A Comparison of Nivolumab-based Treatments in a Real-world PD-L1 Positive Metastatic Melanoma Population in the US

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Melanoma

Treatments: Other: Non-Interventional

Study type: Observational

Funder types: Industry

Identifiers

NCT03732560

CA209-8RW

Details and patient eligibility

About

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

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 2 patient groups

Patients undergoing treatment with nivolumab and ipilimumab

Treatment:

Other: Non-Interventional

Patients undergoing treatment with nivolumab

Treatment:

Other: Non-Interventional