Actively Recruiting
Dose-response Analysis of Nivolumab/Relatlimab (Opdualag) vs. Cemiplimab/Fianlimab in Relation to the Immune Response in Tumor and Blood for Unresectable or Metastatic Melanoma
Led by John Kirkwood · Updated on 2025-11-26
20
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
J
John Kirkwood
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research investigates immune responses in patients with unresectable locally advanced or metastatic melanoma who have received a two-drug combination as their first line of therapy. It focuses on comparing the immune activity in tumor and peripheral blood samples between two treatment combinations: fianlimab plus cemiplimab, and relatlimab plus nivolumab (Opdualag). The study builds on a parent phase 3 trial examining these treatments' anti-tumor effects in advanced melanoma. Participants in this corollary study are those who previously received either fianlimab plus cemiplimab or Opdualag under the parent trial protocol. The study involves collecting additional samples including three tumor biopsies and three blood draws to analyze immune cell responses, particularly CD4+ and CD8+ T cells, using methods like single-cell analysis and multiplexed immunofluorescence over a period of up to 39 months. During the study, participants will provide these extra samples beyond their parent trial requirements and sign informed consent. Researchers will monitor immune responses in tumors and blood, measuring changes in specific immune cells to understand treatment effects. The study's data collection and participant involvement may extend up to 39 months, focusing on detailed immune profiling to support understanding of the treatments' impact.
CONDITIONS
Brief Title
Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet the inclusion criteria of the parent HCC 24-056 study.
- Willingness to provide 3 additional tumor biopsies and 3 additional blood draws.
- Must have biopsiable non-target disease suitable for at least 3 biopsies.
- Ability to understand and willingness to sign informed consent.
You will not qualify if you...
- Participants who do not qualify for the parent HCC 24-056 study are not eligible for this study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Up to 39 months
Participants who received treatment in the parent study are observed to explore the immunological response in tumor and blood over time.
3 additional tumor biopsies and 3 additional blood draws over the study period
Trial Site Locations
Total: 1 location
1
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
Research Team
D
Danielle L Bednarz, RN
A
Amy Rose, RN
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here