Trials / Recruiting
RecruitingNCT06496178
A Phase 3 Study to Evaluate Petosemtamab Compared With Investigator's Choice Monotherapy in Previously Treated Head and Neck Squamous Cell Carcinoma Patients
A Phase 3 Open-label, Randomized Controlled Study to Evaluate the Efficacy and Safety of Petosemtamab Compared With Investigator's Choice Monotherapy Treatment in Previously Treated Patients With Incurable, Metastatic/Recurrent 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 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.
Detailed description
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. HNSCC patients must have progressive disease (PD) on or after anti-PD-1 therapy and platinum-containing therapy. Patients treated with platinum-containing therapy only in the adjuvant setting, or in the context of multimodal therapy for locally advanced disease, should have PD within 6 months of the last dose of platinum-containing therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Petosemtamab | MCLA-158 |
| DRUG | Investigator's Choice | Cetuximab |
| DRUG | Investigator's Choice | Methotrexate |
| DRUG | Investigator's Choice | Docetaxel |
Timeline
- Start date
- 2024-06-25
- Primary completion
- 2028-02-01
- Completion
- 2029-03-01
- First posted
- 2024-07-11
- Last updated
- 2026-03-31
Locations
208 sites across 24 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
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06496178. Inclusion in this directory is not an endorsement.