NCT03696069

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
501

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 9, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2020

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

October 3, 2018

Last Update Submit

January 27, 2022

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • Treatment free interval (TFI)

    Approximately 6 months

Secondary Outcomes (1)

  • Overall survival rate

    Approximately 6 months

Study Arms (1)

Patients treated with immunotherapy and BRAF/MEK inhibitors

Other: Non-Interventional

Interventions

Non-InterventionalOTHER

Non-Interventional

Patients treated with immunotherapy and BRAF/MEK inhibitors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with advanced melanoma treated with immunotherapy and BRAF/MEK inhibitors

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Boston, Massachusetts, 02199, United States

Location

Related Links

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 4, 2018

Study Start

January 9, 2019

Primary Completion

December 27, 2019

Study Completion

February 14, 2020

Last Updated

February 10, 2022

Record last verified: 2022-01

Locations

US(1)