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

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

• 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 effective methods of birth control from the study screening date until 5 months after the final dose of study intervention

🚫 You may not be able to join if…

• Participants with a history of a malignant disease other than those being treated in this study
• Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
• Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
• Participants with clinically significant pulmonary disease or impaired lung function
• Participants with clinically significant cardiac disease or impaired cardiac function
• Participants with active autoimmune disease requiring immunosuppressive treatment
• Participants with any medical condition that is poorly controlled or that would, in the Investigator's or Sponsor's judgment, adversely impact the participant's participation in the clinical study due to safety concerns, compliance with clinical study procedures, or interpretation of study results
• Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
• Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Where this trial is running

• University of Arizona, Tucson, Arizona, United States
• University of California - San Diego, La Jolla, California, United States
• The Angeles Clinic and Research Institute- West Los Angeles, Los Angeles, California, United States
• ESC Norris Comprehensive Cancer Center, Los Angeles, California, United States
• UCLA Hematology/Oncology, Los Angeles, California, United States
• Stanford Cancer Institute - Stanford Cancer Center Palo Alto, Palo Alto, California, United States
• Saint John's Health Center - John Wayne Cancer Institute (JWCI), Santa Monica, California, United States
• University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States
• The Melanoma & Skin Cancer Institute, Denver, Colorado, United States
• UConn Health-Farmington (University of Connecticut Health Center (UCHC)), Farmington, Connecticut, United States
• Georgetown University, Washington D.C., District of Columbia, United States
• Mayo Clinic Florida, Jacksonville, Florida, United States

+ 199 more sites.

Who to contact

Immunocore Medical Information · 844-466-8661 · medical.information@immunocore.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06112314.