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)
NCT06496178 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600
Last updated 2026-05-18
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.
Conditions
Interventions
- DRUG
-
Petosemtamab
MCLA-158
- DRUG
-
Investigator's Choice
Cetuximab
- DRUG
-
Investigator's Choice
Methotrexate
- DRUG
-
Investigator's Choice
Docetaxel
Sponsors & Collaborators
-
Merus B.V.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-25
- Primary Completion
- 2028-02-29
- Completion
- 2029-03-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- Canada
- Chile
- Czechia
- France
- Germany
- Greece
- Hungary
- Israel
- Italy
- Japan
- Lithuania
- Netherlands
- Poland
- Portugal
- South Korea
- Spain
- Switzerland
- Taiwan
- United Kingdom
Study Locations
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