drugset
drugset / Trial / NCT06557889

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

NCT06557889 ↗

Phase 2 Recruiting 86 enrolled Institut Claudius Regaud
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-10-21
Primary completion
2030-09
Completion
2030-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule 5 unknown Intravenous
Subject Cisplatin Other / unclassified 100 mg/m2 Intravenous
Subject Pembrolizumab Monoclonal antibody 200 mg Intravenous
Subject fluorouracil Small molecule 1000 mg/m2 Intravenous

Indications

head and neck squamous cell carcinoma