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

NCT05260684 | Completed Results

• 2 other identifiers: C4221028OCEANMIST
• Study Type: observational
• Target: 716
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma

Keywords

BRAF-mutant; Metastatic melanoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  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.

  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)

Other Outcomes (1)

• Progression Free Survival (PFS)

  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)

Study Arms (3)

Encorafenib + binimetinib

Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)

Drug: Encorafenib; Drug: Binimetinib

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

Drug: Vemurafenib; Drug: Cobimetinib

Dabrafenib + trametinib

Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)

Drug: Dabrafenib; Drug: Trametinib

Interventions

Encorafenib DRUG

450 mg QD

Also known as: Administration route: Oral

Encorafenib + binimetinib

Binimetinib DRUG

45 mg BID

Also known as: Administration route: Oral

Encorafenib + binimetinib

Vemurafenib DRUG

960 mg BID for 28 days/cycle

Also known as: Administration route: Oral

Vemurafenib + Cobimetinib

Cobimetinib DRUG

60 mg QD for 21 days/cycle

Also known as: Administration route: Oral

Vemurafenib + Cobimetinib

Dabrafenib DRUG

150 mg BID

Also known as: Administration route: Oral

Dabrafenib + trametinib

Trametinib DRUG

2 mg QD

Also known as: Administration route: Oral

Dabrafenib + trametinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be metastatic melanoma patients receiving targeted combination therapies derived from an anonymized Flatiron Health data combined with patient data from COLUMBUS trial data

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New York, New York, 10017, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Melanoma

Interventions

encorafenib; Drug Administration Routes; binimetinib; Vemurafenib; cobimetinib; dabrafenib; trametinib

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: March 2, 2022
• Study Start: January 17, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)