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)

Primary Objective

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.

Is This Study For You?

Let's Get Started!

Description

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.

Details
Age
Adult
Eligibility
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
Locations

CTRC Inpatient
University of Colorado Hospital

Principal Investigator
Photograph of Luke Mantle

Luke Mantle

Study ID

Protocol Number: 23-2225

More information available at ClinicalTrials.gov: NCT06112314

Categories

Is this Study for You?

Let's Get Started!

Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers