A Study to Compare the Administration of Encorafenib + Binimetinib + Nivolumab Versus Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

August 11, 2023 updated by: SWOG Cancer Research Network

A Randomized Phase 2 Trial of Encorafenib + Binimetinib + Nivolumab vs Ipilimumab + Nivolumab in BRAF-V600 Mutant Melanoma With Brain Metastases

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Principal Investigator:
          • Maya Khalil
        • Contact:
      • Fairhope, Alabama, United States, 36532
        • Recruiting
        • Thomas Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 251-435-4584
        • Principal Investigator:
          • Furhan Yunus
      • Mobile, Alabama, United States, 36607
        • Recruiting
        • Mobile Infirmary Medical Center
        • Principal Investigator:
          • Furhan Yunus
        • Contact:
          • Site Public Contact
          • Phone Number: 251-435-3942
    • Alaska
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 98508
      • Anchorage, Alaska, United States, 99504
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Anchorage, Alaska, United States, 99508
      • Fairbanks, Alaska, United States, 99701
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Recruiting
        • Mercy Hospital Fort Smith
        • Contact:
          • Site Public Contact
          • Phone Number: 800-378-9373
        • Principal Investigator:
          • Jay W. Carlson
    • California
      • Burbank, California, United States, 91505
        • Recruiting
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Dublin, California, United States, 94568
        • Recruiting
        • Epic Care-Dublin
        • Contact:
          • Site Public Contact
          • Phone Number: 925-875-1677
        • Principal Investigator:
          • Lisa Bailey
      • Emeryville, California, United States, 94608
        • Recruiting
        • Bay Area Breast Surgeons Inc
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
          • Site Public Contact
          • Phone Number: 510-835-9900
      • Emeryville, California, United States, 94608
        • Recruiting
        • Epic Care Partners in Cancer Care
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
          • Site Public Contact
          • Phone Number: 510-629-6682
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA / Jonsson Comprehensive Cancer Center
        • Principal Investigator:
          • Bartosz Chmielowski
        • Contact:
          • Site Public Contact
          • Phone Number: 888-798-0719
      • Martinez, California, United States, 94553-3156
        • Recruiting
        • Contra Costa Regional Medical Center
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
          • Site Public Contact
          • Phone Number: 925-957-5400
      • Napa, California, United States, 94558
        • Recruiting
        • Providence Queen of The Valley
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Oakland, California, United States, 94609
        • Suspended
        • Alta Bates Summit Medical Center - Summit Campus
      • Oakland, California, United States, 94609
        • Recruiting
        • Bay Area Tumor Institute
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • Sharp Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Charles H. Redfern
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation - Santa Rosa
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Santa Rosa, California, United States, 95405
        • Recruiting
        • Providence Santa Rosa Memorial Hospital
        • Principal Investigator:
          • Charles W. Drescher
        • Contact:
          • Site Public Contact
          • Phone Number: 707-521-3830
      • Walnut Creek, California, United States, 94597
        • Recruiting
        • Epic Care Cyberknife Center
        • Principal Investigator:
          • Lisa Bailey
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Principal Investigator:
          • Theresa M. Medina
        • Contact:
          • Site Public Contact
          • Phone Number: 720-848-0650
      • Aurora, Colorado, United States, 80012
        • Suspended
        • The Medical Center of Aurora
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Rocky Mountain Cancer Centers-Aurora
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers-Boulder
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Boulder, Colorado, United States, 80303
        • Recruiting
        • Boulder Community Foothills Hospital
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Centennial, Colorado, United States, 80112
        • Recruiting
        • Rocky Mountain Cancer Centers - Centennial
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Suspended
        • Rose Medical Center
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers-Midtown
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Recruiting
        • Rocky Mountain Cancer Centers-Rose
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80220
        • Suspended
        • Western Surgical Care
      • Denver, Colorado, United States, 80209
        • Recruiting
        • The Women's Imaging Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Presbyterian - Saint Lukes Medical Center - Health One
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Mountain Blue Cancer Care Center - Swedish
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Rocky Mountain Cancer Centers - Swedish
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Englewood, Colorado, United States, 80113
        • Recruiting
        • Swedish Medical Center
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Englewood, Colorado, United States, 80113
      • Greeley, Colorado, United States, 80631
        • Suspended
        • North Colorado Medical Center
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Rocky Mountain Cancer Centers-Lakewood
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Littleton, Colorado, United States, 80120
        • Recruiting
        • Rocky Mountain Cancer Centers-Littleton
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Lone Tree, Colorado, United States, 80124
        • Suspended
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, United States, 80124
        • Recruiting
        • Rocky Mountain Cancer Centers-Sky Ridge
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Loveland, Colorado, United States, 80539
        • Suspended
        • McKee Medical Center
      • Thornton, Colorado, United States, 80260
        • Recruiting
        • Rocky Mountain Cancer Centers-Thornton
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
    • Florida
      • Aventura, Florida, United States, 33180
        • Active, not recruiting
        • UM Sylvester Comprehensive Cancer Center at Aventura
      • Coral Gables, Florida, United States, 33146
        • Active, not recruiting
        • UM Sylvester Comprehensive Cancer Center at Coral Gables
      • Deerfield Beach, Florida, United States, 33442
        • Active, not recruiting
        • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
      • Miami, Florida, United States, 33136
        • Active, not recruiting
        • University of Miami Miller School of Medicine-Sylvester Cancer Center
      • Miami, Florida, United States, 33176
        • Active, not recruiting
        • UM Sylvester Comprehensive Cancer Center at Kendall
      • Orlando, Florida, United States, 32806
      • Plantation, Florida, United States, 33324
        • Active, not recruiting
        • UM Sylvester Comprehensive Cancer Center at Plantation
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Moffitt Cancer Center-International Plaza
        • Principal Investigator:
          • Zeynep Eroglu
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center - McKinley Campus
        • Principal Investigator:
          • Zeynep Eroglu
        • Contact:
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Principal Investigator:
          • Zeynep Eroglu
        • Contact:
    • Georgia
      • Savannah, Georgia, United States, 31405
        • Active, not recruiting
        • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
    • Idaho
      • Boise, Idaho, United States, 83712
        • Recruiting
        • Saint Luke's Cancer Institute - Boise
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Boise, Idaho, United States, 83706
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Boise
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Caldwell, Idaho, United States, 83605
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Coeur d'Alene, Idaho, United States, 83814
        • Recruiting
        • Kootenai Health - Coeur d'Alene
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Emmett, Idaho, United States, 83617
        • Recruiting
        • Walter Knox Memorial Hospital
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Fruitland, Idaho, United States, 83619
        • Recruiting
        • Saint Luke's Cancer Institute - Fruitland
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Idaho Urologic Institute-Meridian
        • Contact:
        • Principal Investigator:
          • John M. Schallenkamp
      • Meridian, Idaho, United States, 83642
        • Recruiting
        • Saint Luke's Cancer Institute - Meridian
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Nampa, Idaho, United States, 83686
        • Recruiting
        • Saint Luke's Cancer Institute - Nampa
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Nampa, Idaho, United States, 83687
        • Recruiting
        • Saint Alphonsus Cancer Care Center-Nampa
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Kootenai Clinic Cancer Services - Post Falls
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sandpoint, Idaho, United States, 83864
        • Recruiting
        • Kootenai Cancer Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Twin Falls, Idaho, United States, 83301
        • Recruiting
        • Saint Luke's Cancer Institute - Twin Falls
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Illinois
      • Alton, Illinois, United States, 62002
        • Recruiting
        • Saint Anthony's Health
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-463-5623
      • Aurora, Illinois, United States, 60504
        • Recruiting
        • Rush - Copley Medical Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Illinois CancerCare-Bloomington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Canton, Illinois, United States, 61520
        • Recruiting
        • Illinois CancerCare-Canton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Carbondale, Illinois, United States, 62902
        • Recruiting
        • Memorial Hospital of Carbondale
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carterville, Illinois, United States, 62918
        • Recruiting
        • SIH Cancer Institute
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Carthage, Illinois, United States, 62321
        • Recruiting
        • Illinois CancerCare-Carthage
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Saint Mary's Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Active, not recruiting
        • Northwestern University
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Decatur Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Dixon, Illinois, United States, 61021
        • Recruiting
        • Illinois CancerCare-Dixon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-285-7800
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Eureka, Illinois, United States, 61530
        • Recruiting
        • Illinois CancerCare-Eureka
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Illinois CancerCare-Galesburg
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Galesburg, Illinois, United States, 61401
        • Recruiting
        • Western Illinois Cancer Treatment Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 309-344-2831
      • Kewanee, Illinois, United States, 61443
        • Recruiting
        • Illinois CancerCare-Kewanee Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Lake Forest, Illinois, United States, 60045
        • Active, not recruiting
        • Northwestern Medicine Lake Forest Hospital
      • Macomb, Illinois, United States, 61455
        • Recruiting
        • Illinois CancerCare-Macomb
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Mount Vernon, Illinois, United States, 62864
        • Recruiting
        • Good Samaritan Regional Health Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 618-242-4600
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Ottawa, Illinois, United States, 61350
        • Recruiting
        • Illinois CancerCare-Ottawa Clinic
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Pekin, Illinois, United States, 61554
        • Recruiting
        • Illinois CancerCare-Pekin
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61615
        • Recruiting
        • Illinois CancerCare-Peoria
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peoria, Illinois, United States, 61636
        • Recruiting
        • Methodist Medical Center of Illinois
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Illinois CancerCare-Peru
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Peru, Illinois, United States, 61354
        • Recruiting
        • Valley Radiation Oncology
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 815-664-4141
      • Princeton, Illinois, United States, 61356
        • Recruiting
        • Illinois CancerCare-Princeton
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Springfield Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 800-444-7541
      • Springfield, Illinois, United States, 62781
        • Recruiting
        • Memorial Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Swansea, Illinois, United States, 62226
        • Suspended
        • Southwest Illinois Health Services LLP
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • The Carle Foundation Hospital
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Washington, Illinois, United States, 61571
        • Recruiting
        • Illinois CancerCare - Washington
        • Contact:
        • Principal Investigator:
          • Bryan A. Faller
      • Yorkville, Illinois, United States, 60560
        • Recruiting
        • Rush-Copley Healthcare Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
    • Indiana
      • Richmond, Indiana, United States, 47374
        • Recruiting
        • Reid Health
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Recruiting
        • McFarland Clinic - Boone
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Carroll, Iowa, United States, 51401
        • Recruiting
        • Saint Anthony Regional Hospital
        • Contact:
        • Principal Investigator:
          • Joshua Lukenbill
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Medical Oncology and Hematology Associates-Des Moines
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-3305
      • Des Moines, Iowa, United States, 50314
        • Recruiting
        • Broadlawns Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-282-2200
      • Des Moines, Iowa, United States, 50309
        • Recruiting
        • Iowa Methodist Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-6727
      • Des Moines, Iowa, United States, 50316
        • Recruiting
        • Iowa Lutheran Hospital
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-241-8704
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • Trinity Regional Medical Center
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-574-8302
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Recruiting
        • McFarland Clinic - Jefferson
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • West Des Moines, Iowa, United States, 50266-7700
        • Recruiting
        • Methodist West Hospital
        • Principal Investigator:
          • Joshua Lukenbill
        • Contact:
          • Site Public Contact
          • Phone Number: 515-343-1000
    • Kansas
      • Garden City, Kansas, United States, 67846
        • Recruiting
        • Central Care Cancer Center - Garden City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Great Bend, Kansas, United States, 67530
        • Recruiting
        • Central Care Cancer Center - Great Bend
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Recruiting
        • Mercy Health - Paducah Medical Oncology and Hematology
        • Contact:
        • Principal Investigator:
          • Nicholas DiBella
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Comprehensive Cancer Center
        • Principal Investigator:
          • Christopher D. Lao
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Brighton, Michigan, United States, 48116
        • Recruiting
        • University of Michigan - Brighton Center for Specialty Care
        • Principal Investigator:
          • Christopher D. Lao
        • Contact:
          • Site Public Contact
          • Phone Number: 800-865-1125
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Helen DeVos Children's Hospital at Spectrum Health
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Spectrum Health at Butterworth Campus
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Ascension Borgess Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49048
        • Recruiting
        • Borgess Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Niles, Michigan, United States, 49120
        • Recruiting
        • Lakeland Hospital Niles
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
          • Site Public Contact
          • Phone Number: 616-391-1230
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Principal Investigator:
          • Kathleen J. Yost
        • Contact:
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Spectrum Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Lakeland Medical Center Saint Joseph
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • David M. King
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Fairview Ridges Hospital
      • Cambridge, Minnesota, United States, 55008
        • Recruiting
        • Cambridge Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Fridley, Minnesota, United States, 55432
        • Recruiting
        • Unity Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • David M. King
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • David M. King
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Recruiting
        • Saint Louis Cancer and Breast Institute-Ballwin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7058
      • Bolivar, Missouri, United States, 65613
        • Recruiting
        • Central Care Cancer Center - Bolivar
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Branson, Missouri, United States, 65616
        • Recruiting
        • Cox Cancer Center Branson
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Saint Francis Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-334-2230
          • Email: sfmc@sfmc.net
      • Cape Girardeau, Missouri, United States, 63703
        • Recruiting
        • Southeast Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 573-651-5550
      • Farmington, Missouri, United States, 63640
        • Recruiting
        • Parkland Health Center - Farmington
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Jefferson City, Missouri, United States, 65109
        • Recruiting
        • Capital Region Southwest Campus
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Freeman Health System
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Joplin, Missouri, United States, 64804
        • Recruiting
        • Mercy Hospital Joplin
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Delbert Day Cancer Institute at PCRMC
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Rolla, Missouri, United States, 65401
        • Recruiting
        • Mercy Clinic-Rolla-Cancer and Hematology
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 573-458-6379
      • Saint Joseph, Missouri, United States, 64506
        • Recruiting
        • Heartland Regional Medical Center
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Saint Louis, Missouri, United States, 63141
        • Recruiting
        • Mercy Hospital Saint Louis
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-251-7066
      • Saint Louis, Missouri, United States, 63131
        • Recruiting
        • Missouri Baptist Medical Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Saint Louis, Missouri, United States, 63109
        • Recruiting
        • Saint Louis Cancer and Breast Institute-South City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 314-353-1870
      • Saint Louis, Missouri, United States, 63128
        • Recruiting
        • Mercy Hospital South
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
      • Sainte Genevieve, Missouri, United States, 63670
        • Recruiting
        • Sainte Genevieve County Memorial Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Springfield, Missouri, United States, 65804
        • Recruiting
        • Mercy Hospital Springfield
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • CoxHealth South Hospital
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 417-269-4520
      • Sullivan, Missouri, United States, 63080
        • Recruiting
        • Missouri Baptist Sullivan Hospital
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Sunset Hills, Missouri, United States, 63127
        • Recruiting
        • Missouri Baptist Outpatient Center-Sunset Hills
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
          • Site Public Contact
          • Phone Number: 314-996-5569
      • Washington, Missouri, United States, 63090
        • Recruiting
        • Mercy Hospital Washington
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 636-390-1600
    • Montana
      • Anaconda, Montana, United States, 59711
        • Recruiting
        • Community Hospital of Anaconda
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bozeman, Montana, United States, 59715
        • Recruiting
        • Bozeman Deaconess Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Benefis Healthcare- Sletten Cancer Institute
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Great Falls Clinic
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Kalispell, Montana, United States, 59901
        • Recruiting
        • Kalispell Regional Medical Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Community Medical Hospital
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Missoula, Montana, United States, 59802
        • Recruiting
        • Saint Patrick Hospital - Community Hospital
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Cancer Partners of Nebraska - Pine Lake
        • Contact:
        • Principal Investigator:
          • Joni A. Tilford
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Southeast Nebraska Cancer Center - 68th Street Place
        • Contact:
        • Principal Investigator:
          • Joni A. Tilford
    • New York
      • Buffalo, New York, United States, 14263
        • Active, not recruiting
        • Roswell Park Cancer Institute
    • North Carolina
      • Clemmons, North Carolina, United States, 27012
        • Recruiting
        • Wake Forest University at Clemmons
        • Contact:
          • Site Public Contact
          • Phone Number: 888-716-9259
        • Principal Investigator:
          • Pierre L. Triozzi
      • Clinton, North Carolina, United States, 28328
        • Recruiting
        • Southeastern Medical Oncology Center-Clinton
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Goldsboro, North Carolina, United States, 27534
        • Recruiting
        • Southeastern Medical Oncology Center-Goldsboro
        • Contact:
        • Principal Investigator:
          • Samer S. Kasbari
      • Jacksonville, North Carolina, United States, 28546
        • Recruiting
        • Southeastern Medical Oncology Center-Jacksonville
        • Principal Investigator:
          • Samer S. Kasbari
        • Contact:
      • Statesville, North Carolina, United States, 28677
        • Recruiting
        • Wake Forest Baptist Health - Hematology Oncology - Statesville
        • Contact:
          • Site Public Contact
          • Phone Number: 704-872-3630
        • Principal Investigator:
          • Pierre L. Triozzi
      • Wilkesboro, North Carolina, United States, 28659
        • Recruiting
        • Wake Forest Baptist Health - Wilkes Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 888-716-9253
        • Principal Investigator:
          • Pierre L. Triozzi
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:
          • Site Public Contact
          • Phone Number: 336-713-6771
        • Principal Investigator:
          • Pierre L. Triozzi
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Recruiting
        • UHHS-Chagrin Highlands Medical Center
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Beavercreek, Ohio, United States, 45431
        • Recruiting
        • Indu and Raj Soin Medical Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Belpre, Ohio, United States, 45714
        • Recruiting
        • Strecker Cancer Center-Belpre
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Boardman, Ohio, United States, 44512
        • Recruiting
        • Saint Elizabeth Boardman Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Centerville, Ohio, United States, 45459
        • Recruiting
        • Dayton Physicians LLC-Miami Valley South
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Centerville, Ohio, United States, 45459
        • Suspended
        • Miami Valley Hospital South
      • Chardon, Ohio, United States, 44024
        • Recruiting
        • Geauga Hospital
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Chillicothe, Ohio, United States, 45601
        • Recruiting
        • Adena Regional Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Oncology Hematology Care Inc-Kenwood
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Cincinnati, Ohio, United States, 45219
        • Active, not recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Mount Carmel East Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Columbus Oncology and Hematology Associates Inc
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • Riverside Methodist Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Grant Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43219
        • Recruiting
        • The Mark H Zangmeister Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43222
        • Recruiting
        • Mount Carmel Health Center West
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43228
        • Recruiting
        • Doctors Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Principal Investigator:
          • Kari L. Kendra
        • Contact:
      • Dayton, Ohio, United States, 45415
        • Recruiting
        • Dayton Physician LLC-Miami Valley Hospital North
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Dayton, Ohio, United States, 45409
        • Suspended
        • Miami Valley Hospital
      • Dayton, Ohio, United States, 45415
        • Suspended
        • Miami Valley Hospital North
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Delaware Health Center-Grady Cancer Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Delaware, Ohio, United States, 43015
        • Recruiting
        • Grady Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Columbus Oncology and Hematology Associates
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Dublin Methodist Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Findlay, Ohio, United States, 45840
        • Recruiting
        • Armes Family Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Findlay, Ohio, United States, 45840
        • Recruiting
        • Blanchard Valley Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Findlay, Ohio, United States, 45840
        • Recruiting
        • Orion Cancer Care
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Franklin, Ohio, United States, 45005
        • Recruiting
        • Dayton Physicians LLC-Atrium
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Franklin, Ohio, United States, 45005-1066
        • Suspended
        • Atrium Medical Center-Middletown Regional Hospital
      • Gahanna, Ohio, United States, 43230
        • Recruiting
        • Central Ohio Breast and Endocrine Surgery
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Dayton Physicians LLC-Wayne
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Greenville, Ohio, United States, 45331
        • Recruiting
        • Wayne Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Grove City, Ohio, United States, 43123
        • Recruiting
        • Mount Carmel Grove City Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Grove City, Ohio, United States, 43123
        • Recruiting
        • Zangmeister Center Grove City
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Kettering, Ohio, United States, 45409
        • Recruiting
        • Greater Dayton Cancer Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Kettering, Ohio, United States, 45429
        • Recruiting
        • Kettering Medical Center
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Lancaster, Ohio, United States, 43130
        • Recruiting
        • Fairfield Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Lima, Ohio, United States, 45801
        • Recruiting
        • Saint Rita's Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
          • Site Public Contact
          • Phone Number: 419-226-9617
      • Mansfield, Ohio, United States, 44903
        • Recruiting
        • OhioHealth Mansfield Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Marietta, Ohio, United States, 45750
        • Recruiting
        • Marietta Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Marion, Ohio, United States, 43302
        • Recruiting
        • OhioHealth Marion General Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • UH Seidman Cancer Center at Southwest General Hospital
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Mount Vernon, Ohio, United States, 43050
        • Recruiting
        • Knox Community Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • New Albany, Ohio, United States, 43054
        • Recruiting
        • Mount Carmel New Albany Surgical Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Newark, Ohio, United States, 43055
        • Recruiting
        • Licking Memorial Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Newark, Ohio, United States, 43055
        • Recruiting
        • Newark Radiation Oncology
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Parma, Ohio, United States, 44129
        • Recruiting
        • University Hospitals Parma Medical Center
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Perrysburg, Ohio, United States, 43551
        • Recruiting
        • Mercy Health Perrysburg Cancer Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Portsmouth, Ohio, United States, 45662
        • Recruiting
        • Southern Ohio Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Ravenna, Ohio, United States, 44266
        • Recruiting
        • University Hospitals Portage Medical Center
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Sandusky, Ohio, United States, 44870
        • Recruiting
        • UH Seidman Cancer Center at Firelands Regional Medical Center
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Springfield, Ohio, United States, 45504
        • Recruiting
        • Springfield Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Springfield, Ohio, United States, 45505
        • Recruiting
        • Springfield Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Timothy D. Moore
      • Toledo, Ohio, United States, 43608
        • Recruiting
        • Saint Vincent Mercy Medical Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Mercy Health - Saint Anne Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Troy, Ohio, United States, 45373
        • Suspended
        • Upper Valley Medical Center
      • Troy, Ohio, United States, 45373
        • Recruiting
        • Dayton Physicians LLC - Troy
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Wadsworth, Ohio, United States, 44281
        • Recruiting
        • University Hospitals Sharon Health Center
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Warren, Ohio, United States, 44484
        • Recruiting
        • Saint Joseph Warren Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • West Chester, Ohio, United States, 45069
        • Active, not recruiting
        • University of Cincinnati Cancer Center-West Chester
      • Westerville, Ohio, United States, 43081
        • Recruiting
        • Saint Ann's Hospital
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
      • Westlake, Ohio, United States, 44145
        • Recruiting
        • UH Seidman Cancer Center at Saint John Medical Center
        • Principal Investigator:
          • Ankit Mangla
        • Contact:
      • Youngstown, Ohio, United States, 44501
        • Recruiting
        • Saint Elizabeth Youngstown Hospital
        • Contact:
        • Principal Investigator:
          • Howard M. Gross
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis Healthcare System Cancer Care Center
        • Principal Investigator:
          • Timothy D. Moore
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • University of Oklahoma Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Abdul Rafeh Naqash
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Mercy Hospital Oklahoma City
        • Principal Investigator:
          • Jay W. Carlson
        • Contact:
          • Site Public Contact
          • Phone Number: 405-752-3402
    • Oregon
      • Baker City, Oregon, United States, 97814
        • Recruiting
        • Saint Alphonsus Medical Center-Baker City
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Bend, Oregon, United States, 97701
        • Recruiting
        • Saint Charles Health System
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Providence Cancer Institute Clackamas Clinic
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Clackamas, Oregon, United States, 97015
        • Recruiting
        • Clackamas Radiation Oncology Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Coos Bay, Oregon, United States, 97420
        • Recruiting
        • Bay Area Hospital
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Newberg, Oregon, United States, 97132
        • Recruiting
        • Providence Newberg Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Ontario, Oregon, United States, 97914
        • Recruiting
        • Saint Alphonsus Medical Center-Ontario
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Oregon City, Oregon, United States, 97045
        • Recruiting
        • Providence Willamette Falls Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Redmond, Oregon, United States, 97756
        • Recruiting
        • Saint Charles Health System-Redmond
        • Contact:
          • Site Public Contact
          • Phone Number: 541-706-2909
        • Principal Investigator:
          • Charles W. Drescher
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • University of Pittsburgh Cancer Institute (UPCI)
        • Principal Investigator:
          • Yana Najjar
        • Contact:
          • Site Public Contact
          • Phone Number: 412-647-8073
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Active, not recruiting
        • Avera Cancer Institute
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Joanne M. Jeter
    • Washington
      • Aberdeen, Washington, United States, 98520
        • Recruiting
        • Providence Regional Cancer System-Aberdeen
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Bellingham, Washington, United States, 98225
        • Recruiting
        • PeaceHealth Saint Joseph Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 360-788-8223
        • Principal Investigator:
          • Charles W. Drescher
      • Centralia, Washington, United States, 98531
        • Recruiting
        • Providence Regional Cancer System-Centralia
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Edmonds, Washington, United States, 98026
        • Recruiting
        • Swedish Cancer Institute-Edmonds
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Everett, Washington, United States, 98201
        • Recruiting
        • Providence Regional Cancer Partnership
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Issaquah, Washington, United States, 98029
        • Recruiting
        • Swedish Cancer Institute-Issaquah
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Oncology
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System-Lacey
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Longview, Washington, United States, 98632
        • Recruiting
        • PeaceHealth Saint John Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Port Townsend, Washington, United States, 98368
        • Recruiting
        • Jefferson Healthcare
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
          • Site Public Contact
          • Phone Number: 360-344-3091
      • Seattle, Washington, United States, 98104
        • Suspended
        • Pacific Gynecology Specialists
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center-First Hill
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98107
        • Recruiting
        • Swedish Medical Center-Ballard Campus
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Seattle, Washington, United States, 98122-5711
        • Recruiting
        • Swedish Medical Center-Cherry Hill
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Sedro-Woolley, Washington, United States, 98284
        • Recruiting
        • PeaceHealth United General Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Shelton, Washington, United States, 98584
        • Recruiting
        • Providence Regional Cancer System-Shelton
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Vancouver, Washington, United States, 98664
        • Recruiting
        • PeaceHealth Southwest Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Walla Walla, Washington, United States, 99362
        • Recruiting
        • Providence Saint Mary Regional Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Yelm, Washington, United States, 98597
        • Recruiting
        • Providence Regional Cancer System-Yelm
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Wisconsin
      • Antigo, Wisconsin, United States, 54409
        • Recruiting
        • Langlade Hospital and Cancer Center
        • Contact:
        • Principal Investigator:
          • Andrew J. Huang
      • Eau Claire, Wisconsin, United States, 54701
      • La Crosse, Wisconsin, United States, 54601
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • David E. Marinier
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
        • Principal Investigator:
          • Vincent T. Ma
      • Marshfield, Wisconsin, United States, 54449
      • Medford, Wisconsin, United States, 54451
        • Recruiting
        • Aspirus Medford Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Minocqua, Wisconsin, United States, 54548
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King
      • Rice Lake, Wisconsin, United States, 54868
      • Stevens Point, Wisconsin, United States, 54482
      • Stevens Point, Wisconsin, United States, 54481
        • Recruiting
        • Ascension Saint Michael's Hospital
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
      • Wausau, Wisconsin, United States, 54401
        • Recruiting
        • Aspirus Regional Cancer Center
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 877-405-6866
      • Weston, Wisconsin, United States, 54476
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Recruiting
        • Aspirus Cancer Care - Wisconsin Rapids
        • Principal Investigator:
          • Andrew J. Huang
        • Contact:
          • Site Public Contact
          • Phone Number: 715-422-7718
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Recruiting
        • Cheyenne Regional Medical Center-West
        • Principal Investigator:
          • Nicholas DiBella
        • Contact:
      • Cody, Wyoming, United States, 82414
        • Recruiting
        • Billings Clinic-Cody
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:
      • Sheridan, Wyoming, United States, 82801
        • Recruiting
        • Welch Cancer Center
        • Principal Investigator:
          • John M. Schallenkamp
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
Drug: Binimetinib
Given PO
Other Names:
  • ARRY-162
  • ARRY-438162
  • MEK162
  • Mektovi
Drug: Encorafenib
Given PO
Other Names:
  • Braftovi
  • LGX 818
  • LGX-818
  • LGX818
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.
Biological: Nivolumab
Given IV
Other Names:
  • BMS-936558
  • MDX-1106
  • NIVO
  • ONO-4538
  • Opdivo
Biological: Ipilimumab
Given IV
Other Names:
  • Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody
  • BMS-734016
  • MDX-010
  • MDX-CTLA4
  • Yervoy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: From date of registration to date of first documentation of progression, or symptomatic deterioration, or death due to any cause, assessed up to 3 years after randomization
Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
From date of registration to date of first documentation of progression, or symptomatic deterioration, or death due to any cause, assessed up to 3 years after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: From date of registration to date of death due to any cause, assessed up to 3 years after randomization
Will be assessed by Immunotherapy Response Assessment Criteria for Intracranial Metastases (RANO-BM). Will construct Kaplan-Meier plots and estimate the median OS and construct 95% Brookmeyer-Crowley Confidence intervals.
From date of registration to date of death due to any cause, assessed up to 3 years after randomization
Intracranial response rate (ICRR)
Time Frame: Up to 3 years after randomization
The ICRR is defined as the best response when applying modified (m)RECIST criteria. Will compare intracranial response based on assessments per mRECIST, RANO-BM and immunotherapy (i)RANO criteria based on a review of the banked images. For each of these methods, the best response to treatment will be summarized by treatment arm, the percent agreement between each pair of methods will be reported along with a 95% confidence interval, and a p-value based on a two-sided McNemar's test will be calculated.
Up to 3 years after randomization
Objective response rate
Time Frame: Up to 3 years after randomization
Will be assessed by RECIST 1.1.
Up to 3 years after randomization
Duration of response
Time Frame: Up to 3 years after randomization
Up to 3 years after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Zeynep Eroglu, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2021

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2000 (Other Identifier: CTEP)
  • U10CA180888 (U.S. NIH Grant/Contract)
  • NCI-2020-05496 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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