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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
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Key
Inclusion Criteria:
- - Histologically confirmed diagnosis of cutaneous melanoma with metastases to the brain.
- - Presence of B-RAF proto-oncogene, V600 mutant (BRAFV600) mutation in tumor tissue previously determined by a local PCR or NGS-based assay at any time prior to Screening or by a central laboratory during Screening.
- - Must have at least 1 parenchymal brain lesion ≥ 0.5 cm and ≤ 4 cm, defined as a magnetic resonance imaging (MRI) contrast-enhancing lesion that may be accurately measured in at least 1 dimension.
- - Patients may have received the following prior therapies: 1.
- - An Eastern Cooperation Oncology Group Performance Status (ECOG PS) of 0 or 1 and Karnofsky score ≥ 80.
- - Adequate bone marrow, organ function and laboratory parameters.
Exclusion Criteria:
- - Patients with symptomatic brain metastasis.
- - Uveal or mucosal melanoma.
- - History of or current leptomeningeal metastases.
- - Treatment with SRS or craniotomy within 14 days prior to start of study treatment, or treatment with whole-brain radiation within 28 days prior to study treatment.
- - Either of the following: 1.
- - Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 6 months prior to enrollment.
- - Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03911869 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 2 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Pfizer |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Pfizer CT.gov Call Center |
Principal Investigator Affiliation | Pfizer |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
Overall Status | Recruiting |
Countries | Argentina, Australia, Belgium, Canada, Italy, Netherlands, New Zealand, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Brain Metastases |
Study Website: | View Trial Website |
Arms
Experimental: Standard Dose Arm
Patients in the standard-dose treatment arm will receive encorafenib and binimetinib in 28-day cycles. 450 mg encorafenib orally once a day (QD) 45 mg binimetinib orally twice a day (BID) Patients who are able to tolerate the standard dose during the first 4 weeks of treatment (Cycle 1) should be dose-escalated to 600 mg encorafenib QD plus 45 mg binimetinib BID provided they meet protocol-defined criteria.
Experimental: High Dose Arm
Patients in the high-dose treatment arm will receive encorafenib and binimetinib in 28-day cycles. 300 mg encorafenib orally twice a day (BID) 45 mg binimetinib orally twice a day (BID)
Interventions
Drug: - encorafenib
taken orally
Drug: - binimetinib
taken orally
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Not yet recruiting
Address
California Cancer Associates for Research and Excellence
Encinitas, California, 92024
Status
Recruiting
Address
The Angeles Clinic And Research Institute, A Cedars-Sinai Affiliate
Los Angeles, California, 90025
Status
Not yet recruiting
Address
UC Irvine Health
Orange, California, 92868
Status
Not yet recruiting
Address
West Coast Retina
San Francisco, California, 94109
Status
Not yet recruiting
Address
San Francisco Oncology Associates
San Francisco, California, 94115
Status
Recruiting
Address
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
Status
Not yet recruiting
Address
California Cancer Associates for Research and Excellence
San Marcos, California, 92069
Status
Recruiting
Address
The Retina Partners
Santa Monica, California, 90404
Status
Recruiting
Address
Rocky Mountain Lions Eye Institute (RMLEI)
Aurora, Colorado, 80045
Status
Recruiting
Address
University of Colorado Denver CTO/CTRC - Outpatient.
Aurora, Colorado, 80045
Status
Recruiting
Address
University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, 80045
Status
Recruiting
Address
University of Colorado Hospital - Anschutz Outpatient Pavilion
Aurora, Colorado, 80045
Status
Recruiting
Address
University of Colorado Hospital
Aurora, Colorado, 80045
Status
Not yet recruiting
Address
Massachusetts Eye and Ear Infirmary(MEEI)
Boston, Massachusetts, 02114
Status
Not yet recruiting
Address
Ophthalmic Consultants of Boston Inc (OCB)
Boston, Massachusetts, 02114
Status
Not yet recruiting
Address
Massachusetts General Hospital
Boston, Massachusetts, 22114
Status
Not yet recruiting
Address
Kellogg Eye Center - Ann Arbor
Ann Arbor, Michigan, 48105
Status
Not yet recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Not yet recruiting
Address
Siteman Cancer Center - West County
Creve Coeur, Missouri, 63141
Status
Not yet recruiting
Address
St. Luke's Hospital
Kansas City, Missouri, 64111
Status
Not yet recruiting
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110-1032
Status
Not yet recruiting
Address
Barnes-Jewish Hospital
Saint Louis, Missouri, 63110
Status
Not yet recruiting
Address
Washington University Infusion Center Pharmacy
Saint Louis, Missouri, 63110
Status
Not yet recruiting
Address
Siteman Cancer Center - South County
Saint Louis, Missouri, 63129
Status
Recruiting
Address
Bio-Reference Laboratories Inc
Elmwood Park, New Jersey, 07407-3118
Status
Not yet recruiting
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Not yet recruiting
Address
Atlantic Health System, Morristown Medical Center
Morristown, New Jersey, 07962
Status
Not yet recruiting
Address
Metro Eye Care
Paramus, New Jersey, 07417
Status
Not yet recruiting
Address
St Lukes Warren Physician Group Pc
Phillipsburg, New Jersey, 08865
Status
Not yet recruiting
Address
St. Luke's Hospital- Warren Campus
Phillipsburg, New Jersey, 08865
Status
Not yet recruiting
Address
Dr. John M. Boozan, MD
Summit, New Jersey, 07901
Status
Not yet recruiting
Address
Karen Connolly, MD
West Orange, New Jersey, 07052
Status
Not yet recruiting
Address
NYU Investigational Pharmacy
New York, New York, 10016
Status
Not yet recruiting
Address
NYU Langone Faculty Group Practice
New York, New York, 10016
Status
Not yet recruiting
Address
NYU Langone Health
New York, New York, 10016
Status
Not yet recruiting
Address
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43202
Status
Not yet recruiting
Address
Ohio State University James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
Status
Not yet recruiting
Address
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Status
Not yet recruiting
Address
Ohio State Eye and Ear Institute
Columbus, Ohio, 43212
Status
Not yet recruiting
Address
Ohio State University James Cancer Hospital Martha Morehouse Medical Center
Columbus, Ohio, 43221
Status
Recruiting
Address
Knight Cancer Institute Hematology Oncology
Beaverton, Oregon, 97006
Status
Recruiting
Address
Knight Cancer Institute Hematology Oncology - Gresham Clinic
Gresham, Oregon, 97030
Status
Recruiting
Address
Knight Cancer Institute Hematology Oncology - Northwest Clinic
Portland, Oregon, 97210
Status
Recruiting
Address
Kniht acer Intitute Hematology Oncology - East Portland Clinic
Portland, Oregon, 97216
Status
Recruiting
Address
Oregon Health & Science University Center for Health & Healing 2
Portland, Oregon, 97239-3011
Status
Recruiting
Address
OHSU Center for Health and Healing
Portland, Oregon, 97239
Status
Recruiting
Address
OHSU Laboratory Services
Portland, Oregon, 97239
Status
Recruiting
Address
Knight Cancer Institute Hematology Oncology - Tualatin Clinic
Tualatin, Oregon, 97062
Status
Not yet recruiting
Address
St. Luke's Hospital - Allentown Campus
Allentown, Pennsylvania, 18104
Status
Not yet recruiting
Address
St. Luke's Hematology Oncology Specialists
Bethlehem, Pennsylvania, 18015
Status
Not yet recruiting
Address
St. Luke's Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015
Status
Not yet recruiting
Address
Bethlehem Eye Associates
Bethlehem, Pennsylvania, 18018
Status
Not yet recruiting
Address
St. Luke's Hospital- Miners Campus
Coaldale, Pennsylvania, 18218
Status
Not yet recruiting
Address
St. Luke's Hematology Oncology Specialists
Easton, Pennsylvania, 18045
Status
Not yet recruiting
Address
St. Luke's Hospital- Anderson Campus
Easton, Pennsylvania, 18045
Status
Not yet recruiting
Address
UPMC Eye and Ear Institute
Pittsburgh, Pennsylvania, 15213
Status
Not yet recruiting
Address
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Status
Not yet recruiting
Address
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15232
Status
Not yet recruiting
Address
St. Luke's Hospital- Quakertown Campus
Quakertown, Pennsylvania, 18951
Status
Not yet recruiting
Address
St. Luke's Hospital- Monroe Campus
Stroudsburg, Pennsylvania, 18360
Status
Not yet recruiting
Address
Henry-Joyce Cancer Clinic
Nashville, Tennessee, 37232
Status
Recruiting
Address
MD Anderson Cancer Center
Houston, Texas, 77030
Status
Not yet recruiting
Address
University of Utah - Huntsman Cancer Institute - PPDS
Salt Lake City, Utah, 84112-5550
Status
Not yet recruiting
Address
University of Utah, Huntsman Cancer Hospital
Salt Lake City, Utah, 84112
Status
Not yet recruiting
Address
University of Utah, Moran Eye Center
Salt Lake City, Utah, 84132
Status
Not yet recruiting
Address
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792-0001
Status
Not yet recruiting
Address
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
International Sites
Status
Recruiting
Address
Instituto Médico Especializado Alexander Fleming
Buenos Aires, Ciudad Autónoma DE Buenosaires, CP1426ANZ
Status
Recruiting
Address
Iict Labs Sa
Rosario, Santa FE, 2000
Status
Recruiting
Address
Centro de Imágenes Médicas - Clinica de Cámara Gamma
Rosario, Santa FE, S2000AMT
Status
Recruiting
Address
CICOR (rosario)
Rosario, Santa FE, S2000DSK
Status
Recruiting
Address
Instituto de Oncologia de Rosario
Rosario, Santa FE, S2000KZE
Status
Not yet recruiting
Address
Fundacion CIDEA
Caba, , C1121ABE
Status
Recruiting
Address
Micro Cirugia Ocular Rosario
Rosario, ,
Status
Not yet recruiting
Address
Coffs Harbour Health Campus
Coffs Harbour, New South Wales, 2450
Status
Recruiting
Address
Crows Nest Eye Surgery
Crows Nest, New South Wales, 2065
Status
Recruiting
Address
Melanoma Institute Australia
North Sydney, New South Wales, 2060
Status
Recruiting
Address
Royal north shore center hospital dermatology clinics
st Leonards, New South Wales, 2065
Status
Recruiting
Address
Mater Imaging
Wollstonecraft, New South Wales, 2065
Status
Not yet recruiting
Address
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Status
Not yet recruiting
Address
Flinders Medical Centre
Adelaide, South Australia, 5042
Status
Not yet recruiting
Address
South Australian Medical Imaging
Bedford park, South Australia, 5042
Status
Not yet recruiting
Address
Radiology SA
Seacombe Gardens, South Australia, 5047
Status
Not yet recruiting
Address
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Status
Not yet recruiting
Address
Lions Eye Institute
Nedlands, Western Australia, 6009
Status
Not yet recruiting
Address
Affinity Clinical Research
Nedlands, , 6009
Status
Not yet recruiting
Address
Algemeen Ziekenhuis Klina
Brasschaat, Antwerpen, 2930
Status
Not yet recruiting
Address
GasthuisZusters Antwerpen
Wilrijk, Antwerpen, 2610
Status
Recruiting
Address
UZ Antwerpen Pharmacy
Edegem, , 2650
Status
Not yet recruiting
Address
AZ Groeninge
Kortrijk, , 8500
Status
Not yet recruiting
Address
Alberta Cancer Board
Edmonton, Alberta, T5J3N4
Status
Not yet recruiting
Address
Alberta Health Services - Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Status
Not yet recruiting
Address
Health Sciences Centre
Winnepeg, Manitoba, R3A 1R9
Status
Not yet recruiting
Address
St. Boniface Hospital Inc.
Winnepeg, Manitoba, R3E 0V9
Status
Not yet recruiting
Address
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M3
Status
Not yet recruiting
Address
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
Status
Not yet recruiting
Address
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, E3B 5N5
Status
Not yet recruiting
Address
Dipartimento di Tecnologie Avanzate Diagnostico-Terapeutiche - responsible Dr. Angelo Vanzulli
Milano, Milan, 20162
Status
Not yet recruiting
Address
ASST Grande Ospedale Metropolitano Niguarda
Milano, MI, 20162
Status
Recruiting
Address
Azienda Universitaria Policlinico Federico II
Napoli, Naples, 80131
Status
Not yet recruiting
Address
Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
Meldola (FC), Reggio Emilia, 47014
Status
Not yet recruiting
Address
Azienda Ospedale Università Padova - Dipartimento Salute della Donna e del Bambino
Padova, Veneto, 35128
Status
Not yet recruiting
Address
Istituto Oncologico Veneto - I.R.C.C.S.
Padova, Veneto, 35128
Status
Not yet recruiting
Address
Oncologia Medica - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
Servizio di Farmacia - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
Unita Dermatologia e Cosmetologia - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
UO Anatomia Patologica - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
UO Cardiologia - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
UO di Oculistica - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
UO Medicina Nucleare - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
UO Neuro Radiologia - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
UO Radiologia - IRCCS Ospedale San Raffaele S.r.l.
Milano, , 20132
Status
Not yet recruiting
Address
Medicina Nucleare - Dipartimento Tecnologie Avanzate Diagnostico Terapeutiche
Milano, , 20162
Status
Not yet recruiting
Address
S.C Oculistica - Padiglione 3 e/o Blocco Sud, Responsible Dr. Marcelo Pisani
Milano, , 20162
Status
Not yet recruiting
Address
S.C. Cardiologia 4 - Diagnostica e Riabilitativa - Padiglione Blocco SUD responsible Prof. Cristina
Milano, , 20162
Status
Not yet recruiting
Address
SC Farmacia - Polo Logistico - responsible Dr. Massimo Medaglia
Milano, , 20162
Status
Not yet recruiting
Address
Istituto Europeo di Oncologia
Milan, , 20141
Status
Recruiting
Address
S.C. Cardiologia
Napoli, , 80131
Status
Recruiting
Address
S.C. Farmacia
Napoli, , 80131
Status
Recruiting
Address
S.C. Medicina Nucleare e Terapia Metabolica
Napoli, , 80131
Status
Recruiting
Address
SC Melanoma, Immunoterapia Oncologica e Terapie Innovative
Napoli, , 80131
Status
Recruiting
Address
U.O. Radiodiagnostica 1
Napoli, , 80131
Status
Not yet recruiting
Address
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, , 10126
Status
Not yet recruiting
Address
Farmacia Ospedaliera Azienda Ospedaliera Universitaria - Città della Salute e della Scienza di Tori
Torino, , 10126
Status
Not yet recruiting
Address
Medicina Nucleare Azienda Ospedaliera Universitaria
Torino, , 10126
Status
Not yet recruiting
Address
Radiologia 2 Azienda Ospedaliera Universitaria - Città della Salute e della Scienza di Torino
Torino, , 10126
Status
Not yet recruiting
Address
S. C. Dermatologia U Azienda Ospedaliera Universitaria
Torino, , 10126
Status
Not yet recruiting
Address
Oculistica Universitaria Padiglione Dermatologico San Lazzaro Azienda Ospedaliera Universitaria
Torino, , 20126
Status
Not yet recruiting
Address
S.C. MEDICINA INTERNA 4 U Azienda Ospedaliera Universitaria
Torino, , 20126
Status
Not yet recruiting
Address
Medisch Spectrum Twente
Enschede, Overijssel, 7512 KZ
Status
Not yet recruiting
Address
Leids Universitair Medisch Centrum
Leiden, , 2333 ZA
Status
Not yet recruiting
Address
Wellington Hospital
Wellington South, Wellington, 6021
Status
Not yet recruiting
Address
Capital Eye Specialists
Wellington, , 6011