<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/NCT03838263</url>
  </required_header>
  <id_info>
    <org_study_id>UC-0130/1804</org_study_id>
    <secondary_id>2018-000626-60</secondary_id>
    <nct_id>NCT03838263</nct_id>
  </id_info>
  <brief_title>Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer</brief_title>
  <acronym>IMMUNEBOOST</acronym>
  <official_title>A Multicenter, Randomized, Open Label, Phase II Study Evaluating the Feasibility and Tolerance of Nivolumab Neoadjuvant Immunotherapy in High Risk HPV Driven Oropharynx Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNICANCER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNICANCER</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this research is to study the feasibility of neoadjuvant treatment before&#xD;
      chemoradiation in &quot;high risk&quot; HPV-driven Oropharynx cancer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodology:&#xD;
&#xD;
      Patient screened wil be randomized 2:1 between 2 arms:&#xD;
&#xD;
        -  Experimental arm: Nivolumab 2 infusions (2 weeks part) before standard of care&#xD;
           chemoradiation for 7 weeks with cisplatin at week 1, 4, and 7&#xD;
&#xD;
        -  Control arm: Standard of care chemoradiation for 7 weeks with cisplatin at week 1, 4,&#xD;
           and 7&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To assess the feasibility and tolerance of neoadjuvant nivolumab treatment before&#xD;
      chemoradiation in &quot;high-risk&quot; HPV-driven Oropharynx Cancer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 25, 2019</start_date>
  <completion_date type="Anticipated">May 2025</completion_date>
  <primary_completion_date type="Actual">April 1, 2022</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>In this study, there are 2 arms:&#xD;
Experimental arm with nivolumab 2 infusions (2 weeks apart) before Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7&#xD;
Control arm: Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The rate of patients that fulfill the 3 or 5 conditions as described below (Feasibility assessment of nivolumab neoadjuvant treatment before chemoradiation)</measure>
    <time_frame>Between baseline and until 3 months (at the end of chemoradiation)</time_frame>
    <description>the rate of patients :&#xD;
(1) who can receive the 2 nivolumab infusions planned at D1 and between D14 to D16 among patients in the experimental arm And (2) who can receive chemoradiation at D30 (-2 /+7) after the second nivolumab infusion, without delay of more than 7 days with respect to the planned start of chemoradiation (RT-CT) among patients in the experimental arm And (3) with no radiotherapy break of one week or more, among patients in the experimental arm and patients in the control arm separately And (4) with minimal dose of radiotherapy (dose received &gt;95% of theoretical dose) among patients in the experimental arm and patients in the control arm separately And (5) with minimal dose of chemotherapy of ≥200 mg/m² of cisplatin (CDDP) among patients in the experimental arm and patients in the control arm separately</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of Adverse Events related or not related to chemoradiation and Nivolumab</measure>
    <time_frame>During treatment phase and until 90 days after the last fraction of radiotherapy</time_frame>
    <description>Acute and delayed toxicities assessed according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate in the experimental arm</measure>
    <time_frame>Between baseline and up to 17 days after the second infusion of nivolumab</time_frame>
    <description>Radiological response will be assessed according to RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor Response in both arms</measure>
    <time_frame>Between baseline and 3 months after the end of chemoradiation</time_frame>
    <description>Radiological response will be assessed according to RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Between baseline and 2 years after the end of chemoradiation</time_frame>
    <description>the time from randomization to death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Locoregional control (LRC)</measure>
    <time_frame>Between baseline and 2 years after the end of chemoradiation</time_frame>
    <description>the absence of disease progression (radiological progression according to RECIST 1.1 or clinical progression) or recurrence at the site of the primary tumor and loco-regional lymph nodes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Between baseline and 2 years after the end of chemoradiation</time_frame>
    <description>The time from randomization to progression or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate in the experimental arm</measure>
    <time_frame>Between baseline and up to 17 days after the second infusion of nivolumab</time_frame>
    <description>Standardized uptake value (SUV) evolution will be assessed by positron emission tomography (PET)-scan.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumor Response in both arms</measure>
    <time_frame>Between baseline and 3 months after the end of chemoradiation</time_frame>
    <description>SUV evolution will be assessed by PET-scan.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Oropharynx Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental arm with nivolumab 2 infusions (2 weeks apart) before Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control arm: Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>2 nivolumab infusion (240 mg IV) 2 weeks apart (on day 1 and day 15) followed by standard chemoradiation.</description>
    <arm_group_label>Experimental arm</arm_group_label>
    <other_name>ANY</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Chemoradiation</intervention_name>
    <description>Standard of Care chemoradiation for 7 weeks (70 Gray delivered to the tumor by IMRT) with high-dose cisplatin (100mg/m2) at week 1, 4 and 7</description>
    <arm_group_label>Control arm</arm_group_label>
    <arm_group_label>Experimental arm</arm_group_label>
    <other_name>Radiation + cisplatin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years old&#xD;
&#xD;
          2. Histologically confirmed HPV-positive Oropharyngeal squamous cell carcinoma (OPSCC)&#xD;
             amenable to curative treatment with RT-CT (HPV status is defined on the basis of the&#xD;
             combination of 2 assays: p16 protein overexpression assessed by immunohistochemistry&#xD;
             (IHC) and high-risk HPV DNA identification by in-situ Hybridization (ISH) or PCR. An&#xD;
             HPV-driven OPSCC is defined as a tumor that is positive for both p16 IHC and HPV-DNA&#xD;
             ISH or PCR)&#xD;
&#xD;
          3. According to the 8th TNM edition, eligible stages are as follow:&#xD;
&#xD;
               -  Irrespective of tobacco consumption: Stage T4 (any N), N2 or N3 (any T)&#xD;
&#xD;
               -  Only if tobacco consumption ≥10 pack- years: T1-3N1 and T3N0 (T1N0 and T2N0&#xD;
                  irrespective of tobacco consumption are not eligible for the study)&#xD;
&#xD;
          4. Planned date of chemoradiation allowing 2 treatment infusions, 2 weeks apart&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status ≤1&#xD;
&#xD;
          6. Screening laboratory values must meet the following criteria (using CTCAE v5.0) and&#xD;
             should be obtained within 7 days prior to the randomisation:&#xD;
&#xD;
               1. Polynuclear neutrophils ≥1.5 x 10⁹/L&#xD;
&#xD;
               2. Platelets ≥100 x 10⁹/L&#xD;
&#xD;
               3. Hemoglobin ≥9.0 g/dL&#xD;
&#xD;
               4. Alanine aminotransferase (ALAT)/aspartate transaminase (ASAT) ≤2.5 x upper limit&#xD;
                  of normal (ULN)&#xD;
&#xD;
               5. Total Bilirubin ≤1.5 x ULN (except Gilbert Syndrome : &lt;3.0 mg/dL)&#xD;
&#xD;
               6. Creatinine clearance ≥60 mL/min (measured or calculated by Cockcroft and Gault&#xD;
                  formula)&#xD;
&#xD;
          7. Potentially reproductive patients must agree to use a highly effective contraceptive&#xD;
             method while on treatment and up to 6 months after the end of chemoradiation&#xD;
&#xD;
          8. Women of childbearing potential must have a negative serum or urine pregnancy test&#xD;
             done within 72 hours before randomisation&#xD;
&#xD;
          9. Patients must be willing and able to comply with scheduled visits, treatment plan,&#xD;
             laboratory tests and other study procedures (including mandatory study-specific&#xD;
             biopsies)&#xD;
&#xD;
         10. Subjects must have at least one lesion amenable to biopsy&#xD;
&#xD;
         11. Subjects must have at least one measurable lesion (different from the lesion amenable&#xD;
             to biopsy) as per RECIST v1.1 to assess efficacy&#xD;
&#xD;
         12. Consent to provide archived tumour tissue sample, if available&#xD;
&#xD;
         13. Patients must be affiliated to a Social Security System&#xD;
&#xD;
         14. Patient information and written informed consent form signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior treatment for OPSCC&#xD;
&#xD;
          2. Prior treatment with anti PD-1/PD-L1 and CTLA-4&#xD;
&#xD;
          3. Distant metastases&#xD;
&#xD;
          4. Tumour embolization within 28 days prior to the first dose of study drug.&#xD;
&#xD;
          5. Contra-indication(s) to receive high-dose cisplatin as listed in the most updated&#xD;
             Summary of Product Characteristics (including creatinine clearance &lt;60 mL/min,&#xD;
             pre-existing hearing loss or neurological disorder)&#xD;
&#xD;
          6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable&#xD;
             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or&#xD;
             psychiatric illness and social situations that would limit compliance with study&#xD;
             requirement or compromise the ability of the subject to give written informed consent&#xD;
&#xD;
          7. Current or prior use of immunosuppressive medication within 14 days before the first&#xD;
             dose, including intranasal and inhaled corticosteroids or systemic corticosteroids&#xD;
&#xD;
          8. Active or prior documented autoimmune or inflammatory disease within the 2 years prior&#xD;
             to start of treatment (including inflammatory bowel disease [e.g., ulcerative colitis,&#xD;
             Crohn's disease], celiac disease, irritable bowel disease, or other serious chronic&#xD;
             gastrointestinal conditions associated with diarrhea; systemic lupus erythematosus;&#xD;
             Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves'&#xD;
             disease; rheumatoid arthritis; hypophysitis, uveitis, etc.) The following are&#xD;
             exceptions to these criteria:a) Subjects with vitiligo or alopecia, b) Subjects with&#xD;
             hypothyroidism (e.g.,Hashimoto syndrome) stable on hormone replacement and c) Subjects&#xD;
             with psoriasis not requiring systemic treatment (within the past 2 years)&#xD;
&#xD;
          9. History of primary immunodeficiency or organ transplant requiring immunosuppressive&#xD;
             drugs&#xD;
&#xD;
         10. Patients with a known HIV, active hepatitis B or C infection&#xD;
&#xD;
         11. Other invasive malignancy within 3 years except for noninvasive malignancies such as&#xD;
             cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma&#xD;
             in situ of the breast that has/have been surgically cured&#xD;
&#xD;
         12. Pregnant women or women who are breast-feeding&#xD;
&#xD;
         13. Patients with any psychological, familial, sociological or geographical condition&#xD;
             potentially hampering compliance with the study protocol and follow-up schedule; those&#xD;
             conditions should be discussed with the patient before registration in the study&#xD;
&#xD;
         14. Individuals deprived of liberty or placed under the authority of a tutor&#xD;
&#xD;
         15. Severe infection requiring parenteral antibiotics treatment&#xD;
&#xD;
         16. Known history or active symptomatic interstitial lung disease&#xD;
&#xD;
         17. Patients with major surgery within 28 days, or open biopsy within 7 days, prior to&#xD;
             randomisation. Patients must have recovered from major side effects of the surgery&#xD;
             before randomisation&#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>Haïtham MIRGHANI, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HOPITAL EUROPEEN GEORGES POMPIDOU</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut Sainte Catherine</name>
      <address>
        <city>Avignon</city>
        <zip>84918</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Beaujon</name>
      <address>
        <city>Clichy</city>
        <zip>92100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Léon Bérard</name>
      <address>
        <city>Lyon</city>
        <zip>69373</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Antoine Lacassagne</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Europeen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75970</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Henri Becquerel</name>
      <address>
        <city>Rouen</city>
        <zip>76038</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92150</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de cancerologie de Lorraine Alexis Vautrin</name>
      <address>
        <city>Vandoeuvre-Les-Nancy</city>
        <zip>54519</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Gustave Roussy</name>
      <address>
        <city>Villejuif</city>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>February 6, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nivolumab</keyword>
  <keyword>High-risk</keyword>
  <keyword>HPV-driven oropharynx cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Oropharyngeal Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.</ipd_time_frame>
    <ipd_access_criteria>Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.</ipd_access_criteria>
  </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/NCT03838263
org study id: UC-0130/1804
secondary id: 2018-000626-60
nct id: NCT03838263
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this research is to study the feasibility of neoadjuvant treatment before
      chemoradiation in "high risk" HPV-driven Oropharynx cancer
Methodology:

      Patient screened wil be randomized 2:1 between 2 arms:

        -  Experimental arm: Nivolumab 2 infusions (2 weeks part) before standard of care
           chemoradiation for 7 weeks with cisplatin at week 1, 4, and 7

        -  Control arm: Standard of care chemoradiation for 7 weeks with cisplatin at week 1, 4,
           and 7

      Primary Objective:

      To assess the feasibility and tolerance of neoadjuvant nivolumab treatment before
      chemoradiation in "high-risk" HPV-driven Oropharynx Cancer
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, there are 2 arms:
Experimental arm with nivolumab 2 infusions (2 weeks apart) before Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7
Control arm: Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7
primary purpose: Treatment
masking: None (Open Label)
measure: The rate of patients that fulfill the 3 or 5 conditions as described below (Feasibility assessment of nivolumab neoadjuvant treatment before chemoradiation)
time frame: Between baseline and until 3 months (at the end of chemoradiation)
description: the rate of patients :
(1) who can receive the 2 nivolumab infusions planned at D1 and between D14 to D16 among patients in the experimental arm And (2) who can receive chemoradiation at D30 (-2 /+7) after the second nivolumab infusion, without delay of more than 7 days with respect to the planned start of chemoradiation (RT-CT) among patients in the experimental arm And (3) with no radiotherapy break of one week or more, among patients in the experimental arm and patients in the control arm separately And (4) with minimal dose of radiotherapy (dose received >95% of theoretical dose) among patients in the experimental arm and patients in the control arm separately And (5) with minimal dose of chemotherapy of ≥200 mg/m² of cisplatin (CDDP) among patients in the experimental arm and patients in the control arm separately
measure: The incidence of Adverse Events related or not related to chemoradiation and Nivolumab
time frame: During treatment phase and until 90 days after the last fraction of radiotherapy
description: Acute and delayed toxicities assessed according to national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0
measure: Objective Response Rate in the experimental arm
time frame: Between baseline and up to 17 days after the second infusion of nivolumab
description: Radiological response will be assessed according to RECIST 1.1.
measure: Tumor Response in both arms
time frame: Between baseline and 3 months after the end of chemoradiation
description: Radiological response will be assessed according to RECIST 1.1.
measure: Overall Survival (OS)
time frame: Between baseline and 2 years after the end of chemoradiation
description: the time from randomization to death from any cause
measure: Locoregional control (LRC)
time frame: Between baseline and 2 years after the end of chemoradiation
description: the absence of disease progression (radiological progression according to RECIST 1.1 or clinical progression) or recurrence at the site of the primary tumor and loco-regional lymph nodes.
measure: Progression-Free Survival (PFS)
time frame: Between baseline and 2 years after the end of chemoradiation
description: The time from randomization to progression or death from any cause
measure: Objective Response Rate in the experimental arm
time frame: Between baseline and up to 17 days after the second infusion of nivolumab
description: Standardized uptake value (SUV) evolution will be assessed by positron emission tomography (PET)-scan.
measure: Tumor Response in both arms
time frame: Between baseline and 3 months after the end of chemoradiation
description: SUV evolution will be assessed by PET-scan.
arm group label: Experimental arm
arm group type: Experimental
description: Experimental arm with nivolumab 2 infusions (2 weeks apart) before Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7
arm group label: Control arm
arm group type: Active Comparator
description: Control arm: Standard of care chemoradiation for 7 weeks with high-dose cisplatin (100 mg/m²) at week 1, 4 and 7
intervention type: Drug
intervention name: Nivolumab
description: 2 nivolumab infusion (240 mg IV) 2 weeks apart (on day 1 and day 15) followed by standard chemoradiation.
arm group label: Experimental arm
other name: ANY
intervention type: Radiation
intervention name: Chemoradiation
description: Standard of Care chemoradiation for 7 weeks (70 Gray delivered to the tumor by IMRT) with high-dose cisplatin (100mg/m2) at week 1, 4 and 7
arm group label: Control arm
arm group label: Experimental arm
other name: Radiation + cisplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Haïtham MIRGHANI, MD, PhD
role: Principal Investigator
affiliation: HOPITAL EUROPEEN GEORGES POMPIDOU
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Oropharyngeal Neoplasms
mesh term: Cisplatin
mesh term: Nivolumab
sharing ipd: Yes
ipd description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
ipd access criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.