Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regeneron Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fianlimab + cemiplimab | Patients who received fianlimab + cemiplimab treatment under protocol NCT06246916. |
| |
| Opdualag (relatlimab + nivolumab) | Patients who received Opdualag (relatlimab + nivolumab) under protocol NCT06246916. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fianlimab + Cemiplimab | Drug | Patients treated with Fianlimab 1600 mg + Cemiplimab 350 mg under protocol NCT06246916 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Single-cell analysis of CD4+ T cells | Single-cell RNAseq analysis of CD8+ T cells and other immune cells in blood and tumor biopsies. | Up to 39 months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunological response of CD4+ T cells | Single-cell analysis of CD4+ T cell (frequency) and other immune cells in blood and tumor biopsies. Analysis of single-cell RNA-seq data to obtain gene module scores for each CD4+ T cell or myeloid cell in whole blood and tumor biopsies will be classified as binary: 1 (co-expressing cytotoxic and exhaustion gene modules) or 0 (no co-expression). | Up to 39 months |
Not provided
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:
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.
-
Not provided
Not provided
Not provided
Not provided
Study participants who met inclusion criteria for clinical trial NCT06246916
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Danielle L Bednarz, RN | Contact | 4126231191 | bednarzdl@upmc.edu | |
| Amy Rose, RN | Contact | 4126478587 | kennaj@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| John M Kirkwood, MD | UPMC Hillman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15232 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Relatlimab + Nivolumab | Drug | Patients treated with Relatlimab 160 mg + Nivolumab 480 mg under protocol NCT06246916 |
|
|
| Multiplexed immunofluorescence | Degree of immune infiltration major immune subsets in the tumor microenvironment. The density of immune cells relative to the total number of cells in the tumor tissue will be calculated for each patient. | Up to 39 months |
| Multiplexed immunofluorescence | Frequencies of major immune subsets in the tumor microenvironment. The density of immune cells relative to the total number of cells in the tumor tissue will be calculated for each patient. | Up to 39 months |
| ID | Term |
|---|---|
| C000627974 | cemiplimab |
| C000721227 | relatlimab |
| D000077594 | Nivolumab |
| C000729737 | Opdualag |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided