drugset / Trial / NCT06112314

IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)

NCT06112314

Phase 3 Recruiting 680 enrolled Immunocore Ltd
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-06-05
Primary completion
2027-10-16
Completion
2027-10-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Brenetafusp Protein / enzyme biologic Intravenous
Subject Nivolumab Monoclonal antibody 480 mg
Comparator Relatlimab Monoclonal antibody 160 mg

Indications