An 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
Stopped early · Phase 2
Conditions studied: Brain Metastases
In brief
This is a multicenter, randomized open-label Phase 2 study to assess the safety, efficacy and pharmacokinetic (PK) of 2 dosing regimens of encorafenib + binimetinib combination in patients with BRAFV600-mutant melanoma with brain metastasis. Approximately 100 patients will be enrolled, including 9 patients in a Safety Lead-in of the high-dose treatment arm. After a Screening Period, treatment will be administered in 28-day cycles and will continue until disease progression, unacceptable toxicity, withdrawal of consent, start of subsequent anticancer therapy, death.
Key facts
- Study ID
- NCT03911869
- Run by
- Pfizer
- People needed
- 13
- Starts
- 2019-04-30
- Expected to finish
- 2022-01-27
- Last updated by the study team
- 2023-05-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate — Los Angeles, California, United States
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
- The Retina Partners — Santa Monica, California, United States
- Rocky Mountain Lions Eye Institute (RMLEI) — Aurora, Colorado, United States
- University of Colorado Denver CTO/CTRC - Outpatient. — Aurora, Colorado, United States
- University of Colorado Hospital - Anschutz Cancer Pavilion (ACP) — Aurora, Colorado, United States
- University of Colorado Hospital - Anschutz Outpatient Pavilion — Aurora, Colorado, United States
- University of Colorado Hospital — Aurora, Colorado, United States
- Oregon Health & Science University Center for Health & Healing 2 — Portland, Oregon, United States
- OHSU Center for Health and Healing — Portland, Oregon, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Instituto Médico Especializado Alexander Fleming — Buenos Aires, Ciudad Autónoma de Buenosaires, Argentina
- Instituto de Oncologia de Rosario — Rosario, Santa Fe Province, Argentina
- Fundacion CIDEA — CABA, Argentina
- Crows Nest Eye Surgery — Crows Nest, New South Wales, Australia
- Melanoma Institute Australia — North Sydney, New South Wales, Australia
- Royal north shore center hospital dermatology clinics — St Leonards, New South Wales, Australia
- Mater Imaging — Wollstonecraft, New South Wales, Australia
- UZ Antwerpen — Edegem, Antwerpen, Belgium
- Azienda Universitaria Policlinico Federico II — Naples, Naples, Italy
- S.C. Cardiologia — Naples, Italy
- S.C. Farmacia — Naples, Italy
- S.C. Medicina Nucleare e Terapia Metabolica — Naples, Italy
- SC Melanoma, Immunoterapia Oncologica e Terapie Innovative — Naples, Italy
- U.O. Radiodiagnostica 1 — Naples, Italy
Full record on ClinicalTrials.gov
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