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

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: Immunocore Ltd · Participants: 680 · Started: Jun 5, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06112314

Locations in the U.S.

ArizonaUniversity of Arizona, Tucson
CaliforniaUniversity of California - San Diego, La Jolla
ESC Norris Comprehensive Cancer Center, Los Angeles
The Angeles Clinic and Research Institute- West Los Angeles, Los Angeles
UCLA Hematology/Oncology, Los Angeles
Saint John's Health Center - John Wayne Cancer Institute (JWCI), Santa Monica
ColoradoUniversity of Colorado, Anschutz Medical Campus, Aurora
The Melanoma & Skin Cancer Institute, Denver
District of ColumbiaGeorgetown University, Washington D.C.
FloridaMayo Clinic Florida, Jacksonville
University of Miami Health System-Sylvester Comprehensive Cancer Center-Miami, Miami
IllinoisNorthwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI, Chicago
KansasThe University of Kansas Cancer Center (KUCC) - Westwood, Westwood
KentuckySt. Elizabeth Healthcare - Edgewood, Edgewood
MassachusettsDana Farber Cancer Institute, Boston
Massachusetts General Hospital, Boston
MichiganHenry Ford Cancer Center - Michigan, Detroit
MinnesotaAllina Health Cancer Institute - Minneapolis, Minneapolis
New JerseyJohn Theurer Cancer Center at Hackensack University Medical Center, Hackensack
New YorkNorthwell Health Cancer Institute, Lake Success
OhioThe Ohio State University, Columbus
PennsylvaniaThomas Jefferson University, Philadelphia
UPMC Hillman Cancer Center, Pittsburgh
South CarolinaPrisma Health Cancer Institute, Greenville
Spartanburg Regional Healthcare System - Spartanburg Medical Center (SMC), Spartanburg
TennesseeThe University of Tennessee - Knoxville (UTK), Knoxville
Sarah Cannon Research Institute: USA/TN, Nashville
Tennessee Oncology, PLLC, Nashville
TexasUniversity of Texas Southwestern, Dallas
UtahUniversity of Utah Huntsman Cancer Institute, Salt Lake City
VirginiaUVA Health-UVA Emily Couric Clinical Cancer Center, Charlottesville
Virginia Commonwealth University (VCU) - Massey Cancer Center, Richmond
WashingtonSwedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus, Seattle

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.