Skip to main content
OpenTrials
Completed

NCT Number: NCT05260684

Comparative Effectiveness of Targeted Therapies in BRAF Positive Metastatic Melanoma in the US

This study aims to compare real-world effectiveness of BRAF/MEK inhibitors in BRAF-mutant metastatic melanoma patients in the United States by line of therapy.

The Flatiron Health electronic health record (EHR) data from US cancer clinics will be used for this retrospective database analysis.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed with melanoma based on International Classification of Disease 9th and 10th Revisions (ICD-9: 172.x; ICD-10: C43x, D03x) and ≥2 visits on different days in the Flatiron database on or after January 1, 2011.
  • Clinically confirmed diagnosis of melanoma with pathologic stages III or IV at initial diagnosis or earlier stage disease with a first locoregional or distant recurrence on or after January 1, 2011.
  • Age ≥18 years at the time of advanced melanoma diagnosis.
  • Evidence of ≥1 BRAF positive test result at any time based on laboratory or genetic analysis results.

Exclusion criteria

-• Patients with prior BRAF- or MEK-inhibitor therapy

  • Patients with ECOG performance status ≥ 2 (at the time of randomization for patients from COLUMBUS, during the baseline period for patients in Flatiron EHR)

Treatment and study plan

Encorafenib

Drug

450 mg QD

Other names: Administration route: Oral

Binimetinib

Drug

45 mg BID

Other names: Administration route: Oral

Vemurafenib

Drug

960 mg BID for 28 days/cycle

Other names: Administration route: Oral

Cobimetinib

Drug

60 mg QD for 21 days/cycle

Other names: Administration route: Oral

Dabrafenib

Drug

150 mg BID

Other names: Administration route: Oral

Trametinib

Drug

2 mg QD

Other names: Administration route: Oral

Primary outcomes

  1. Overall Survival (OS)

    Time frame: COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (92.7 months)

    As per COLUMBUS trial, OS was defined as the time from the date of randomization to the date of death due to any cause; if death was not observed, participants were censored at the date of last contact or the data analysis cut-off date, whichever occurred first. As per Flatiron EHR, OS was defined as the time from the index date to the date of death; participants without a date of death were censored at their last known activity date or the end of the follow-up period, whichever occurred first. Index date in each treatment group was defined as the date of treatment initiation. Kaplan-Meier analyses was used for analysis.

Other outcomes

  1. Progression Free Survival (PFS)

    Time frame: COLUMBUS: From date of randomization until death or censoring (approx 80.5 months); Flatiron: From index date until death due or censoring or end of follow-up period (92.7 months)

    COLUMBUS:PFS=time from the date of randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever occurred first; PD:at least 20 percentage (%) increase in the sum of diameter of all measured target lesions, reference to the smallest sum of diameter of all target lesions recorded at or after baseline. In addition, increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimiter square (mm2) or the appearance of 1 or more new lesion, if a participant did not have an event at the analysis cut-off date, PFS was censored at the date of the last adequate tumour assessment. Flatiron:PFS=time from the index date to either the date of first PD event or death in the absence of progression; participants without PD or death were censored at the last date the participant could have been assessed for progression or the data analysis cut-off date, whichever occurred first. Index date was =the date of treatment initiation.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Comparative Effectiveness of Different Targeted Therapies for BRAF-mutated Unresectable/Metastatic Melanoma in the United States

Acronym: OCEANMIST

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 2, 2022
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.