Comparing two immunotherapy combinations and their immune effects in unresectable or metastatic 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 translational corollary follows participants enrolled in a randomized, open-label phase 3 comparison of fianlimab + cemiplimab versus relatlimab + nivolumab and focuses on immune changes rather than clinical outcomes. Participants who qualify for the parent protocol will provide additional samples, including three extra tumor biopsies and three extra blood draws over the course of treatment. Laboratory analyses will profile CD8, CD4, and other immune cell populations in the tumor microenvironment and peripheral blood to map treatment-associated immune effector responses. The goal is to link specific immune signatures to the two different drug combinations to inform biomarker development and mechanistic understanding.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
2. Participants must be willing to provide additional samples beyond what is required of them in HCC 24-056. These include:

   1. 3 additional tumor biopsies
   2. 3 additional blood draws
3. Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
4. Must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1\. Study participants who do not qualify to enroll in the HCC 24-056 study will not be eligible for this study.

\-

Where it's running

• UPMC Hillman Cancer Center
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: John M Kirkwood, MD — UPMC Hillman Cancer Center
• Study coordinator: Danielle L Bednarz, RN
• Email: bednarzdl@upmc.edu
• Phone: 4126231191

Similar studies

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

• Combining two experimental drugs for advanced melanoma treatment

  This study is testing if a new combination of two experimental drugs can help people with advanced melanoma more than the current approved treatments.

  Recruiting at 92 sites Phase 3 Regeneron Pharmaceuticals · Chandler, Arizona and 112 other locations · NCT06246916

• First-line immune-checkpoint antibody combinations for advanced clear cell kidney cancer

  This trial tests whether combining fianlimab and cemiplimab, with or without ipilimumab, works better than the standard ipilimumab plus nivolumab as first treatment for people with advanced clear cell kidney cancer.

  Recruiting at 5 sites Phase 2 Hoosier Cancer Research Network · Washington D.C., District of Columbia and 4 other locations · NCT07188896

• 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

• HEPZATO KIT with Opdualag for metastatic melanoma that has spread to the liver

  This will try adding HEPZATO KIT to Opdualag (nivolumab + relatlimab) to see if it's safe and helps people with metastatic melanoma that has spread to the liver.

  Recruiting Phase 1/2 University of Wisconsin, Madison · Madison, Wisconsin · NCT07281924

• Capecitabine/Oxaliplatin chemo with cemiplimab with or without fianlimab or REGN7075 for locally advanced rectal cancer

  This trial tests whether adding cemiplimab, cemiplimab with fianlimab, or cemiplimab with REGN7075 to CAPOX can help people with MSS locally advanced rectal cancer before surgery.

  Recruiting Phase 2 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Baltimore, Maryland · NCT07281768

• Cemiplimab alone or with fianlimab after stereotactic body radiation for oligometastatic clear cell kidney cancer

  This trial will test whether giving cemiplimab alone or with fianlimab after stereotactic body radiation helps people with oligometastatic clear cell kidney cancer stay free of recurrence longer.

  Recruiting Phase 2 University of Oklahoma · Oklahoma City, Oklahoma · NCT07223541

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.