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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

September 11, 2018

Estimated Primary Completion Date

February 22, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment free interval (TFI)[ Time Frame: Approximately 6 months ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Overall survival rate[ Time Frame: Approximately 6 months ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Other: Non-Interventional
Non-Interventional

Study Arms

: Patients treated with immunotherapy and BRAF/MEK inhibitors

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

400

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 15, 2019

Estimated Primary Completion Date

February 22, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名