Trials / Recruiting
RecruitingNCT06525220
A Phase 3 Study to Evaluate Petosemtamab Plus Pembrolizumab vs Pembrolizumab in First-line Treatment of Head and Neck Cancer (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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Merus B.V. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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+ HNSCC. HNSCC patients should not have had previous systemic therapy administered in the incurable recurrent or metastatic setting, although previous systemic therapy as part of multimodal treatment for locally advanced disease is allowed if PD was ≥6 months after the last platinum-containing therapy dose. Previous treatments with anti PD-(L)1 or anti-EGFR therapies are not allowed. In the case of cetuximab, patients who have received cetuximab with radiotherapy as a local treatment and PD was \>1 year after the last dose of cetuximab are eligible.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Petosemtamab | MCLA-158 |
| DRUG | Pembrolizumab | Humanized Antibody |
Timeline
- Start date
- 2024-09-25
- Primary completion
- 2028-01-01
- Completion
- 2030-07-01
- First posted
- 2024-07-29
- Last updated
- 2026-03-27
Locations
191 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Hungary, Israel, Italy, Japan, Lithuania, Malaysia, Netherlands, Poland, Portugal, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06525220. Inclusion in this directory is not an endorsement.