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The purpose of this study is to investigate the real-world clinical outcomes of individuals that have been diagnosed with advanced melanoma who were treated with Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1L Nivolumab + Relatlimab cohort |
| ||
| 1L Nivolumab + Ipilimumab cohort |
| ||
| 1L Immunotherapy monotherapy cohort |
| ||
| 1L BRAF/MEKs inhibitors cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab + Relatlimab | Biological | As per product label |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Baseline | |
| Clinical characteristics: Location of metastatic sites | Baseline | |
| Clinical characteristics: Lactate dehydrogenate (LDH) test results | Baseline | |
| Clinical characteristics: BRAF status | Baseline | |
| Clinical characteristics: Eastern Cooperative Oncology Group Performance Status (ECOG PS) | Baseline | |
| Overall survival (OS) | Up to 3-years | |
| Real-world progression-free survival (rwPFS) | Up to 3-years |
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Inclusion Criteria:
Participants in the advanced melanoma cohort
Participants receiving Nivolumab + Relatlimab between March 18, 2022 and September 30, 2024 or other therapies (Nivolumab + Ipilimumab, immunotherapy monotherapy, BRAF/MEK inhibitors) between March 18, 2022 and November 30, 2024 (or date of the most recent data cut off)
Participants ≥18 years old on index date
Participants with ≥1 month of medical data after the index date (inclusive), unless patient died within this period
Exclusion Criteria:
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The study population will include adults identified from the Flatiron database that have been diagnosed with advanced melanoma and who have initiated treatment with either Nivolumab in combination with Relatlimab, Nivolumab in combination with Ipilimumab, immuno-oncology monotherapy or BRAF/MEK inhibitors therapy in the real-world clinical settings
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bristol Myers Squibb | Princeton | New Jersey | 08540-4715 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Nivolumab + Ipilimumab |
| Biological |
As per product label |
|
| Immunotherapy monotherapy | Biological | As per product label |
|
| BRAF/MEK inhibitors | Drug | As per product label |
|
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000721227 | relatlimab |
| D000074324 | Ipilimumab |
| 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 |
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