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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)

This is a phase 3, randomized, controlled study of IMC-F106C plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.


Why this Research Matters

You are being asked to be in this research study because you are an adult with advanced melanoma (a kind of skin cancer) that has spread or cannot be surgically removed. This study includes participants with advanced melanoma from any part of the body except the eye. This study plans to learn more about if the study drug (IMC-F106C), in combination with a standard therapy (nivolumab), works better than the standard therapy (nivolumab alone or in combination with relatlimab) at making tumors stop growing (or shrink). A second purpose is to better understand the safety of IMC-F106C in combination with nivolumab and to learn whether a lower or higher dose of IMC-F106C in combination with this standard therapy works better and/or is safer. This study will also look at how well you feel after you receive the study drug or the standard therapy.


Who can Participate

Adult

Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov


Study ID

Protocol Number: 23-2225
More information available at ClinicalTrials.gov: NCT06112314

Meet the Team

Image of Principal Investigator

Luke Mantle, MD, BS, BM

Principal Investigator


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