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The purpose of this study is to understand the characteristics of adults diagnosed with with clinically palpable stage III resectable melanoma, the associated treatment patterns for their disease, and outcomes associated with the real-world use of neoadjuvant nivolumab+relatlimab or nivolumab+ipilimumab
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving nivolumab + relatlimab treatment |
| ||
| Participants receiving nivolumab + ipilimumab treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nivolumab + relatlimab | Biological | As prescribed by the treating clinician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant baseline demographics | Baseline | |
| Participant baseline clinical characteristics | Baseline | |
| Participant treatment history | Baseline | |
| Number of doses of index therapies received (neoadjuvant therapies) | Day 1 | |
| Types of surgeries received for melanoma after the index date | Up to 42-months | |
| Date of last radiation received for melanoma after the index date | Up to 42-months | |
| Types of regimens received for melanoma post-surgery in the adjuvant setting | Up to 42-months | |
| Number of doses of adjuvant therapies received (post-surgery) | Up to 42-months | |
| Dose modifications received by participants | Up to 42-months | |
| Rationale for dose modifications | Up to 42-months | |
| Rationale for treatment discontinuation | Up to 42-months |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will comprise of adult diagnosed with clinically palpable stage III resectable melanoma in the U.S. managed by physicians in Cardinal Health's OPEN treated with neoadjuvant nivolumab+relatimab or nivolumab+ipilimumab from 18 March 2022.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Health | Dublin | Ohio | 43017 | 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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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| C000721227 | relatlimab |
| D000074324 | Ipilimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Nivolumab + ipilimumab | Biological | As prescribed by the treating clinician |
|
| Overall survival (OS) | Up to 42-months |
| Time to treatment discontinuation (TTD) | Up to 42-months |
| Duration of treatment (DOT) | Up to 42-months |
| Time from neoadjuvant index treatment to adjuvant therapy | Up to 42-months |
| Time from neoadjuvant index treatment to surgery | Up to 42-months |
| Time from surgery to adjuvant therapy | Up to 42-months |
| Pathologic complete response (PCR) | Up to 42-months |
| Event-free survival (EFS) | Up to 42-months |
| Distant metastasis-free survival (DMFS) | Up to 42-months |
| Participant adverse events (AEs) | Up to 42-months |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |