Clinical Trial

A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients (LiGeR-HN2)

Recruiting Phase 3
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Summary
This is a phase 3 open-label, randomized, controlled, multicenter study to compare petosemtamab vs investigator's choice monotherapy in HNSCC patients for the second- and third-line treatment of incurable metastatic/recurrent disease.
Protocol Amendment History 3 changes
critical Primary endpoint(s) modified 2026-05-19
notable Enrollment increased: 500 -> 600 participants 2026-05-19
notable Trial sites expanded: 208 -> 214 locations 2026-05-19
Trial Details
NCT Number NCT06496178
Lead Sponsor Merus B.V.
Conditions Head and Neck Squamous Cell Carcinoma
Enrollment 600 participants
Start Date 2024-06-25
Primary Completion 2028-02 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2026-07-16