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

NCT ID: NCT03696069

Last Updated: 2022-02-10

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

501 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-09

Study Completion Date

2020-02-14

Brief Summary

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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

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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 treated with immunotherapy and BRAF/MEK inhibitors

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Boston, Massachusetts, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CA209-8HC

Identifier Type: -

Identifier Source: org_study_id

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