A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Skin Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/10/2018 |
| Start Date: | July 31, 2018 |
| End Date: | October 29, 2019 |
A Retrospective Observational Study Comparing Nivolumab + Ipilimumab Combination vs. Nivolumab Monotherapy as First Line Treatment of Metastatic PD-L1 Positive Melanoma in the US
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
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
Inclusion Criteria:
- Adults 18 years or older
- First advanced of diagnosis of metastatic/Stage IV) melanoma
- Tested for PD-L1 expression with a tumor proportion score (TPS) greater than or equal
to 1% (Phase 1 data collection)
- Initiating a first line of therapy during the index period between October 1, 2015
through July 1, 2017
- Medical history available for medical chart abstraction from date of diagnosis through
most recent or current therapy (defined as end of data collection period)
Exclusion Criteria:
- Patients enrolled in a cancer treatment-related clinical trial prior to first line
therapy initiation for metastatic/Stage IV) melanoma
Other protocol defined inclusion/exclusion criteria could apply
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