Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fianlimab + Cemiplimab, Relatlimab + Nivolumab.
- Who it may be relevant to
- Registry conditions: Locally Advanced Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Detailed description
Cutaneous melanoma is an aggressive skin cancer which, in the metastatic setting, has a historic 5-year survival rate of \<30%. In 2023, about 97,610 new cases of melanoma were estimated to occur in the US, with about 7,990 deaths. GLOBACON reported 324,635 cases of melanoma globally in 2020, which constituted about 1.7% of all cancers and 57,043 melanoma-associated deaths.
The parent trial of this corollary study is a randomized, open-label, multicenter phase 3 study comparing the anti-tumor activity of fixed-dose combination (FDC) of fianlimab + cemiplimab versus the FDC of relatlimab + nivolumab (referred to as Opdualag™) in participants with unresectable or metastatic melanoma (stage III-IV). This corollary study will explore the immunological response of CD8, CD4, and other immune cells in the blood and tumor microenvironment of patients in response to the provided treatments.
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]
Secondary outcome measures (3)
- Immunological response of CD4+ T cells [Time frame: Up to 39 months]
- Multiplexed immunofluorescence [Time frame: Up to 39 months]
- Multiplexed immunofluorescence [Time frame: Up to 39 months]
Eligibility criteria
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.
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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UPMC Hillman Cancer Center — Pittsburgh
Identifiers
NCT: NCT07223411 · HCC 25-009