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

Detailed criteria

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

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.

Locations (211)

University of Arizona
Tucson, Arizona
tkatz@arizona.edu 520-621-2029
University of California - San Diego
La Jolla, California
croneil@health.ucsd.edu 858-822-6575
The Angeles Clinic and Research Institute- West Los Angeles
Los Angeles, California
SMukarram@theangelesclinic.org 310-231-2181
ESC Norris Comprehensive Cancer Center
Los Angeles, California
Sandy.tran@med.usc.edu 323-865-3935
UCLA Hematology/Oncology
Los Angeles, California
JCrocker@mednet.ucla.edu 310-794-3266
Stanford Cancer Institute - Stanford Cancer Center Palo Alto
Palo Alto, California