-rank tests
  measure: Number of Treatment-Related Adverse Events
  time frame: At day 0 of chemotherapy cycles 1, 2 and 3, each; at day 20-25 after beginning of chemotherapy cycle 3 (each cycle is 21 days); within 2-3 weeks after the last dose of radiotherapy; 100 days following the last dose of Nivolumab
  description: Adverse events will be classified using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE) version 5.0 by investigator assessment. Descriptive methods (frequency tables, rates of AE's and SAE's with 95% confidence intervals) will be applied
  measure: Efficacy based on PD-L1 expression in tumor tissue
  time frame: Response to induction therapy will be measured 17-22 days after start of induction therapy cycle 3 (each cycle is 21 days), event-free and overall survival will be determined 2 years after study enrolment
  description: PD-L1-stained % of tumor cells at the time of diagnosis will be associated to the rate of response after induction therapy and EFS and OS
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  arm group type: Experimental
  description: Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.
  After induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy in patients with PR or a reduced boost at 54Gy in patients with CR. Cisplatin will be administered at 3x20mg/m2 in the first and last week of radiotherapy, each.
  Radiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU/week s.c. for 6 months.
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group type: Experimental
  description: Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5. Patients with metastases responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab.
  After induction therapy patients will undergo standard radiochemotherapy. Primary PTV1 including elective irradiated LN-levels, will be 45Gy, with a boost ad 59.4Gy. Cisplatin will be administered at 3x20mg/m2 in the first and last week of radiotherapy, each. Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.
  Radiochemotherapy is followed by maintenance therapy with recombinant interferon-ß1a at 3x6Mio IU/week s.c. for 6 months.
  arm group label: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
  arm group type: Experimental
  description: Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.
  After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO).
  arm group label: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
  arm group type: Experimental
  description: Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 100 mg/m2 on day 1, plus 5-fluorouracil 1,000 mg/m2/d from day 1-5.
  After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.
  arm group label: Patients > 25 years with metastatic disease at diagnosis
  arm group type: Experimental
  description: Participants receive Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) during induction chemotherapy for a total of 3 doses, starting on day 1 of cycle 1 of induction standard chemotherapy with cisplatin 80 mg/m2 on day 1, plus gemcitabine 1,000 mg/m2/d on day 1 and day 8, respectively. Patients responding to induction therapy may have a fourth cycle of induction therapy, including a fourth dose of Nivolumab.
  After induction therapy patients will undergo standard radiochemotherapy as outlined in current international guidelines (e.g. NCCN, ESMO). Nivolumab (4.5 mg/kg BW (max. 360 mg) every three weeks) will be continued during radiochemotherapy, adding a total of 3 further doses of Nivolumab.
  intervention type: Drug
  intervention name: Nivolumab
  description: Nivolumab during induction chemotherapy in all groups and during radiochemotherapy in patients with SD or PD after induction or metastases
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  arm group label: Patients > 25 years with metastatic disease at diagnosis
  arm group label: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
  arm group label: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
  other name: Opdivo
  intervention type: Drug
  intervention name: Cisplatin
  description: Cisplatin during induction chemotherapy and during radiochemotherapy in all groups
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  arm group label: Patients > 25 years with metastatic disease at diagnosis
  arm group label: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
  arm group label: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
  other name: Cisplatin Teva
  intervention type: Drug
  intervention name: 5-Fluorouracil
  description: 5-Fluoruracil during induction chemotherapy in all groups except of adults > 25 years with metastatic disease at diagnosis
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  arm group label: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
  arm group label: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
  other name: Fluorouracil-GRY
  intervention type: Drug
  intervention name: Gemcitabine
  description: Gemcitabine during induction chemotherapy in patients > 25 years with metastatic disease at diagnosis
  arm group label: Patients > 25 years with metastatic disease at diagnosis
  other name: Gemcitabin-GRY
  intervention type: Radiation
  intervention name: Radiotherapy
  description: After induction therapy in all patients
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  arm group label: Patients > 25 years with metastatic disease at diagnosis
  arm group label: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
  arm group label: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
  intervention type: Drug
  intervention name: Interferon beta-1a
  description: In patients < 26 years after end of radiochemotherapy for 6 months
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  other name: Rebif
  intervention type: Procedure
  intervention name: MRI
  description: At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  arm group label: Patients > 25 years with metastatic disease at diagnosis
  arm group label: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
  arm group label: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
  intervention type: Procedure
  intervention name: PET
  description: At diagnosis and 17 to 22 days after the beginning of cycle 3 of induction therapy, either as PET-CT or PET-MRI
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  arm group label: Patients > 25 years with metastatic disease at diagnosis
  arm group label: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
  arm group label: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
  intervention type: Behavioral
  intervention name: Patient-Reported Outcomes
  description: For all patients at baseline, before radiochemotherapy, at day 100, and 2 years after enrolment
  arm group label: Patients < 26 y with no metastases and SD or PD after induction therapy or patients with metastases
  arm group label: Patients < 26 years with non-metastatic disease with CR or PR after induction therapy
  arm group label: Patients > 25 years with metastatic disease at diagnosis
  arm group label: Patients > 25 years with non-metastatic disease with SD or PD after induction therapy
  arm group label: Patients >25 years with non-metastatic disease with CR or PR after induction therapy
  criteria: 
  gender: All
  minimum age: 3 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Udo Kontny, MD
  role: Principal Investigator
  affiliation: Uniklinik RWTH Aachen
  last name: Helena Kerp, PhD
  phone: +49 201 74 94 96 14
  email: h.kerp@forschung-paediatrie.de
  last name: Tristan Römer, MD.
  phone: +49 241 80 38063
  email: troemer@ukaachen.de
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: RWTH Aachen University
  investigator full name: Prof. Dr. Udo Kontny
  investigator title: Head, Div. Pediatric Hematology, Oncology, Stem Cell Transplantation
  mesh term: Carcinoma
  mesh term: Nasopharyngeal Carcinoma
  mesh term: Nasopharyngeal Neoplasms
  mesh term: Interferons
  mesh term: Interferon-beta
  mesh term: Interferon beta-1a
  mesh term: Cisplatin
  mesh term: Gemcitabine
  mesh term: Fluorouracil
  mesh term: Nivolumab
  sharing ipd: No