Clinical trial · Observational
Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Melanoma | Melanoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fianlimab + Cemiplimab | Drug | — | UNRESOLVED |
| Relatlimab + Nivolumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- fianlimab + cemiplimab
- description
- Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916.
- interventionNames
- Drug: Fianlimab + Cemiplimab
- label
- Opdualag (relatlimab + nivolumab)
- description
- Patients who received Opdualag (relatlimab + nivolumab) under protocol NCT06246916.
- interventionNames
- Drug: Relatlimab + Nivolumab
Primary outcomes (1)
- measure
- Single-cell analysis of CD4+ T cells
- timeFrame
- Up to 39 months
- description
- Single-cell RNAseq analysis of CD8+ T cells and other immune cells in blood and tumor biopsies.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. \-
References
Publications (0)
Data not yet available