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Adaptive BRAF-MEK Inhibitor Therapy for Advanced BRAF Mutant Melanoma

NCT03543969 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2026-02-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Zeynep Eroglu, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-14
Primary Completion
2024-12-27
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03543969 on ClinicalTrials.gov