AVELUMAB for Squamous cell carcinoma of head and neck

Inclusion criteria

• {"criterion_text":"- Age > 18 years and ≤ 80 years\n- Performance Status ECOG 0-1\n- Histologically confirmed squamous cell carcinoma, previously untreated\n- Stage III, stage IVa (i.e. operable, but not operated) or IVb (non resectable)\n- Oral cavity, oropharynx, hypopharynx or larynx\n- Determination of the patient’s ability to receive cisplatin 100 mg/m2 for 3 cycles (fit / unfit)** Criteria for determining if a patient is fit for receiving high dose cisplatin: - Calculated creatinine clearance ≥ 60 mL/min or glomerular filtration rate ≥ 60 mL/min/1.73m² (CKD-EPI method recommended), - Absolute neutrophil count ≥1 500/μL, platelets ≥100 000/μL, haemoglobin ≥ 10 g/dL, aspartate (AST) and alanine transaminase (ALT) less than 2 times the upper limit of the normal range (ULN), total bilirubin ≤ 1.5 mg/dL, serum albumin ≥ 35 g/L. - Peripheral neuropathy < grade 2 - No sensorineural hearing loss (confirmed by audiogram) - Cardiac function compatible with hyperhydration with no significant heart disease - No administration of prophylactic phenytoin - Age < 75 years. For patients aged 71-74 years, PS must be 0 and fit according to geriatric evaluation - General clinical state compatible with high dose cisplatin and radiotherapy according to the investigator"}

Exclusion criteria

• {"criterion_text":"- Nasopharyngeal, paranasal sinuses, nasal cavity tumours or thyroid cancers\n- Concomitant treatment with any drug on the prohibited medication list such as live vaccines or systemic corticoids at dose > 10 mg/day prednisone or equivalent. Live vaccines administered more than 30 days before study entry are permitted.\n- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication.\n- Squamous cell carcinoma involving cervical neck nodes with unknown primary site\n- Metastatic disease (stage IVc)\n- Active viral infection (HIV, Hepatitis B/C) or known history of positive test for HIV\n- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent\n- Active immunodeficiency or ongoing immunosuppressive therapy\n- Interstitial lung disease\n- Active infection\n- Any prior or current treatment for invasive head and neck cancer. This will include but is not limited to: prior tyrosine kinase inhibitors, any monoclonal antibody, induction chemotherapy, prior surgical resection or RT, or use of any investigational agent. Minor surgery in the head and neck area (e.i. dental extraction diagnostic biopsy) are authorized if performed more than 1 week before study entry and under condition of wound healing."}

Primary endpoints

• {"endpoint_text":"- PFS defined as the time between randomization and the first event among progression (per radiologico-pathological combined Head & Neck cancer assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 (see Appendix) and death, whatever the cause of death","definition_or_measurement_approach":"PFS defined as time between randomization and first event among progression assessed by radiologic-pathologic combined Head & Neck cancer assessment using RECIST v1.1 and death (any cause)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival","definition_or_measurement_approach":""}
• {"endpoint_text":"- Cumulative incidence of locoregional failure, cumulative incidence of distant metastatic failure by Investigator assessment (Appendix 3) and cumulative incidence of death without previous progression","definition_or_measurement_approach":"Investigator assessment (see Appendix 3) for locoregional and distant metastatic failure; cumulative incidence calculations; includes cumulative incidence of death without prior progression."}
• {"endpoint_text":"- Safety: Acute adverse events and laboratory abnormalities as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v4.03. Incidence of delayed toxicity (e.g.; dysphagia, chronic swallowing dysfunctions, speech problems, cervical fibrosis, rate and duration of the use of feeding tubes);","definition_or_measurement_approach":"Adverse events and lab abnormalities graded by NCI CTCAE v4.03; incidence of specified delayed toxicities tracked and reported."}
• {"endpoint_text":"- Patient-Reported Outcomes: Health related quality of life (QL) assessed by EORTC QLQC30 and H&N35 questionnaires","definition_or_measurement_approach":"Health-related quality of life measured using EORTC QLQ-C30 and H&N35 questionnaires."}
• {"endpoint_text":"- Progression Free Survival 2 (PFS2) defined as the time from randomization to progression on subsequent treatment for logoregional relapse, distant metastasis or detah from any cause","definition_or_measurement_approach":"PFS2 defined as time from randomization to progression on subsequent therapy for locoregional relapse or distant metastasis, or death from any cause."}

France

Earliest CTIS Part Ii Submission Date

24-07-2024

Latest Decision Or Authorization Date

16-01-2026

Processing Time Days

541

Number Of Participants

706

Primary sponsor

Full Name

Groupe Oncologie Radiotherapie Tete Cou

Organisation Type

Patient organisation/association

Country Of Registered Address

France