Tests brenetafusp with nivolumab against standard nivolumab treatments in advanced melanoma
Tests brenetafusp plus nivolumab in adults with untreated advanced melanoma.
Plain-language title generated from the registry record
Registry title: IMC-F106C Regimen Versus Nivolumab Regimens in Previously Untreated Advanced Melanoma (PRISM-MEL-301)
Key facts
- Where
- Aurora, Boston, Charlottesville, Chicago, Columbus, Dallas, Denver, Detroit, Edgewood, Farmington, Greenville, Hackensack, Jacksonville, Knoxville, La Jolla, Lake Success, Los Angeles, Miami, Minneapolis, Nashville, New York, Palo Alto, Philadelphia, Pittsburgh, Richmond, Salt Lake City, Santa Monica, Seattle, Spartanburg, St Louis, Tucson, Washington D.C., and Westwood, United StatesSee the 37 sites
- Phase
- Phase 3
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United StatesTaking people
- Dana-Farber Cancer InstituteBoston, United StatesTaking people
- Massachusetts General HospitalBoston, United StatesTaking people
- UVA Health-UVA Emily Couric Clinical Cancer CenterCharlottesville, United StatesTaking people
- Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTIChicago, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- University of Texas, SouthwesternDallas, United StatesTaking people
- The Melanoma & Skin Cancer InstituteDenver, United StatesTaking people
- Henry Ford Cancer Center - MichiganDetroit, United StatesTaking people
- St. Elizabeth Healthcare - EdgewoodEdgewood, United StatesTaking people
- UConn Health-Farmington (University of Connecticut Health Center (UCHC))Farmington, United StatesNo longer taking part
- Prisma Health Cancer InstituteGreenville, United StatesTaking people
- John Theurer Cancer Center at Hackensack University Medical CenterHackensack, United StatesTaking people
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- The University of Tennessee - Knoxville (UTK)Knoxville, United StatesTaking people
- University of California San DiegoLa Jolla, United StatesTaking people
- Northwell Health Cancer InstituteLake Success, United StatesTaking people
- ESC Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- The Angeles Clinic and Research Institute- West Los AngelesLos Angeles, United StatesTaking people
- UCLA Hematology-OncologyLos Angeles, United StatesTaking people
- University of Miami Health System-Sylvester Comprehensive Cancer Center-MiamiMiami, United StatesTaking people
- Allina Health Cancer Institute - MinneapolisMinneapolis, United StatesTaking people
- Sarah Cannon Research Institute: USA/TNNashville, United StatesTaking people
- Tennessee Oncology, PLLCNashville, United StatesTaking people
- Columbia University Medical CenterNew York, United StatesNo longer taking part
- Stanford Cancer Institute - Stanford Cancer Center Palo AltoPalo Alto, United StatesNo longer taking part
- Thomas Jefferson UniversityPhiladelphia, United StatesTaking people
- UPMC Hillman Cancer CenterPittsburgh, United StatesTaking people
- Virginia Commonwealth University (Vcu) Massey Cancer CenterRichmond, United StatesTaking people
- University of Utah - Huntsman Cancer InstituteSalt Lake City, United StatesTaking people
- Saint John's Health Center - John Wayne Cancer Institute (JWCI)Santa Monica, United StatesTaking people
- Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill CampusSeattle, United StatesTaking people
- Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC)Spartanburg, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- University of ArizonaTucson, United StatesTaking people
- Georgetown UniversityWashington D.C., United StatesTaking people
- The University of Kansas Cancer Center (KUCC) - WestwoodWestwood, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Immunocore Ltd
- Trial code
- NCT06112314
- Record updated
- 25 February 2026
- Original description
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.Read full original descriptionShow less
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 brenetafusp (IMC-F106C) plus nivolumab compared to standard nivolumab regimens in HLA-A*02:01-positive participants with previously untreated advanced melanoma.
Inclusion: 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.
Exclusion: 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; Participants with a history of a malignant disease other than those being treated in this study; 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 with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis.