Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma
NCT07223411 · Phase II · Pittsburgh, Pennsylvania, United States
- Condition
- Melanoma
- Disease stage
- Stage I-IV
- Phase
- Phase II
- Study type
- DRUG
- Intervention
- Fianlimab + Cemiplimab, Relatlimab + Nivolumab
- Age
- 18 Years to
- Gender
- All
- Sponsor
- John Kirkwood
- Research institution
- John Kirkwood
- Facility
- UPMC Hillman Cancer Center
- Research center
- UPMC Hillman Cancer Center
Summary
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.
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. \-
Primary outcomes
Single-cell analysis of CD4+ T cells
Secondary outcomes
Immunological response of CD4+ T cells; Multiplexed immunofluorescence; Multiplexed immunofluorescence