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Clinical Trials in the UK / NCT06112314
Recruiting Phase 3

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

NCT06112314 · tracked via the Priya Life Science UK tracker
Sponsor
Immunocore Ltd
Phase
Phase 3
Started
2024-06-05
Last updated
2026-02-25

Condition(s) studied

Advanced Melanoma

Investigational drug(s) / intervention(s)

BrenetafuspNivolumabNivolumab + Relatlimab

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (211)

FacilityCityRegionStatus
University of Arizona Tucson Arizona Recruiting
University of California - San Diego La Jolla California Recruiting
The Angeles Clinic and Research Institute- West Los Angeles Los Angeles California Recruiting
ESC Norris Comprehensive Cancer Center Los Angeles California Recruiting
UCLA Hematology/Oncology Los Angeles California Recruiting
Stanford Cancer Institute - Stanford Cancer Center Palo Alto Palo Alto California Completed
Saint John's Health Center - John Wayne Cancer Institute (JWCI) Santa Monica California Recruiting
University of Colorado, Anschutz Medical Campus Aurora Colorado Recruiting
The Melanoma & Skin Cancer Institute Denver Colorado Recruiting
UConn Health-Farmington (University of Connecticut Health Center (UCHC)) Farmington Connecticut Completed
Georgetown University Washington D.C. District of Columbia Recruiting
Mayo Clinic Florida Jacksonville Florida Recruiting
University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami Miami Florida Recruiting
Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI Chicago Illinois Recruiting
The University of Kansas Cancer Center (KUCC) - Westwood Westwood Kansas Recruiting
St. Elizabeth Healthcare - Edgewood Edgewood Kentucky Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Henry Ford Cancer Center - Michigan Detroit Michigan Recruiting
Allina Health Cancer Institute - Minneapolis Minneapolis Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Completed
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey Recruiting
Northwell Health Cancer Institute Lake Success New York Recruiting
Columbia University Medical Center New York New York Completed
The Ohio State University Columbus Ohio Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Prisma Health Cancer Institute Greenville South Carolina Recruiting
Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC) Spartanburg South Carolina Recruiting
The University of Tennessee - Knoxville (UTK) Knoxville Tennessee Recruiting
Sarah Cannon Research Institute: USA/TN Nashville Tennessee Recruiting
Tennessee Oncology, PLLC Nashville Tennessee Recruiting
University of Texas Southwestern Dallas Texas Recruiting
University of Utah Huntsman Cancer Institute Salt Lake City Utah Recruiting
UVA Health-UVA Emily Couric Clinical Cancer Center Charlottesville Virginia Recruiting
Virginia Commonwealth University (VCU) - Massey Cancer Center Richmond Virginia Recruiting
Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus Seattle Washington Recruiting
Sanatorio Finochietto Caba Buenos Aires Recruiting
Clínica Adventista Belgrano - Sector Investigación Caba Buenos Aires Recruiting
Hospital Italiano de Buenos Aires (HIBA) Buenos Aires Argentina Recruiting

+ 171 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06112314 on ClinicalTrials.gov ↗ ← All trials in the UK