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The goal of this study is to describe patient characteristics, treatment outcomes and adverse events for patients with metastatic melanoma testing positive for PD-L1 expression treated first line (1L) with either nivolumab and ipilimumab in combination (NIVO + IPI) or nivolumab (NIVO) monotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing treatment with nivolumab and ipilimumab |
| ||
| Patients undergoing treatment with nivolumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional | Other | Non-Interventional |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) from Advanced Diagnosis | Minimum follow up 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) from Advanced Diagnosis | Minimum follow up 1 year | |
| Overall Survival (OS) from 1L Therapy Initiation | Minimum follow up 1 year | |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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Adult metastatic melanoma patients with a positive PD-L1 expression level (above 1%) treated with nivolumab or nivolumab+ipilimumab in the first line setting in the US between Oct 1, 2015 and July 1, 2017
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Parsippany | New Jersey | 07054 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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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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| Progression Free Survival (PFS) from Index Date |
| Minimum follow up 1 year |
| Objective Response Rate (ORR) | Minimum follow up 1 year |
| Best Therapy Response | Best response (complete response, CR or partial response, PR) will be measured from the start of index treatment to progression or recurrence. Outcome will be reported as the percent of patients achieving best response from the total population of patients in a study arm. | Minimum follow up 1 year |
| Time to Best Therapy Response | Minimum follow up 1 year |
| Time to Loss of Peak Response | Minimum follow up 1 year |
| Response Evaluation Criteria in Solid Tumors (RECIST) | Minimum follow up 1 year |
| Immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) criteria | Minimum follow up 1 year |
| Incidence of AE's | Minimum follow up 1 year |
| Incidence of SAE's | Minimum follow up 1 year |
| 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 |