A Study is to Understand the Treatment Patterns for Immunotherapy Agents and BRAF/MEK Inhibitors Used in the Treatment of Advanced Melanoma

Completed

• Conditions: Melanoma
• Interventions: Other: Non-Interventional

• Registration Number: NCT03696069
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The goal of the study is to understand the treatment patterns for immunotherapy agents and BRAF/MEK inhibitors used in the treatment of advanced melanoma

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Study Start: 2019-01-09
• Primary Completion: 2019-12-27
• Study Completion: 2020-02-14
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

Inclusion Criteria

• Patients must have ≥1 medical or pharmacy claim for nivolumab, ipilimumab, pembrolizumab, nivolumab+ipilimumab (on the same day), dabrafenib, vemurafenib, cobimetinib, trametinib, dabrafenib+trametinib (on the same day) and vemurafenib+cobimetinib (on the same day)
• Patients must have ≥6 months of continuous health plan enrollment prior to index date
• Patients must have ≥2 medical claims at least 30 days apart with a diagnosis for melanoma during the study period AND ≥1 diagnosis for melanoma during the baseline period prior to or on the index date

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Exclusion Criteria

• Patients with ≥1 claim for the agents of interest including immunotherapy agents and BRAF/MEK inhibitors between the first diagnosis of metastatic disease and the day prior to the index date will be excluded
• Patients with a claim for acquired immunodeficiency virus (AIDS) anytime during the study period
• Patients under the age of 18 as of index date

Other protocol defined inclusion/exclusion criteria could apply

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients treated with immunotherapy and BRAF/MEK inhibitors	Non-Interventional	-

Primary Outcome Measures

Name	Time	Method
Treatment free interval (TFI)	Approximately 6 months

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	Approximately 6 months

Trial Locations

Locations (1)

Local Institution; 🇺🇸 Boston, Massachusetts, United States