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

Part of paid clinical trials in New York, New York.

Sponsor
Pfizer
Study ID
NCT05260684
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Encorafenib — DRUG
    450 mg QD
  • Binimetinib — DRUG
    45 mg BID
  • Vemurafenib — DRUG
    960 mg BID for 28 days/cycle
  • Cobimetinib — DRUG
    60 mg QD for 21 days/cycle
  • Dabrafenib — DRUG
    150 mg BID
  • Trametinib — DRUG
    2 mg QD

Study Details

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.

Key Dates

Start date
Jan 17, 2022
Status verified
Mar 2025
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
716 participants (actual)

Arms

  • Arm: Encorafenib + binimetinib
    Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)
  • Arm: Vemurafenib + Cobimetinib
    Vemurafenib 960 mg twice a day (BID) for 28 days of 28 day cycle Cobimetinib 60 mg once a day (QD) for 21 days of 28 day cycle
  • Arm: Dabrafenib + trametinib
    Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)

Primary Outcome Measure

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Pfizer Investigational SiteNew YorkNew York10017-

Find similar trials in New York, NY

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Pfizer Investigational Site· New York, NY

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