Comparing two immunotherapy combinations and their immune effects in unresectable or metastatic melanoma
Dose-response Analysis of Nivolumab/Relatlimab in the Fixed-dosed Combination 'Opdualag' vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood for Participants With Unresectable or Metastatic Melanoma: A Corollary Study of HCC 24-056 (NCT06246916)
This will test whether two different first-line immunotherapy combinations produce different immune responses in tumors and blood of people with unresectable or metastatic melanoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Drugs / interventions | fianlimab, cemiplimab, relatlimab, nivolumab |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07223411 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with unresectable locally advanced or metastatic melanoma who are enrolled in the parent HCC 24-056 trial and are willing and able to undergo three extra tumor biopsies and three extra blood draws.
Not a fit: Patients who are not enrolled in the parent trial, who lack biopsiable non-target disease, or who cannot tolerate additional tumor biopsies are unlikely to benefit from participating in this corollary study.
Why it matters
Potential benefit: If successful, this work could identify immune signatures that help predict which immunotherapy combination is more likely to work for an individual patient.
How similar studies have performed: Previous clinical trials of immune checkpoint inhibitor combinations have demonstrated clinical benefit and correlative translational studies have identified useful immune biomarkers, but direct immune-profile comparisons between these specific combinations remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburgh, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.