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NCT03696069 Clinical Trial

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

Melanoma Clinical Trial

Official title:
Understanding the Treatment Patterns, Healthcare Resource Utilization, Costs of Care, and Clinical Outcomes Among Patients Treated for Advanced Melanoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03696069
Other study ID # CA209-8HC
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 9, 2019
Est. completion date February 14, 2020

Study information
Verified date January 2022
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 501
Est. completion date February 14, 2020
Est. primary completion date December 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Other protocol defined inclusion/exclusion criteria could apply

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations
Country Name City State
United States Local Institution Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment free interval (TFI) Approximately 6 months
Secondary Overall survival rate Approximately 6 months
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