A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases
Purpose
This phase II trial compares the effect of encorafenib, binimetinib, and nivolumab versus ipilimumab and nivolumab in treating patients with BRAF- V600 mutant melanoma that has spread to the brain (brain metastases). Encorafenib and binimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Ipilimumab and nivolumab are monoclonal antibodies that may interfere with the ability of tumor cells to grow and spread. This trial aims to find out which approach is more effective in shrinking and controlling brain metastases from melanoma.
Conditions
- Acral Lentiginous Melanoma
- Clinical Stage IV Cutaneous Melanoma AJCC v8
- Metastatic Cutaneous Melanoma
- Metastatic Malignant Neoplasm in the Brain
- Metastatic Melanoma
- Metastatic Mucosal Melanoma
- Pathologic Stage IV Cutaneous Melanoma AJCC v8
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Participants must have histologically and pathologically confirmed melanoma that has metastasized to the brain - Any primary (cutaneous, acral/mucosal, etc) or unknown origin are permitted, except that participants with uveal primary are not eligible - Participants must have BRAF-V600 mutant melanoma documented by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory - All participants must have an magnetic resonance imaging (MRI) of the brain within 28 days prior to registration and must have central nervous system metastases with at least one measurable brain metastasis >= 0.5 cm in size (per modified RECIST 1.1) that has not been irradiated, or progressed (in the opinion of the treating physician) after prior radiation therapy. Participating sites MUST use MRI slice thickness of =< 1.5 mm and are recommended to adhere to the 'minimum' Brain Tumor Imaging Protocol for Clinical Trials in Brain Metastases (BTIP-BM) compliant MRI acquisition protocol. Computed tomography (CT) of the head cannot substitute for brain MRI. (NOTE: All central nervous system [CNS] disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form [RECIST 1.1] using RECIST 1.1.) - Participants may have measurable or non-measurable extracranial disease. All measurable disease must be assessed within 28 days prior to randomization; all non-measurable disease must be assessed within 42 days prior to randomization. Please note, while any extracranial disease will also be assessed and followed, participants are NOT required to have extracranial disease for randomization. NOTE: All disease must be assessed and documented on the Baseline Tumor Assessment Form (RECIST 1.1). CNS disease must be documented on BOTH the Brain Metastases Baseline Tumor Assessment Form, using modified RECIST, and the Baseline Tumor Assessment Form (RECIST 1.1) using RECIST 1.1 - Participants may have leptomeningeal disease - Participants may be receiving corticosteroids for brain metastases at a dose of up to 8 mg of dexamethasone per day. The dose must not have exceeded 8 mg per day for at least 7 days prior to randomization - Participants must have Zubrod performance status =< 2 - Participants must have complete history and physical examination within 28 days prior to randomization - Participants must be able to swallow and retain pills - Hemoglobin >= 8.0 g/dL (within 28 days prior to randomization) - Absolute neutrophil count >= 1,500/mcL (within 28 days prior to randomization) - Platelets >= 75,000/mcL (within 28 days prior to randomization) - Total bilirubin =< 1.5 institutional upper limit of normal (ULN) (within 28 days prior to randomization) - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x institutional ULN (in participants with liver metastases =< 5 x ULN) (within 28 days prior to randomization) - Creatinine =< 2.0 institutional ULN (within 28 days prior to randomization) - Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2B or better - Participants with a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial - Participants with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test and within 90 days prior to randomization - Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with HCV infection who are currently on treatment must have an undetectable HCV viral load prior to randomization - Participants must agree to participate in image banking. Images must be submitted via the Triad System - Participants must be offered the opportunity to participate in specimen and blood collections - Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines - As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
Exclusion Criteria
- Participants must not have received prior systemic therapy for metastatic disease. Prior systemic therapy received only in the neoadjuvant and/or adjuvant setting (e.g., BRAF/MEK inhibitor therapy, anti-PD-1 therapy or anti-CTLA4 therapy, alfa-interferon, etc.) is permitted. If patients received prior neoadjuvant/adjuvant therapy, they must have had eventual disease relapse prior to randomization - Participants must not have had prior radiation therapy within 7 days prior to randomization - Participants must not be planning to require any additional form of systemic anti-tumor therapy for melanoma while on protocol treatment - Participants must not be planning to use hormonal contraceptives - Participants must not have a serious active infection requiring systemic therapy at time of randomization in the opinion of the treating physician - Participants must not have active autoimmune disease that has required treatment in the past 6 months with use of biologic disease modifying agents (.e.g. infliximab, adalimumab). Patients on non-biologic disease modifying agents (e.g. methotrexate) or patients on corticosteroids =< 10 mg prednisone daily or equivalent (to treat auto-immune disease), or on replacement therapy (e.g., thyroxine, insulin) are eligible if deemed in the best interest of the patient by treating physician - Participants must not have had grade 3 or 4 immune-related adverse events on ipilimumab or nivolumab that required more than 12 weeks of immune suppression with corticosteroids - Participants must not have had adverse events related to encorafenib and/or binimetinib specifically, that required discontinuation of one or both drugs. (Please note this does not apply to other BRAF/MEK inhibitor drugs.) - Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective method of contraception. (NOTE: Patients must agree to not use hormonal contraceptives, as encorafenib can result in decreased concentration and loss of efficacy.) A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm I (encorafenib, binimetinib, nivolumab) |
Patients receive encorafenib PO QD on days 1-28, binimetinib PO BID on days 1-28, and nivolumab IV on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
|
|
Experimental Arm II (nivolumab, ipilimumab) |
Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity. |
|
Recruiting Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
Birmingham, Alabama 35233
Thomas Hospital
Fairhope, Alabama 36532
Fairhope, Alabama 36532
Contact:
Site Public Contact
251-435-4584
Site Public Contact
251-435-4584
Mobile Infirmary Medical Center
Mobile, Alabama 36607
Mobile, Alabama 36607
Contact:
Site Public Contact
251-435-3942
Site Public Contact
251-435-3942
Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508
Anchorage, Alaska 98508
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504
Anchorage, Alaska 99504
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Alaska Women's Cancer Care
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage Oncology Centre
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Katmai Oncology Group
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Providence Alaska Medical Center
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Fairbanks Memorial Hospital
Fairbanks, Alaska 99701
Fairbanks, Alaska 99701
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Fort Smith, Arkansas 72903
Contact:
Site Public Contact
800-378-9373
Site Public Contact
800-378-9373
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505
Burbank, California 91505
Epic Care-Dublin
Dublin, California 94568
Dublin, California 94568
Contact:
Site Public Contact
925-875-1677
Site Public Contact
925-875-1677
Bay Area Breast Surgeons Inc
Emeryville, California 94608
Emeryville, California 94608
Contact:
Site Public Contact
510-835-9900
Site Public Contact
510-835-9900
Epic Care Partners in Cancer Care
Emeryville, California 94608
Emeryville, California 94608
Contact:
Site Public Contact
510-629-6682
Site Public Contact
510-629-6682
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California 90095
Los Angeles, California 90095
Contact:
Site Public Contact
888-798-0719
Site Public Contact
888-798-0719
Contra Costa Regional Medical Center
Martinez, California 94553-3156
Martinez, California 94553-3156
Contact:
Site Public Contact
925-957-5400
Site Public Contact
925-957-5400
Providence Queen of The Valley
Napa, California 94558
Napa, California 94558
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Bay Area Tumor Institute
Oakland, California 94609
Oakland, California 94609
Sharp Memorial Hospital
San Diego, California 92123
San Diego, California 92123
Providence Medical Foundation - Santa Rosa
Santa Rosa, California 95403
Santa Rosa, California 95403
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Providence Santa Rosa Memorial Hospital
Santa Rosa, California 95405
Santa Rosa, California 95405
Contact:
Site Public Contact
707-521-3830
Site Public Contact
707-521-3830
Epic Care Cyberknife Center
Walnut Creek, California 94597
Walnut Creek, California 94597
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado 80012
Aurora, Colorado 80012
University of Colorado Hospital
Aurora, Colorado 80045
Aurora, Colorado 80045
Contact:
Site Public Contact
720-848-0650
Site Public Contact
720-848-0650
Boulder Community Foothills Hospital
Boulder, Colorado 80303
Boulder, Colorado 80303
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado 80304
Boulder, Colorado 80304
Rocky Mountain Cancer Centers - Centennial
Centennial, Colorado 80112
Centennial, Colorado 80112
The Women's Imaging Center
Denver, Colorado 80209
Denver, Colorado 80209
Colorado Blood Cancer Institute
Denver, Colorado 80218
Denver, Colorado 80218
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado 80218
Denver, Colorado 80218
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado 80218
Denver, Colorado 80218
Rocky Mountain Cancer Centers-Rose
Denver, Colorado 80220
Denver, Colorado 80220
Mountain Blue Cancer Care Center - Swedish
Englewood, Colorado 80113
Englewood, Colorado 80113
Rocky Mountain Cancer Centers - Swedish
Englewood, Colorado 80113
Englewood, Colorado 80113
Swedish Medical Center
Englewood, Colorado 80113
Englewood, Colorado 80113
The Melanoma and Skin Cancer Institute
Englewood, Colorado 80113
Englewood, Colorado 80113
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228
Lakewood, Colorado 80228
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado 80120
Littleton, Colorado 80120
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260
Thornton, Colorado 80260
Orlando Health Cancer Institute
Orlando, Florida 32806
Orlando, Florida 32806
Moffitt Cancer Center-International Plaza
Tampa, Florida 33607
Tampa, Florida 33607
Moffitt Cancer Center - McKinley Campus
Tampa, Florida 33612
Tampa, Florida 33612
Moffitt Cancer Center
Tampa, Florida 33612
Tampa, Florida 33612
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
Boise, Idaho 83706
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
Boise, Idaho 83712
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
Caldwell, Idaho 83605
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
Coeur d'Alene, Idaho 83814
Walter Knox Memorial Hospital
Emmett, Idaho 83617
Emmett, Idaho 83617
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
Fruitland, Idaho 83619
Idaho Urologic Institute-Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
Meridian, Idaho 83642
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83686
Nampa, Idaho 83686
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
Nampa, Idaho 83687
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
Post Falls, Idaho 83854
Kootenai Cancer Clinic
Sandpoint, Idaho 83864
Sandpoint, Idaho 83864
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
Twin Falls, Idaho 83301
Saint Anthony's Health
Alton, Illinois 62002
Alton, Illinois 62002
Contact:
Site Public Contact
618-463-5623
Site Public Contact
618-463-5623
Rush - Copley Medical Center
Aurora, Illinois 60504
Aurora, Illinois 60504
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Carbondale, Illinois 62902
SIH Cancer Institute
Carterville, Illinois 62918
Carterville, Illinois 62918
Illinois CancerCare-Carthage
Carthage, Illinois 62321
Carthage, Illinois 62321
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Illinois CancerCare-Dixon
Dixon, Illinois 61021
Dixon, Illinois 61021
Contact:
Site Public Contact
815-285-7800
Site Public Contact
815-285-7800
Carle Physician Group-Effingham
Effingham, Illinois 62401
Effingham, Illinois 62401
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Illinois CancerCare-Eureka
Eureka, Illinois 61530
Eureka, Illinois 61530
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Contact:
Site Public Contact
309-344-2831
Site Public Contact
309-344-2831
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
Kewanee, Illinois 61443
Illinois CancerCare-Macomb
Macomb, Illinois 61455
Macomb, Illinois 61455
Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864
Mount Vernon, Illinois 62864
Contact:
Site Public Contact
618-242-4600
Site Public Contact
618-242-4600
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
Ottawa, Illinois 61350
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Methodist Medical Center of Illinois
Peoria, Illinois 61636
Peoria, Illinois 61636
Illinois CancerCare-Peru
Peru, Illinois 61354
Peru, Illinois 61354
Valley Radiation Oncology
Peru, Illinois 61354
Peru, Illinois 61354
Contact:
Site Public Contact
815-664-4141
Site Public Contact
815-664-4141
Illinois CancerCare-Princeton
Princeton, Illinois 61356
Princeton, Illinois 61356
Southern Illinois University School of Medicine
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
217-545-7929
Site Public Contact
217-545-7929
Springfield Clinic
Springfield, Illinois 62702
Springfield, Illinois 62702
Contact:
Site Public Contact
800-444-7541
Site Public Contact
800-444-7541
Memorial Medical Center
Springfield, Illinois 62781
Springfield, Illinois 62781
Carle Cancer Center
Urbana, Illinois 61801
Urbana, Illinois 61801
The Carle Foundation Hospital
Urbana, Illinois 61801
Urbana, Illinois 61801
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Rush-Copley Healthcare Center
Yorkville, Illinois 60560
Yorkville, Illinois 60560
Reid Health
Richmond, Indiana 47374
Richmond, Indiana 47374
Mary Greeley Medical Center
Ames, Iowa 50010
Ames, Iowa 50010
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Ames
Ames, Iowa 50010
Ames, Iowa 50010
McFarland Clinic - Boone
Boone, Iowa 50036
Boone, Iowa 50036
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Saint Anthony Regional Hospital
Carroll, Iowa 51401
Carroll, Iowa 51401
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-6727
Site Public Contact
515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Contact:
Site Public Contact
515-241-3305
Site Public Contact
515-241-3305
Broadlawns Medical Center
Des Moines, Iowa 50314
Des Moines, Iowa 50314
Contact:
Site Public Contact
515-282-2200
Site Public Contact
515-282-2200
Iowa Lutheran Hospital
Des Moines, Iowa 50316
Des Moines, Iowa 50316
Contact:
Site Public Contact
515-241-8704
Site Public Contact
515-241-8704
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Trinity Regional Medical Center
Fort Dodge, Iowa 50501
Fort Dodge, Iowa 50501
Contact:
Site Public Contact
515-574-8302
Site Public Contact
515-574-8302
McFarland Clinic - Jefferson
Jefferson, Iowa 50129
Jefferson, Iowa 50129
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
Marshalltown, Iowa 50158
Contact:
Site Public Contact
515-956-4132
Site Public Contact
515-956-4132
Methodist West Hospital
West Des Moines, Iowa 50266-7700
West Des Moines, Iowa 50266-7700
Contact:
Site Public Contact
515-343-1000
Site Public Contact
515-343-1000
Central Care Cancer Center - Garden City
Garden City, Kansas 67846
Garden City, Kansas 67846
Central Care Cancer Center - Great Bend
Great Bend, Kansas 67530
Great Bend, Kansas 67530
Mercy Health - Paducah Medical Oncology and Hematology
Paducah, Kentucky 42003
Paducah, Kentucky 42003
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
Bronson Battle Creek
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
University of Michigan - Brighton Center for Specialty Care
Brighton, Michigan 48116
Brighton, Michigan 48116
Contact:
Site Public Contact
800-865-1125
Site Public Contact
800-865-1125
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
West Michigan Cancer Center
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
Ascension Borgess Cancer Center
Kalamazoo, Michigan 49009
Kalamazoo, Michigan 49009
Borgess Medical Center
Kalamazoo, Michigan 49048
Kalamazoo, Michigan 49048
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
Muskegon, Michigan 49444
Lakeland Hospital Niles
Niles, Michigan 49120
Niles, Michigan 49120
Contact:
Site Public Contact
616-391-1230
Site Public Contact
616-391-1230
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
Norton Shores, Michigan 49444
Spectrum Health Reed City Hospital
Reed City, Michigan 49677
Reed City, Michigan 49677
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
Saint Joseph, Michigan 49085
Munson Medical Center
Traverse City, Michigan 49684
Traverse City, Michigan 49684
University of Michigan Health - West
Wyoming, Michigan 49519
Wyoming, Michigan 49519
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Cambridge Medical Center
Cambridge, Minnesota 55008
Cambridge, Minnesota 55008
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Unity Hospital
Fridley, Minnesota 55432
Fridley, Minnesota 55432
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
Maple Grove, Minnesota 55369
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Health Partners Inc
Minneapolis, Minnesota 55454
Minneapolis, Minnesota 55454
Monticello Cancer Center
Monticello, Minnesota 55362
Monticello, Minnesota 55362
New Ulm Medical Center
New Ulm, Minnesota 56073
New Ulm, Minnesota 56073
Fairview Northland Medical Center
Princeton, Minnesota 55371
Princeton, Minnesota 55371
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
Robbinsdale, Minnesota 55422
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55102
Saint Paul, Minnesota 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
Lakeview Hospital
Stillwater, Minnesota 55082
Stillwater, Minnesota 55082
Ridgeview Medical Center
Waconia, Minnesota 55387
Waconia, Minnesota 55387
Rice Memorial Hospital
Willmar, Minnesota 56201
Willmar, Minnesota 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Woodbury, Minnesota 55125
Fairview Lakes Medical Center
Wyoming, Minnesota 55092
Wyoming, Minnesota 55092
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Ballwin, Missouri 63011
Contact:
Site Public Contact
314-251-7058
Site Public Contact
314-251-7058
Central Care Cancer Center - Bolivar
Bolivar, Missouri 65613
Bolivar, Missouri 65613
Cox Cancer Center Branson
Branson, Missouri 65616
Branson, Missouri 65616
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Southeast Cancer Center
Cape Girardeau, Missouri 63703
Cape Girardeau, Missouri 63703
Contact:
Site Public Contact
573-651-5550
Site Public Contact
573-651-5550
Parkland Health Center - Farmington
Farmington, Missouri 63640
Farmington, Missouri 63640
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Capital Region Southwest Campus
Jefferson City, Missouri 65109
Jefferson City, Missouri 65109
Freeman Health System
Joplin, Missouri 64804
Joplin, Missouri 64804
Mercy Hospital Joplin
Joplin, Missouri 64804
Joplin, Missouri 64804
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri 65401
Rolla, Missouri 65401
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri 65401
Rolla, Missouri 65401
Contact:
Site Public Contact
573-458-6379
Site Public Contact
573-458-6379
Heartland Regional Medical Center
Saint Joseph, Missouri 64506
Saint Joseph, Missouri 64506
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
Sainte Genevieve, Missouri 63670
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
CoxHealth South Hospital
Springfield, Missouri 65807
Springfield, Missouri 65807
Contact:
Site Public Contact
417-269-4520
Site Public Contact
417-269-4520
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri 63109
St Louis, Missouri 63109
Contact:
Site Public Contact
314-353-1870
Site Public Contact
314-353-1870
Missouri Baptist Medical Center
St Louis, Missouri 63131
St Louis, Missouri 63131
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Saint Louis
St Louis, Missouri 63141
St Louis, Missouri 63141
Contact:
Site Public Contact
314-251-7066
Site Public Contact
314-251-7066
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
Sullivan, Missouri 63080
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri 63127
Sunset Hills, Missouri 63127
Contact:
Site Public Contact
314-996-5569
Site Public Contact
314-996-5569
Mercy Hospital Washington
Washington, Missouri 63090
Washington, Missouri 63090
Contact:
Site Public Contact
636-390-1600
Site Public Contact
636-390-1600
Community Hospital of Anaconda
Anaconda, Montana 59711
Anaconda, Montana 59711
Billings Clinic Cancer Center
Billings, Montana 59101
Billings, Montana 59101
Bozeman Deaconess Hospital
Bozeman, Montana 59715
Bozeman, Montana 59715
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana 59405
Great Falls, Montana 59405
Great Falls Clinic
Great Falls, Montana 59405
Great Falls, Montana 59405
Kalispell Regional Medical Center
Kalispell, Montana 59901
Kalispell, Montana 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana 59802
Missoula, Montana 59802
Community Medical Hospital
Missoula, Montana 59804
Missoula, Montana 59804
Cancer Partners of Nebraska - Pine Lake
Lincoln, Nebraska 68516
Lincoln, Nebraska 68516
Southeast Nebraska Cancer Center - 68th Street Place
Lincoln, Nebraska 68516
Lincoln, Nebraska 68516
Wake Forest University at Clemmons
Clemmons, North Carolina 27012
Clemmons, North Carolina 27012
Contact:
Site Public Contact
888-716-9259
Site Public Contact
888-716-9259
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
Clinton, North Carolina 28328
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
Goldsboro, North Carolina 27534
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
Jacksonville, North Carolina 28546
Wake Forest Baptist Health - Hematology Oncology - Statesville
Statesville, North Carolina 28677
Statesville, North Carolina 28677
Contact:
Site Public Contact
704-872-3630
Site Public Contact
704-872-3630
Wake Forest Baptist Health - Wilkes Medical Center
Wilkesboro, North Carolina 28659
Wilkesboro, North Carolina 28659
Contact:
Site Public Contact
888-716-9253
Site Public Contact
888-716-9253
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
Winston-Salem, North Carolina 27157
Contact:
Site Public Contact
336-713-6771
Site Public Contact
336-713-6771
UHHS-Chagrin Highlands Medical Center
Beachwood, Ohio 44122
Beachwood, Ohio 44122
Indu and Raj Soin Medical Center
Beavercreek, Ohio 45431
Beavercreek, Ohio 45431
Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Belpre, Ohio 45714
Saint Elizabeth Boardman Hospital
Boardman, Ohio 44512
Boardman, Ohio 44512
Dayton Physicians LLC-Miami Valley South
Centerville, Ohio 45459
Centerville, Ohio 45459
Geauga Hospital
Chardon, Ohio 44024
Chardon, Ohio 44024
Adena Regional Medical Center
Chillicothe, Ohio 45601
Chillicothe, Ohio 45601
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio 45236
Cincinnati, Ohio 45236
Case Western Reserve University
Cleveland, Ohio 44106
Cleveland, Ohio 44106
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Mount Carmel East Hospital
Columbus, Ohio 43213
Columbus, Ohio 43213
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio 43214
Columbus, Ohio 43214
Riverside Methodist Hospital
Columbus, Ohio 43214
Columbus, Ohio 43214
Grant Medical Center
Columbus, Ohio 43215
Columbus, Ohio 43215
The Mark H Zangmeister Center
Columbus, Ohio 43219
Columbus, Ohio 43219
Mount Carmel Health Center West
Columbus, Ohio 43222
Columbus, Ohio 43222
Doctors Hospital
Columbus, Ohio 43228
Columbus, Ohio 43228
Dayton Physician LLC-Miami Valley Hospital North
Dayton, Ohio 45415
Dayton, Ohio 45415
Delaware Health Center-Grady Cancer Center
Delaware, Ohio 43015
Delaware, Ohio 43015
Grady Memorial Hospital
Delaware, Ohio 43015
Delaware, Ohio 43015
Columbus Oncology and Hematology Associates
Dublin, Ohio 43016
Dublin, Ohio 43016
Dublin Methodist Hospital
Dublin, Ohio 43016
Dublin, Ohio 43016
Armes Family Cancer Center
Findlay, Ohio 45840
Findlay, Ohio 45840
Blanchard Valley Hospital
Findlay, Ohio 45840
Findlay, Ohio 45840
Orion Cancer Care
Findlay, Ohio 45840
Findlay, Ohio 45840
Dayton Physicians LLC-Atrium
Franklin, Ohio 45005
Franklin, Ohio 45005
Central Ohio Breast and Endocrine Surgery
Gahanna, Ohio 43230
Gahanna, Ohio 43230
Dayton Physicians LLC-Wayne
Greenville, Ohio 45331
Greenville, Ohio 45331
Wayne Hospital
Greenville, Ohio 45331
Greenville, Ohio 45331
Mount Carmel Grove City Hospital
Grove City, Ohio 43123
Grove City, Ohio 43123
Zangmeister Center Grove City
Grove City, Ohio 43123
Grove City, Ohio 43123
Greater Dayton Cancer Center
Kettering, Ohio 45409
Kettering, Ohio 45409
Kettering Medical Center
Kettering, Ohio 45429
Kettering, Ohio 45429
Fairfield Medical Center
Lancaster, Ohio 43130
Lancaster, Ohio 43130
Saint Rita's Medical Center
Lima, Ohio 45801
Lima, Ohio 45801
Contact:
Site Public Contact
419-226-9617
Site Public Contact
419-226-9617
OhioHealth Mansfield Hospital
Mansfield, Ohio 44903
Mansfield, Ohio 44903
Marietta Memorial Hospital
Marietta, Ohio 45750
Marietta, Ohio 45750
OhioHealth Marion General Hospital
Marion, Ohio 43302
Marion, Ohio 43302
UH Seidman Cancer Center at Southwest General Hospital
Middleburg Heights, Ohio 44130
Middleburg Heights, Ohio 44130
Knox Community Hospital
Mount Vernon, Ohio 43050
Mount Vernon, Ohio 43050
Mount Carmel New Albany Surgical Hospital
New Albany, Ohio 43054
New Albany, Ohio 43054
Licking Memorial Hospital
Newark, Ohio 43055
Newark, Ohio 43055
Newark Radiation Oncology
Newark, Ohio 43055
Newark, Ohio 43055
University Hospitals Parma Medical Center
Parma, Ohio 44129
Parma, Ohio 44129
Mercy Health Perrysburg Cancer Center
Perrysburg, Ohio 43551
Perrysburg, Ohio 43551
Southern Ohio Medical Center
Portsmouth, Ohio 45662
Portsmouth, Ohio 45662
University Hospitals Portage Medical Center
Ravenna, Ohio 44266
Ravenna, Ohio 44266
UH Seidman Cancer Center at Firelands Regional Medical Center
Sandusky, Ohio 44870
Sandusky, Ohio 44870
Springfield Regional Cancer Center
Springfield, Ohio 45504
Springfield, Ohio 45504
Springfield Regional Medical Center
Springfield, Ohio 45505
Springfield, Ohio 45505
Saint Vincent Mercy Medical Center
Toledo, Ohio 43608
Toledo, Ohio 43608
Mercy Health - Saint Anne Hospital
Toledo, Ohio 43623
Toledo, Ohio 43623
Dayton Physicians LLC - Troy
Troy, Ohio 45373
Troy, Ohio 45373
University Hospitals Sharon Health Center
Wadsworth, Ohio 44281
Wadsworth, Ohio 44281
Saint Joseph Warren Hospital
Warren, Ohio 44484
Warren, Ohio 44484
Saint Ann's Hospital
Westerville, Ohio 43081
Westerville, Ohio 43081
UH Seidman Cancer Center at Saint John Medical Center
Westlake, Ohio 44145
Westlake, Ohio 44145
Saint Elizabeth Youngstown Hospital
Youngstown, Ohio 44501
Youngstown, Ohio 44501
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio 43701
Zanesville, Ohio 43701
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
Oklahoma City, Oklahoma 73104
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma 73120
Oklahoma City, Oklahoma 73120
Contact:
Site Public Contact
405-752-3402
Site Public Contact
405-752-3402
Saint Alphonsus Medical Center-Baker City
Baker City, Oregon 97814
Baker City, Oregon 97814
Saint Charles Health System
Bend, Oregon 97701
Bend, Oregon 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Providence Cancer Institute Clackamas Clinic
Clackamas, Oregon 97015
Clackamas, Oregon 97015
Bay Area Hospital
Coos Bay, Oregon 97420
Coos Bay, Oregon 97420
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Saint Alphonsus Medical Center-Ontario
Ontario, Oregon 97914
Ontario, Oregon 97914
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
Oregon City, Oregon 97045
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Saint Charles Health System-Redmond
Redmond, Oregon 97756
Redmond, Oregon 97756
Contact:
Site Public Contact
541-706-2909
Site Public Contact
541-706-2909
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
Pittsburgh, Pennsylvania 15232
Contact:
Site Public Contact
412-647-8073
Site Public Contact
412-647-8073
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
Salt Lake City, Utah 84112
Providence Regional Cancer System-Aberdeen
Aberdeen, Washington 98520
Aberdeen, Washington 98520
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
Bellingham, Washington 98225
Contact:
Site Public Contact
360-788-8223
Site Public Contact
360-788-8223
Providence Regional Cancer System-Centralia
Centralia, Washington 98531
Centralia, Washington 98531
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
Edmonds, Washington 98026
Providence Regional Cancer Partnership
Everett, Washington 98201
Everett, Washington 98201
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
Issaquah, Washington 98029
Kadlec Clinic Hematology and Oncology
Kennewick, Washington 99336
Kennewick, Washington 99336
Providence Regional Cancer System-Lacey
Lacey, Washington 98503
Lacey, Washington 98503
PeaceHealth Saint John Medical Center
Longview, Washington 98632
Longview, Washington 98632
Jefferson Healthcare
Port Townsend, Washington 98368
Port Townsend, Washington 98368
Contact:
Site Public Contact
360-344-3091
Site Public Contact
360-344-3091
Swedish Medical Center-Ballard Campus
Seattle, Washington 98107
Seattle, Washington 98107
Swedish Medical Center-Cherry Hill
Seattle, Washington 98122-5711
Seattle, Washington 98122-5711
Swedish Medical Center-First Hill
Seattle, Washington 98122
Seattle, Washington 98122
PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
Sedro-Woolley, Washington 98284
Providence Regional Cancer System-Shelton
Shelton, Washington 98584
Shelton, Washington 98584
PeaceHealth Southwest Medical Center
Vancouver, Washington 98664
Vancouver, Washington 98664
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington 99362
Walla Walla, Washington 99362
Providence Regional Cancer System-Yelm
Yelm, Washington 98597
Yelm, Washington 98597
Langlade Hospital and Cancer Center
Antigo, Wisconsin 54409
Antigo, Wisconsin 54409
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
La Crosse, Wisconsin 54601
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
Madison, Wisconsin 53792
Contact:
Site Public Contact
800-622-8922
Site Public Contact
800-622-8922
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
Marshfield, Wisconsin 54449
Aspirus Medford Hospital
Medford, Wisconsin 54451
Medford, Wisconsin 54451
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin 54548
Minocqua, Wisconsin 54548
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin 54868
Rice Lake, Wisconsin 54868
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin 54481
Stevens Point, Wisconsin 54481
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
Stevens Point, Wisconsin 54482
Aspirus Regional Cancer Center
Wausau, Wisconsin 54401
Wausau, Wisconsin 54401
Contact:
Site Public Contact
877-405-6866
Site Public Contact
877-405-6866
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
Weston, Wisconsin 54476
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids, Wisconsin 54494
Wisconsin Rapids, Wisconsin 54494
Contact:
Site Public Contact
715-422-7718
Site Public Contact
715-422-7718
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming 82001
Cheyenne, Wyoming 82001
Billings Clinic-Cody
Cody, Wyoming 82414
Cody, Wyoming 82414
Welch Cancer Center
Sheridan, Wyoming 82801
Sheridan, Wyoming 82801
More Details
- Status
- Recruiting
- Sponsor
- SWOG Cancer Research Network
Detailed Description
PRIMARY OBJECTIVE: I. To compare progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 between participants randomized to the triplet combination of encorafenib + binimetinib + nivolumab versus the doublet combination of ipilimumab + nivolumab among participants with BRAF-V600 mutant melanoma that has metastasized to the brain. SECONDARY OBJECTIVES: I. To estimate the overall survival (OS) of participants in each treatment arm. II. To estimate the objective response rate (ORR) (confirmed and unconfirmed, complete and partial responses) per RECIST 1.1 in each treatment arm. III. To estimate the intracranial response rate (ICRR), defined as confirmed and unconfirmed complete and partial response per modified RECIST for brain metastases (mRECIST). IV. To evaluate the duration of response, per RECIST 1.1 and the duration of ICRR per mRECIST, and per Response Assessment in Neuro-Oncology (RANO)-Brain Metastases (BM) (and immunotherapy [i]RANO) in each treatment arm. V. To evaluate the toxicity profile of each treatment arm. VI. To evaluate current and emerging radiographic response criteria (modified RECIST 1.1, modified RANO-BM and iRANO) by a retrospective blinded independent centralized review (BICR) of banked images. BANKING OBJECTIVE: I. To bank tumor tissue, cerebral spinal fluid (CSF), stool and blood samples for future correlative studies. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive encorafenib orally (PO) once daily (QD) on days 1-28, binimetinib PO twice daily (BID) on days 1-28, and nivolumab intravenously (IV) on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive nivolumab IV on day 1 of all cycles and ipilimumab IV over 30 minutes on day 1 of cycles 1-4. Cycles repeat every 21 days for 4 cycles and then every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 2 years, and then annually until 3 years after randomization.