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
Immunocore Ltd
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be HLA-A\*02:01-positive * Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma * Archived or fresh tumor tissue sample that must be confirmed as adequate * Participants must have measurable disease per RECIST 1.1 * Participant must have BRAF V600 mutation status determined * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effe…
Interventions
- DrugBrenetafusp
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.
- DrugNivolumab
Concentrate for solution for infusion at a unit dose of 10 mg/mL.
- DrugNivolumab + Relatlimab
Concentrate for solution for infusion at a unit dose of 16 mg/mL.
Locations (211)
- University of ArizonaTucson, Arizona
- University of California - San DiegoLa Jolla, California
- The Angeles Clinic and Research Institute- West Los AngelesLos Angeles, California
- ESC Norris Comprehensive Cancer CenterLos Angeles, California
- UCLA Hematology/OncologyLos Angeles, California
- Stanford Cancer Institute - Stanford Cancer Center Palo AltoPalo Alto, California