NCT03543969

Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

Pilot Study of Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot early phase I trial studies how well encorafenib, binimetinib, and nivolumab work in treating patients with BRAF mutant stage IIIC-IV melanoma. Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with nivolumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving encorafenib, binimetinib, and nivolumab may kill more tumor cells.

Conditions

• Melanoma (Skin)
• Skin Cancer
• Skin Melanoma
• Skin Carcinoma

Interventions

Type	Name	Description
DRUG	Encorafenib	450 mg encorafenib daily by mouth
DRUG	Binimetinib	45 mg binimetinib daily by mouth
DRUG	Nivolumab	240 mg Nivolumab IV every 2 weeks

Timeline

• Start date: 2018-06-14
• Primary completion: 2024-12-27
• Completion: 2026-12-01
• First posted: 2018-06-01
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study