Binimetinib and Encorafenib for the Treatment of Metastatic Melanoma and Central Nervous System Metastases
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT05026983
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Metastatic Melanoma
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Binimetinib — DRUGGiven PO
- Encorafenib — DRUGGiven PO
- Questionnaire Administration — OTHERAncillary studies
Study Details
This phase II trial studies the effects of binimetinib and encorafenib in treating patients with melanoma that has spread to the central nervous system (metastases). Binimetinib and encorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving binimetinib and encorafenib may help control melanoma that has spread to the brain.
Key Dates
- Start date
- Dec 27, 2021
- Status verified
- Apr 2026
- Primary completion
- Feb 2, 2027
- Completion
- Feb 2, 2027
Study Design
- Enrollment
- 35 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (encorafenib, binimetinib)Patients receive encorafenib PO QD and binimetinib PO BID on day 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure
Progression free survival (PFS) (Cohort A) [ Time Frame: At 3 months ]
Central Contacts
- Isabella C Glitza, MD,PHD713-792-2921
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | Isabella C. Glitza, MD (PRINCIPAL_INVESTIGATOR) |
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