Trials / Recruiting
RecruitingNCT06112314
IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
A Phase 3 Randomized, Controlled Study of IMC-F106C Plus Nivolumab Versus Nivolumab Regimens in HLA-A*02:01-Positive Participants With Previously Untreated Advanced Melanoma (PRISM-MEL-301
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 680 (estimated)
- Sponsor
- Immunocore Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase 3, randomized, controlled study of brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A\*02:01-positive participants with previously untreated advanced melanoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brenetafusp | Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL. |
| DRUG | Nivolumab | Concentrate for solution for infusion at a unit dose of 10 mg/mL. |
| DRUG | Nivolumab + Relatlimab | Concentrate for solution for infusion at a unit dose of 16 mg/mL. |
Timeline
- Start date
- 2024-06-05
- Primary completion
- 2027-10-16
- Completion
- 2027-10-16
- First posted
- 2023-11-01
- Last updated
- 2026-02-25
Locations
211 sites across 26 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Lithuania, Mexico, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06112314. Inclusion in this directory is not an endorsement.