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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma
• Intervention / Treatment: Drug: Encorafenib; Drug: Binimetinib; Drug: Vemurafenib; Drug: Cobimetinib; Drug: Dabrafenib; Drug: Trametinib

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10017
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Encorafenib + binimetinib; Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)	Drug: Encorafenib; 450 mg QD; Other Names: Administration route: Oral; Drug: Binimetinib; 45 mg BID; Other Names: Administration route: Oral
Dabrafenib + trametinib; Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)	Drug: Dabrafenib; 150 mg BID; Other Names: Administration route: Oral; Drug: Trametinib; 2 mg QD; Other Names: Administration route: Oral
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; 960 mg BID for 28 days/cycle; Other Names: Administration route: Oral; Drug: Cobimetinib; 60 mg QD for 21 days/cycle; Other Names: Administration route: Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
real-world Overall Survival (rwOS)	Time to event (months). Time from targeted treatment initiation to the date of death due to any cause. Patients without a recorded date of death were censored at their last known activity date (e.g., the last clinical note date) or the end of the follow-up period, whichever occurred first.	From index date to death, assessed up to 52 months
real-world Progression Free Survival (rwPFS)	Time to event (months). Time from targeted treatment initiation to the earliest of date of first disease progression event on targeted treatment or death in the absence of progression. • Patients without disease progression or death while on targeted treatment, or who switch to another therapy were censored at the last date they could have been assessed for progression while on targeted treatment (e.g., the last clinical note date)	From index date to either date of first progression or death, whichever comes first, assessed up to 52 months

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: January 11, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Metastatic melanoma; BRAF-mutant
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Trametinib; Dabrafenib; Vemurafenib
• Other Study ID Numbers: C4221028; OCEANMIST (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.