PRISM: This study will assess the safety and efficacy of combining immunotherapy treatments, compared with the standard the immunotherapy regimen in its own, in participants with untreated advanced melanoma.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)

Trial purpose

Cancer treatment

Tumor type

Skin

Age

18+

Trial acronym

PRISM

Summary

This Phase 3 study will assess the the safety and efficacy of a new treatment (IMC-F106C) combined with Nivolumab, compared with standard treatment of Nivolumab on its own, in participants with HLA-A*02:01-positive untreated advanced melanoma.

Participants will be randomally allocated into one of three groups:

Experimental Arm A: Participants will receive a low dose of IMC-F106C via IV infusion once a week for the first 12 weeks, then every 2 weeks until Week 51, and then every 4 weeks until Week 101. Participants in this arm will also recieve Nivolumab via IV fusion every four weeks until Week 101.

Experimental Arm B: Participants will receive a high dose of IMC-F106C via IV fusion once a week for the first 12 weeks, then every 2 weeks until Week 51, and then every 4 weeks until Week 101. Participants will also recieve Nivolumab via IV infusion every four weeks is until Week 101.

Active Comparator Arm C: Participants receive Nivolumab on its own, or Nivolumab + Relatlimab, every four weeks via IV infusion until Week 101.

Conditions

This trial is treating people with advanced melanoma