Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03543969
Phase
EARLY_PHASE1
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Encorafenib — DRUG
    450 mg encorafenib daily by mouth
  • Binimetinib — DRUG
    45 mg binimetinib daily by mouth
  • Nivolumab — DRUG
    240 mg Nivolumab IV every 2 weeks

Study Details

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.

Key Dates

Start date
Jun 14, 2018
Status verified
Feb 2026
Primary completion
Dec 27, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
14 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: BRAF-MEK Inhibitor Therapy
    Participants will receive 450 mg Encorafenib daily, along with 45 mg Binimetinib twice daily and 240 mg Nivolumab IV every 2 weeks.
  • Active Comparator: Arm B
    Participants will receive 240 mg Nivolumab IV every 2 weeks

Primary Outcome Measure

8 Week Completion Rate [ Time Frame: At the end of the first 8 week treatment period ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Skin cancerMelanoma
By specialty
OncologySkin cancerDermatology
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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