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    Summary
    EudraCT Number:2017-004936-13
    Sponsor's Protocol Code Number:GORTEC_2018-01
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2017-004936-13
    A.3Full title of the trial
    A phase III randomized trial of post-operative adjuvant nivolumab and concomitant chemo-radiotherapy in high-risk patients with resected squamous cell carcinoma of head and neck (SCCHN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized trial evaluating the addition of nivolumab to cisplatin-radiotherapy combination for treatment of cancers of the head and neck
    A.3.2Name or abbreviated title of the trial where available
    NIVO POST-OP
    A.4.1Sponsor's protocol code numberGORTEC_2018-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGORTEC
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGORTEC
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportBMS Group
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMahasti Bert/GORTEC
    B.5.2Functional name of contact pointMahasti Bert
    B.5.3 Address:
    B.5.3.1Street Address4B Rue Emile Zola
    B.5.3.2Town/ cityTOURS
    B.5.3.3Post code37000
    B.5.3.4CountryFrance
    B.5.4Telephone number+33623 34 76 07
    B.5.5Fax number+33242 06 01 76
    B.5.6E-mailmahasti.bert@gortec.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OPDIVO
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNIVOLUMAB
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS-936558
    D.3.9.3Other descriptive nameMDX1106, ONO-4538
    D.3.9.4EV Substance CodeSUB122750
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeFully human monoclonal PD-L1 antibody of isotype IgG4
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Squamous cell carcinoma treated by primary surgery
    Stage III, stage IV (American Joint Committee on Cancer 7th edition)
    Oral cavity, oropharynx, hypopharynx or larynx
    E.1.1.1Medical condition in easily understood language
    Locally advanced and post-operative squamous cell carcinoma of the head and neck
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy of nivolumab + cisplatin-RT relative to SOC cisplatin-RT alone, using the disease-free survival (DFS by investigator imaging assessment) as primary endpoint
    E.2.2Secondary objectives of the trial
    - To compare the overall survival (OS), loco-regional control, distant metastases of nivolumab in combination with cisplatin-RT vs SOC cisplatin-RT
    - To determine DFS by blinded independent central review imaging
    - To evaluate DFS and OS by PD-L1 expression
    - To evaluate the overall safety and tolerability profile of nivolumab in combination with cisplatin-RT as compared to SOC cisplatin-RT
    - To evaluate DFS by PDL-1 expression (using 28-8 assay)
    - To evaluate the effect of nivolumab in combination with cisplatin-RT compared to SOC cisplatin-RT on health-related quality of life
    - To evaluate candidate immune-related predictive biomarkers of sensitivity or insensitivity to treatment with nivolumab in pre-treatment tumor samples obtained at surgery and in blood (levels of cells, DNA, RNA, or proteins that may be related to antitumor immune response and/or disease
    progression) and to explore potential correlations between treatment outcome and the immune landscape.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > 18 and < 75 years
    2. Performance Status (PS) ECOG 0-1 (Appendix 2)
    3. Written informed consent
    4. Recording of alcohol consumption and smoking history
    5. Histologically proven squamous cell carcinoma of the head and neck from one or more of the following primary sites: oral cavity, oropharynx, hypopharynx or larynx
    6. Squamous cell carcinoma of the head and neck treated by primary surgery
    7. Histopathological classification: pStage III or IV. However, Oropharyngeal Cancer pStage II p16 positive with pT3N1 or pT4N1 and tobacco consumption ≥20 packs/year are eligible. (American Joint Committee on Cancer 8th edition) 38
    8. Subject must have complete macroscopic resection.
    9. Subject must be free of disease
    10. Recovery from the surgical procedure allowing for cisplatin-Radiotherapy
    11. Radiotherapy planned to start within 4 to 9 weeks after surgery. However, a maximum of 1 additional week could be considered in case of delay due to healing or logistical problem
    12. Patient/tumor carrying a high risk of relapse with one or more following criteria:
    - Extra-capsular extension (ECE)
    - Multiple peri-neural invasion
    - Multiple nodal extension without ECE (≥ 4 nodes)
    - Positive margins (R1 or close margin ≤ 1 mm)
    R1 is microscopic residual disease and close margin is R0 with a minimum margin ≤ 1 mm in any direction.
    13. Adequate tumor specimen from archived or resected tissue available for PD-L1, TILs and immune landscape and other biomarker evaluation
    14. For oropharyngeal tumor, known p16 status (by Immunohistochemistry method)
    15. Determination of patient ability to receive cisplatin 100 mg/m2 for 3 cycles:
    - Creatinine Clearance (CrCl) ≥ 60 mL/min (measured or calculated by Cockcroft and Gault method) or estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73m2 (determined by CKD-EPI or MDRD method). The highest value should be considered if both are assessed.
    - Absolute neutrophil count ≥1 500/mm3, platelets ≥100 000/mm3, haemoglobin ≥ 9 g/dL, aspartate transaminase (AST) and alanine transaminase (ALT) less than 2.5 times the upper limit of the normal range (ULN), total bilirubin ≤ 1.5 mg/dL(except Gilbert Syndrom: < 3.0 mg/dL).
    - Peripheral neuropathy ≤ grade 2
    - No hearing loss (assessed clinically and confirmed by audiogram if doubtful)
    - Cardiac function compatible with hyperhydration
    - No administration of prophylactic phenytoin
    - Patients aged 71-74 years, must be fit according to geriatric evaluation
    E.4Principal exclusion criteria
    1. Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers
    2. Squamous cell carcinoma involving cervical neck nodes with unknown primary site
    3. Metastatic disease
    4. Incomplete macroscopic resection (R2), as stated in the surgical report
    5. Known active viral infection (Human Immunodeficiency Virus (HIV), Hepatitis B/C) or known history of positive test for HIV, active autoimmune disease and/or active immunodeficiency or ongoing immunosuppressive therapy
    6. Active central nervous system disease
    7. Interstitial lung disease
    8. Active infection
    9. Any prior treatment for the current head and neck cancer other than primary surgery. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior RT, or use of any investigational agent
    10. Concurrent treatment with any other systemic anti-cancer therapy that is not specified in the protocol
    11. Concomitant treatment with any drug on the prohibited medication list such as live vaccines. Live vaccines administered more than 30 days before study entry are permitted
    12. History of other malignancy within the last 3 years (exception of in situ carcinoma, thyroid papillary carcinoma, skin carcinomas, localized prostate carcinoma Gleason 6 and in situ breast carcinoma)
    13. Pregnant, breastfeeding patients, and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in the protocol for the duration of the study and for at least 6 months after the last dose of cisplatin and 5 months after the last dose of nivolumab
    14. Male patients who are unwilling or unable to use contraception methods for the duration of the study and for at least 6 months after the last dose of cisplatin
    15. Severe acute or chronic medical conditions including colitis, pneumonitis, pulmonary fibrosis, laboratory abnormalities or other significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial
    16. Known hypersensitivity to study drugs
    17. Prior organ transplantation including allogenic stem-cell transplantation
    18. Clinically significant (i.e., active) cardiovascular disease:
    - Cerebral vascular accident/stroke (< 6 months prior to enrollment) or
    - Myocardial infarction (< 6 months prior to enrollment) or
    - unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II) or
    - Serious cardiac arrhythmia requiring medication
    19. Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment
    20. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
    21. Any psychiatric condition (including active suicidal ideation), or psychological, or familial, or sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
    22. Individuals deprived of liberty or placed under the authority of a tutor.
    E.5 End points
    E.5.1Primary end point(s)
    Disease free survival (DFS by investigator imaging assessments)
    E.5.1.1Timepoint(s) of evaluation of this end point
    the time between the date of randomization and the date of first loco-regional or distant recurrence or death (of any cause) whichever occurs first.
    E.5.2Secondary end point(s)
    - Overall survival
    - DFS by blinded independent central review
    - DFS and OS by PDL-1 status
    - Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure and cumulative incidence of death without previous progression
    - Incidence of second primary malignancy (SCC to a distance >= 3 cm from the tumor bed and that will clearly not be attributable to a relapse or a second cancer arising outside the upper aero digestive track).
    - Safety: Adverse events and laboratory abnormalities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0). Incidence of delayed toxicity of radiotherapy (e.g. dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes).
    - Correlation between the immune landscape and patients’ outcome
    - Patient-Reported Outcomes (PRO): Health related quality of ife (QoL) survey will be assessed by EORTC QLQ-C30, H&N35 and EQ- 5D-5L questionnaires.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During treatment
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Control group will only undergo standard cisplatin-radiotherapy(without nivolumab)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA97
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    Belgium
    Greece
    Netherlands
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 590
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state75
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 660
    F.4.2.2In the whole clinical trial 680
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    According to local standards at investigator choice
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-10-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-19
    P. End of Trial
    P.End of Trial StatusOngoing
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