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

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.

Conditions

Advanced Melanoma

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Advanced Melanoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

The Angeles Clinic and Research Institute- West Los Angeles, Los Angeles, California, United States, 90025

Los Angeles

ESC Norris Comprehensive Cancer Center, Los Angeles, California, United States, 90033

Los Angeles

UCLA Hematology/Oncology, Los Angeles, California, United States, 90095

Aurora

University of Colorado, Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Jacksonville

Mayo Clinic Florida, Jacksonville, Florida, United States, 32224

Chicago

Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI, Chicago, Illinois, United States, 60611

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Hackensack

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Lake Success

Northwell Health Cancer Institute, Lake Success, New York, United States, 11042

New York

Columbia University Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Immunocore Ltd,

Study Record Dates

2027-10-16