IRB #

STUDY00019667

Title

A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis

Principal Investigator

Matthew Taylor

Study Purpose

The purpose of this research study is to determine if high dose versus standard-dose regimens of encorafenib and binimetinib are safe and have positive effects in people who have melanoma brain metastasis and also have been found by their doctor to have a mutated gene called BRAFV600.

Medical Condition(s)

Metastatic melanoma that has spread to the brain
Melanoma with BRAFV600 mutation

Eligibility Criteria

Male and Female participants of 18 years of age and older.
Metastatic melanoma that has spread to the brain
Melanoma with BRAFV600 mutation

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

The length of your participation in this study will depend on how long you receive the study drugs. After you stop treatment, you will be asked to come to the clinic for a safety follow-up visit. The visit will be about 30 days after stopping the study drugs. After the safety follow up visit, you will move into the follow-up period and will be contacted by telephone, email, or site visit every 12 weeks to check for any possible new serious adverse events, record all subsequent anticancer therapies, and to check on your long-term health status.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Array Biopharmac Inc.

Recruitment End

10/31/2020

Compensation Provided

No


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