Comparing two treatments for advanced melanoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3, randomized, controlled trial evaluates the effectiveness of brenetafusp (IMC-F106C) combined with nivolumab against standard nivolumab regimens in patients with previously untreated advanced melanoma who are HLA-A*02:01-positive. The study aims to determine if the combination therapy can provide better outcomes than the standard treatment. Participants must have measurable disease and meet specific eligibility criteria, including having a confirmed diagnosis of Stage IV or unresectable Stage III melanoma.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arizona
  Tucson, Arizona, United States Recruiting
• University of California - San Diego
  La Jolla, California, United States Recruiting
• The Angeles Clinic and Research Institute- West Los Angeles
  Los Angeles, California, United States Recruiting
• ESC Norris Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting
• UCLA Hematology/Oncology
  Los Angeles, California, United States Recruiting
• Saint John's Health Center - John Wayne Cancer Institute (JWCI)
  Santa Monica, California, United States Recruiting

+161 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Immunocore Medical Information
• Email: medical.information@immunocore.com
• Phone: 844-466-8661

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using ctDNA to decide whether to add ipilimumab for people on nivolumab and relatlimab

  This tests whether using a ctDNA blood test to guide adding ipilimumab for adults with advanced or metastatic melanoma on nivolumab and relatlimab leads to longer progression-free survival.

  Recruiting Phase 2 NYU Langone Health · New York, New York · NCT07504796

• Comparing VO and Nivolumab to Standard Treatment for Advanced Melanoma

  This study is testing if a new combination of treatments, Vusolimogene Oderparepvec and nivolumab, can help people with advanced melanoma who haven't responded to other therapies feel better compared to standard treatments.

  Recruiting at 75 sites Phase 3 Replimune, Inc. · Gilbert, Arizona and 80 other locations · NCT06264180

• Combining Naltrexone and Propranolol with Immunotherapy for Advanced Melanoma

  This study is testing if combining two medications, naltrexone and propranolol, with immune therapy can help people with advanced melanoma feel better and improve their treatment results.

  Recruiting Phase 1 Rutgers, The State University of New Jersey · New Brunswick, New Jersey · NCT05968690

• Using memory-like natural killer cells with nivolumab and relatlimab for advanced melanoma after previous treatments

  This study is testing if a new type of immune cell treatment combined with two existing drugs can help people with advanced melanoma who haven't improved with previous therapies.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT05629546

• Intratumoral fluorescent nivolumab before surgery in head and neck cancer

  This study tests injecting fluorescently labeled nivolumab directly into head and neck tumors to see if it is safe and whether it reaches nearby lymph nodes before surgical removal.

  Recruiting Early Phase 1 Vanderbilt-Ingram Cancer Center · Nashville, Tennessee · NCT07741565

• Bexmarilimab plus nivolumab in solid tumors, melanoma, and NSCLC

  This trial tests whether adding bexmarilimab to nivolumab can help people with melanoma, non-small cell lung cancer, or other advanced solid tumors whose cancer stopped responding to immune therapy.

  Recruiting at 2 sites Phase 1/2 Institute of Cancer Research, United Kingdom · Manchester and 1 other locations · NCT07718243

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.