Reduction in the Number of Chemotherapy Cycles in Combination With Pembrolizumab in First-line Treatment of PD-L1-positive Recurrent or Metastatic Head and Neck Squamous Cell Carcinomas
NCT Number: NCT06557889
Acronym: REDUCE
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Squamous Cell Carcinoma of Head and Neck
Interventions: DRUG: Once the patient is included in the study, he will receive the treatment schema as defined below:
Sponsor: Institut Claudius Regaud
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 86
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2030-09
Locations: Chu Bordeaux - Hopital Saint André, Bordeaux, France|Chu Limoges, Limoges, France|Centre Hospitalier Regional de Marseille, Marseille, France|Centre Antoine Lacassagne, Nice, France|Chu de Nimes, Nimes, France|Clinique Pasteur, Toulouse, France|IUCT-O, Toulouse, France

Summary:
This is a phase II, prospective, non-randomized, single-arm, multicentric study to evaluate the activity and safety of treatment with 4 cycles (instead of 6) of chemotherapy (platinum (cisplatin or carboplatin) and 5-Fluorouracil) in combination with pembrolizumab for the first-line treatment of CPS PD-L1 positive recurrent or metastatic head and neck squamous cell carcinoma.

A total of 86 patients will have to be enrolled in this study.

Primary Outcome Measures: The endpoint for the activity is defined by the objective response (i.e. complete or partial response) according to the RECIST v1.1 criteria, assessed by the investigator., The objective response rate is defined as the ratio of the number of patients with an objective response to the total number of patients., 48 months for each patient|The endpoint for the safety is defined as the rate of patients with AE leading to all treatment discontinuation., This rate is defined as the ratio of the number of patients with AE leading to all treatment discontinuation to the total number of patients., 24 months for each patient
Secondary Outcome Measures: The objective response rate at 6 months is defined by the presence of an objective response (i.e. complete or partial response) at 6 months according to the RECIST v1.1 criteria, assessed by the investigator., It is defined by the ratio of the number of patients presenting an objective response at 6 months to the total number of patients., 6 months for each patient|Progression-free survival is defined by the time between the date of inclusion and the date on which a first tumor confirmed progression is documented (according to RECIST v1.1 criteria, (Eisenhauer, 2009)) or death from any causes., Patients alive and progression free on the date of last news will be censored on the date of last tumor assessment., 48 months for each patient|Overall survival is defined by the time between the date of inclusion and the date of death from any cause or the date of the last news (Censored Data)., 48 months for each patient|Duration of response is defined in the population of patients with an objective response., It is defined by the time between the date of confirmed objective response and the date on which a first confirmed tumor progression is documented (according to RECIST v1.1 criteria, Eisenhauer, 2009) or death from all causes. Patients alive and progression free at last news will be censored on the date of last tumor assessment., 48 months for each patient|Safety will be assessed according to the toxicity grading of NCI CTCAE v 5.0., 48 months for each patient