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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2021-03-25

Brief Summary

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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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Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients undergoing treatment with nivolumab and ipilimumab

Non-Interventional

Intervention Type OTHER

Non-Interventional

Patients undergoing treatment with nivolumab

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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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)