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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Melanoma

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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form