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

Recruiting now · Phase 3

Conditions studied: Advanced Melanoma

In brief

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.

Key facts

Study ID

NCT06112314

Run by

Immunocore Ltd

People needed

680

Starts

2024-06-05

Expected to finish

2027-10-16

Last updated by the study team

2026-02-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Prisma Health Cancer Institute — Greenville, South Carolina, United States (enrolling)
• ESC Norris Comprehensive Cancer Center — Los Angeles, California, United States (enrolling)
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
• University of Arizona — Tucson, Arizona, United States (enrolling)
• Saint John's Health Center - John Wayne Cancer Institute (JWCI) — Santa Monica, California, United States (enrolling)
• University of Colorado, Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• The Melanoma & Skin Cancer Institute — Denver, Colorado, United States (enrolling)
• University of California - San Diego — La Jolla, California, United States (enrolling)
• Georgetown University — Washington D.C., District of Columbia, United States (enrolling)
• The Angeles Clinic and Research Institute- West Los Angeles — Los Angeles, California, United States (enrolling)
• University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami — Miami, Florida, United States (enrolling)
• Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI — Chicago, Illinois, United States (enrolling)
• The University of Kansas Cancer Center (KUCC) - Westwood — Westwood, Kansas, United States (enrolling)
• St. Elizabeth Healthcare - Edgewood — Edgewood, Kentucky, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Henry Ford Cancer Center - Michigan — Detroit, Michigan, United States (enrolling)
• Allina Health Cancer Institute - Minneapolis — Minneapolis, Minnesota, United States (enrolling)
• UCLA Hematology/Oncology — Los Angeles, California, United States (enrolling)
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Northwell Health Cancer Institute — Lake Success, New York, United States (enrolling)
• Mayo Clinic Florida — Jacksonville, Florida, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC) — Spartanburg, South Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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