NCT07223411 · John Kirkwood
Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma
What this study is about
This translational study will examine the immune effector responses of patients who received a two-drug combination for first line therapy by examining tumor and peripheral blood of participants with unresectable locally advanced or metastatic melanoma.
View original scientific description
This translational study will examine the immune effector responses of patients who received a two-drug combination for first line therapy by examining tumor and peripheral blood of participants with unresectable locally advanced or metastatic melanoma.
Interventions
DRUG
Fianlimab + Cemiplimab
Patients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916
DRUG
Relatlimab + Nivolumab
Patients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916
Primary outcome measures
Single-cell analysis of CD4+ T cells
Time frame: Up to 39 months
Single-cell RNAseq analysis of CD8+ T cells and other immune cells in blood and tumor biopsies.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Study participants who meet inclusion criteria for the HCC 24-056 study will be eligible for this study.
- Participants must be willing to provide additional samples beyond what is required of them in HCC 24-056. These include:
- 3 additional tumor biopsies
- 3 additional blood draws
- Participants must have biopsiable non-target disease amenable to at least 3 biopsies.
- 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
- Pittsburgh, Pennsylvania
Collaborators
Regeneron Pharmaceuticals
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 26, 2025 · Source of record for eligibility and locations