NCT06557889View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

October 21, 2024

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2030

Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
DRUG

Pembrolizumab + Cisplatin/Carboplatin + 5-FU

"* 4 cycles of combination treatment: 4 cycles of pembrolizumab (200 mg IV on Day 1 of each 3-week cycle) in combination with chemotherapy with platinum salts (cisplatin (100 mg/m2 IV on Day 1 of each 3-week cycle) or carboplatin (AUC 5 IV on Day 1 of each 3-week cycle), at the investigator's choice) and 5-FU (1000 mg/m2/day IV continuous from Day 1-4 of each 3-week cycle).~* Maintenance phase: pembrolizumab is continued as monotherapy for up to 24 months of treatment in total (from the first injection of cycle 1)."

Trial Locations (13)

Unknown

NOT_YET_RECRUITING

Institut Sainte Catherine, Avignon

RECRUITING

Chu Bordeaux - Hopital Saint André, Bordeaux

NOT_YET_RECRUITING

Centre Jean Perrin, Clermont-Ferrand

NOT_YET_RECRUITING

Centre Oscar Lambret, Lille

RECRUITING

Chu Limoges, Limoges

RECRUITING

Centre Hospitalier Regional de Marseille, Marseille

NOT_YET_RECRUITING

CHU de Nantes, Nantes

RECRUITING

Centre Antoine Lacassagne, Nice

RECRUITING

Chu de Nimes, Nîmes

RECRUITING

CHU Poitiers, Poitiers

NOT_YET_RECRUITING

Centre Eugène Marquis, Rennes

RECRUITING

Clinique Pasteur, Toulouse

RECRUITING

IUCT-O, Toulouse

All Listed Sponsors
lead

Institut Claudius Regaud

OTHER