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) - GORTEC 2018-01

Groupe Oncologie Radiotherapie Tete Cou0 sites674 target enrollmentMay 24, 2024

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Groupe Oncologie Radiotherapie Tete Cou
Enrollment: 674
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 24, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Groupe Oncologie Radiotherapie Tete Cou

Eligibility Criteria

Inclusion Criteria

•Age \> 18 and \< 75 years, Squamous cell carcinoma of the head and neck treated by primary surgery, 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), Subject must have complete macroscopic resection., Subject must be free of disease, Recovery from the surgical procedure allowing for cisplatin\-Radiotherapy, 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, 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., Adequate tumor specimen from archived or resected tissue available for PD\-L1, TILs and immune landscape and other biomarker evaluation, Performance Status (PS) ECOG 0\-1, Written informed consent, Recording of alcohol consumption and smoking history, 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

Exclusion Criteria

•Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers, Incomplete macroscopic resection (R2\), as stated in the surgical report, Squamous cell carcinoma involving cervical neck nodes with unknown primary site, Active central nervous system disease, Interstitial lung disease, Active infection, Metastatic disease, 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, Concurrent treatment with any other systemic anti\-cancer therapy that is not specified in the protocol, 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, 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), 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, 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., 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, 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, 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