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The purpose of this study is to examine real-world data among participants with stage IIIa melanoma initiating nivolumab as adjuvant treatment in the community practice setting by utilizing patient data from the United States Oncology Network (USON) iKnowMed (iKM) electronic health records (EHR) database.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nivolumab Monotherapy | Participants who started adjuvant nivolumab | ||
| Pembrolizumab Monotherapy | Participants who started adjuvant pembrolizumab | ||
| Dabrafenib + Trametinib Combination Therapy | Participants who started adjuvant dabrafenib + trametinib combination therapy | ||
| No Treatment of a Systemic Therapy | Participants with no systemic treatment during the study observation period until record of recurrence |
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| Measure | Description | Time Frame |
|---|---|---|
| Time to Treatment Discontinuation (TTD) | Up to 39 Months | |
| Recurrence-free Survival (RFS) | Up to 39 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-related Adverse Events (AEs) | Up to 39 Months | |
| Time to Next Treatment (TTNT) | Up to 39 Months | |
| Number of Participants with Treatment-Related Hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants diagnosed with stage IIIA melanoma receiving an adjuvant systemic treatment regimen in the USON iKM EHR database were identified.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | The Woodlands | Texas | 77380 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
| Investigator Inquiry Form |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| Up to 39 Months |
| Number of Participants with Emergency Department Visits | Up to 39 Months |
| Overall Survival (OS) | Up to 39 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 |