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

Melanoma Clinical Trial

— OCEANMIST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05260684
• Other study ID #: C4221028
• Secondary ID: OCEANMIST
• Status: Completed
• Start date: January 17, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Melanoma

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

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