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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

716 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-17

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment Patterns and Outcomes of Targeted Therapy and Immunotherapy Among BRAF-Positive Melanoma Patients Treated in the Adjuvant Setting and Among BRAF-Positive Metastatic Melanoma Patients With Low Tumor Burden

NCT05611229

Metastatic Melanoma

COMPLETED

Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes Among Patients With BRAF-Positive Metastatic Melanoma

NCT06251934

BRAF-positive Metastatic Melanoma

COMPLETED

To Evaluate the Efficacy Beyond Progression of Vemurafenib+Cobimetinib Associated With Local Treatment Compared to Second-line Treatment in Patients With BRAFV600+ Metastatic Melanoma in Focal Progression With First-line+Vemurafenib+Cobimetinib.

NCT03514901

Melanoma Metastatic BRAF V600 Mutation

UNKNOWN PHASE2

Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic

NCT02094872

Recurrent Melanoma Stage IIIA Melanoma Stage IIIB Melanoma +2 more

COMPLETED PHASE2

Overcoming Primary Resistance to Immunotherapy in Metastatic Melanoma

NCT05304546

Malignant Melanoma Metastatic Melanoma Immunotherapy +2 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Melanoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Encorafenib + binimetinib

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

Encorafenib

Intervention Type DRUG

450 mg QD

Binimetinib

Intervention Type DRUG

45 mg BID

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

Vemurafenib

Intervention Type DRUG

960 mg BID for 28 days/cycle

Cobimetinib

Intervention Type DRUG

60 mg QD for 21 days/cycle

Dabrafenib + trametinib

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

Dabrafenib

Intervention Type DRUG

150 mg BID

Trametinib

Intervention Type DRUG

2 mg QD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Encorafenib

450 mg QD

Intervention Type DRUG

Binimetinib

45 mg BID

Intervention Type DRUG

Vemurafenib

960 mg BID for 28 days/cycle

Intervention Type DRUG

Cobimetinib

60 mg QD for 21 days/cycle

Intervention Type DRUG

Dabrafenib

150 mg BID

Intervention Type DRUG

Trametinib

2 mg QD

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Administration route: Oral Administration route: Oral Administration route: Oral Administration route: Oral Administration route: Oral Administration route: Oral

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No