RECRUITING

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

Talk to us

Conditions

Advanced Melanoma

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-06-05
Study Completion:2027-10-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06112314

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants must be HLA-A\*02:01-positive
  2. * Participants must have histologically confirmed Stage IV or unresectable Stage III melanoma
  3. * Archived or fresh tumor tissue sample that must be confirmed as adequate
  4. * Participants must have measurable disease per RECIST 1.1
  5. * Participant must have BRAF V600 mutation status determined
  6. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  7. * 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
  1. * Participants with a history of a malignant disease other than those being treated in this study
  2. * Participants with untreated, active, or symptomatic central nervous system (CNS) metastases or carcinomatous meningitis
  3. * Hypersensitivity to IMC-F106C, nivolumab, relatlimab, or any associated excipients
  4. * Participants with clinically significant pulmonary disease or impaired lung function
  5. * Participants with clinically significant cardiac disease or impaired cardiac function
  6. * Participants with active autoimmune disease requiring immunosuppressive treatment
  7. * 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
  8. * Participants who received prior systemic anticancer therapy for unresectable or metastatic melanoma
  9. * Participants with a history of a life-threatening AE related to prior anti-PD-(L)1 or anti-LAG-3

Contacts and Locations

Study Contact

Immunocore Medical Information
CONTACT
844-466-8661
medical.information@immunocore.com
Immunocore Medical Information EU
CONTACT
+00 800-744-51111
medinfo.eu@immunocore.com

Study Locations (Sites)

The Angeles Clinic and Research Institute- West Los Angeles
Los Angeles, California, 90025
United States
ESC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
UCLA Hematology/Oncology
Los Angeles, California, 90095
United States
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Mayo Clinic Florida
Jacksonville, Florida, 32224
United States
Northwestern University - Robert H. Lurie Comprehensive Cancer Center - NMDTI
Chicago, Illinois, 60611
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Northwell Health Cancer Institute
Lake Success, New York, 11042
United States
Columbia University Medical Center
New York, New York, 10032
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Prisma Health Cancer Institute
Greenville, South Carolina, 29605
United States
Swedish Medical Center - Swedish Cancer Institute (SCI) - First Hill Campus
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Immunocore Ltd

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-05
Study Completion Date2027-10-16

Study Record Updates

Study Start Date2024-06-05
Study Completion Date2027-10-16

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Melanoma