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 [LiGeR-HN1)

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.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Dr Miles Andrews

Key inclusion data

Histologically confirmed head and neck squamous cell carcinoma with evidence of metastatic or locally recurrent disease not amenable to local therapy with curative intent; The eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx; Patients eligible to receive pembrolizumab as first line monotherapy with tumors expressing PD-L1.