ENT/Head and Neck Cancers

MCLA-158-CL03/LiGeR-HN1

A phase 3 randomized, open-label study to evaluate the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab in first-line treatment of recurrent or metastatic PD-L1+ head and neck squamous cell carcinoma.

Open at Paris since : 27/03/2025
Target : Adult
Phase : Phase III

Trial description

To compare OS in the 1L setting of incurable metastatic/recurrent HNSCC patients eligible for pembrolizumab monotherapy with tumors expressing programmed cell death protein ligand 1 (PD-L1) (combined positive score [CPS]=1), treated with petosemtamab in combination with pembrolizumab vs pembrolizumab alone;À;OS;À;To compare ORR per Response Evaluation Criteria in Solid Tumor (RECIST) Guidelines version (v) 1.1 as assessed by blinded independent central review (BICR) in the 1L setting of incurable metastatic/recurrent HNSCC patients eligible for pembrolizumab monotherapy with tumors expressing PD-L1 (CPS=1), treated with petosemtamab in combination with pembrolizumab vs pembrolizumab alone.

Url of the trial

Main investigator

CHRISTOPHE LE TOURNEAU

Professeur - Médecin

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