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

Pfizer logo

Pfizer

Status

Completed

Conditions

Melanoma

Treatments

Drug: Dabrafenib
Drug: Vemurafenib
Drug: Cobimetinib
Drug: Binimetinib
Drug: Trametinib
Drug: Encorafenib

Study type

Observational

Funder types

Industry

Identifiers

NCT05260684
OCEANMIST (Other Identifier)
C4221028

Details and patient eligibility

About

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.

Enrollment

1 patient

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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)

Trial design

1 participants in 3 patient groups

Encorafenib + binimetinib
Description:
Encorafenib 450 mg once a day (QD) Binimetinib 45 mg twice a day (BID)
Treatment:
Drug: Encorafenib
Drug: Binimetinib
Vemurafenib + Cobimetinib
Description:
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
Treatment:
Drug: Vemurafenib
Drug: Cobimetinib
Dabrafenib + trametinib
Description:
Dabrafenib 150 mg twice a day (BID) Trametinib 2 mg once a day (QD)
Treatment:
Drug: Trametinib
Drug: Dabrafenib

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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