Clinical Trial

A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (LiGeR - HN1)

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
This is 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.
Protocol Amendment History 4 changes
notable Trial sites expanded: 202 -> 205 locations 2026-06-03
notable Trial sites expanded: 197 -> 202 locations 2026-05-09
notable Enrollment increased: 500 -> 700 participants 2026-04-23
notable Trial sites expanded: 191 -> 197 locations 2026-04-23
Trial Details
NCT Number NCT06525220
Lead Sponsor Merus B.V.
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 700 participants
Start Date 2024-09-25
Primary Completion 2028-01 (estimated)
Study Completion 2030-07 (estimated)
Updated on ClinicalTrials.gov 2026-06-02