Recruiting

Phase 3

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

Sponsor:

Immunocore Ltd

Code:

NCT06112314

Conditions

Advanced Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brenetafusp

Nivolumab

Nivolumab + Relatlimab

Study Details

Brief summary:

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.

Conditions

Advanced Melanoma

Study ID

NCT06112314

Start date

Jun 5, 2024

Status verified date

Feb, 2026

Completion date

Oct 16, 2027

Anticipated

Primary completion date

Oct 16, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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 Criteria:

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

Study Design

Enrollment

680 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Brenetafusp Low Dose + Nivolumab

Participants receive brenetafusp Low Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W.

Closed to randomization after dose recommendation by the IDMC in November 2025.

experimental: Arm B: Brenetafusp High Dose + Nivolumab

Participants receive brenetafusp High Dose once weekly (QW) for the first 13 weeks, then every 2 weeks (Q2W) through Week 51, and then every 4 weeks (Q4W). Nivolumab is given Q4W.

Selected as go-forward experimental arm after dose recommendation by the IDMC in November 2025

active comparator: Arm C: Nivolumab OR Nivolumab + Relatlimab

Participants receive nivolumab 480 mg monotherapy, or nivolumab 480 mg + relatlimab 160 mg, Q4W.

Interventions

Brenetafusp

Soluble PRAME-specific T cell receptor with anti-CD3 scFV concentrate for solution for intravenous (IV) infusion at a unit dose of 0.2 mg/mL.

Nivolumab

Concentrate for solution for infusion at a unit dose of 10 mg/mL.

Nivolumab + Relatlimab

Concentrate for solution for infusion at a unit dose of 16 mg/mL.

Primary outcome measure

Progression-Free Survival (PFS) [ Time Frame: Up to ~45 months ]

Central Contacts and Locations

Central contacts

Immunocore Medical Information

844-466-8661 medical.information@immunocore.com

Immunocore Medical Information EU

+00 800-744-51111 medinfo.eu@immunocore.com

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85720

Contacts

Terri Katz

520-621-2029 tkatz@arizona.edu

University of California - San Diego

Recruiting

La Jolla, California, United States, 92093-0698

Contacts

Katie O'Neil

858-822-6575 croneil@health.ucsd.edu

The Angeles Clinic and Research Institute- West Los Angeles

Recruiting

Los Angeles, California, United States, 90025

Contacts

Saba Mukarram

310-231-2181 SMukarram@theangelesclinic.org

ESC Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Sandy Tran

323-865-3935 Sandy.tran@med.usc.edu

UCLA Hematology/Oncology

Recruiting

Los Angeles, California, United States, 90095

Contacts

Jessica Crocker

310-794-3266 JCrocker@mednet.ucla.edu

Saint John's Health Center - John Wayne Cancer Institute (JWCI)

Recruiting

Santa Monica, California, United States, 90404

Contacts

Maribel Ramirez

310-582-7457 maribel.ramirez1@providence.org

University of Colorado, Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Kayla Vondran

720-848-9381 KAYLA.VONDRAN@CUANSCHUTZ.EDU

The Melanoma & Skin Cancer Institute

Recruiting

Denver, Colorado, United States, 80222

Contacts

Brandon Keith

303-777-2663 bkeith@westernstatesncorp.org

Georgetown University

Recruiting

Washington D.C., District of Columbia, United States, 20007

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Heidi Turner

904-953-5323 Turner.Heidi@mayo.edu

University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

CRSCutaneous@miami.edu

Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI

Recruiting

Chicago, Illinois, United States, 60611

The University of Kansas Cancer Center (KUCC) - Westwood

Recruiting

Westwood, Kansas, United States, 66205

Contacts

CT Nurse Navigator

913-945-7552 CTNurseNav@kumc.edu

St. Elizabeth Healthcare - Edgewood

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Elizabeth Beatty, CRC

859-301-4243 Elizabeth.Beatty@stelizabeth.com

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Kamaneh Montazeri, MD

617-724-4000 kmontazeri@mgh.harvard.edu

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Linnea Drew

617-632-6704 linneam_drew@dfci.harvard.edu

Henry Ford Cancer Center - Michigan

Recruiting

Detroit, Michigan, United States, 04820

Contacts

Bethany Adams

248-224-7345 badams19@hfhs.org

Allina Health Cancer Institute - Minneapolis

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Jonathan Alexander

612-863-8625 jonathan.alexander@allina.com

John Theurer Cancer Center at Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Oncology Clinical Research Referral Office

551-996-1777 OncologyResearchReferral@hmhn.org

Northwell Health Cancer Institute

Recruiting

Lake Success, New York, United States, 11042

Contacts

Sarilee Liz

sliz@northwell.edu

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Sierra Cimafranca

614-685-1911 Sierra.Cimafranca@osumc.edu

Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Madeleine Martinelli

267-414-8820 Madeleine.martinelli@jefferson.edu

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Kelly Schroder

412-623-3544 schroderka@upmc.edu

Prisma Health Cancer Institute

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Lisa Johnson

Lisa.johnson@prismahealth.org

Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC)

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Kristen Ford, RN MSN

864-530-6554 kford@gibbscc.org

The University of Tennessee - Knoxville (UTK)

Recruiting

Knoxville, Tennessee, United States, 37920

Contacts

Megan McKenzie, RN

865-305-6284

Sarah Cannon Research Institute: USA/TN

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology, PLLC

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Mindy Jordan

888-555-2835 mejordan@tnonc.com

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75235-9179

Contacts

Desiree Pierre

214-645-9830 desiree.pierre@utsouthwestern.edu

University of Utah Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Shantae George

801-213-8486 shantae.george@hci.utah.edu

UVA Health-UVA Emily Couric Clinical Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

uvacancertrials@hscmail.mcc.virginia.edu

Virginia Commonwealth University (VCU) - Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23298-0070

Contacts

Faith McFadden

804-628-0616 masseyskinca@vcu.edu

Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus

Recruiting

Seattle, Washington, United States, 98104

Contacts

CancerResearch

206-215-3125 cancerresearch@swedish.org

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2C1

Contacts

Marcus Butler, MD

416-946-4501 marcus.butler@uhn.ca

Cross Cancer Institute

Recruiting

Edmonton, Canada, T6G 1Z2

Contacts

Dr. John Walker, MD

780-577-8082

More Information

Sponsor

Immunocore Ltd

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Immunocore Ltd on 2026-02-25.