RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-01-06

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04511013

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Catrina Mireles

CONTACT

2106148808

cmireles@swog.org

Dana Sparks

CONTACT

12106148808

dsparks@swog.org

Principal Investigator

Zeynep Eroglu

PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Study Locations (Sites)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

United States

Thomas Hospital

Fairhope, Alabama, 36532

United States

Mobile Infirmary Medical Center

Mobile, Alabama, 36607

United States

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508

United States

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504

United States

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508

United States

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508

United States

Alaska Women's Cancer Care

Anchorage, Alaska, 99508

United States

Anchorage Oncology Centre

Anchorage, Alaska, 99508

United States

Katmai Oncology Group

Anchorage, Alaska, 99508

United States

Providence Alaska Medical Center

Anchorage, Alaska, 99508

United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, 99701

United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903

United States

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505

United States

Epic Care-Dublin

Dublin, California, 94568

United States

Bay Area Breast Surgeons Inc

Emeryville, California, 94608

United States

Epic Care Partners in Cancer Care

Emeryville, California, 94608

United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095

United States

Contra Costa Regional Medical Center

Martinez, California, 94553-3156

United States

Providence Queen of The Valley

Napa, California, 94558

United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609

United States

Bay Area Tumor Institute

Oakland, California, 94609

United States

Sharp Memorial Hospital

San Diego, California, 92123

United States

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, 95403

United States

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, 95405

United States

Epic Care Cyberknife Center

Walnut Creek, California, 94597

United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012

United States

The Medical Center of Aurora

Aurora, Colorado, 80012

United States

University of Colorado Hospital

Aurora, Colorado, 80045

United States

Boulder Community Foothills Hospital

Boulder, Colorado, 80303

United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304

United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, 80112

United States

The Women's Imaging Center

Denver, Colorado, 80209

United States

Colorado Blood Cancer Institute

Denver, Colorado, 80218

United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, 80218

United States

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, 80218

United States

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, 80220

United States

Rose Medical Center

Denver, Colorado, 80220

United States

Western Surgical Care

Denver, Colorado, 80220

United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, 80113

United States

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, 80113

United States

Swedish Medical Center

Englewood, Colorado, 80113

United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado, 80113

United States

North Colorado Medical Center

Greeley, Colorado, 80631

United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, 80228

United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, 80120

United States

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, 80124

United States

Sky Ridge Medical Center

Lone Tree, Colorado, 80124

United States

McKee Medical Center

Loveland, Colorado, 80539

United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, 80260

United States

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180

United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146

United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442

United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136

United States

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, 33176

United States

Orlando Health Cancer Institute

Orlando, Florida, 32806

United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, 33324

United States

Moffitt Cancer Center-International Plaza

Tampa, Florida, 33607

United States

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, 33612

United States

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405

United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, 83706

United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, 83605

United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, 83814

United States

Walter Knox Memorial Hospital

Emmett, Idaho, 83617

United States

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, 83642

United States

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

United States

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83686

United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, 83854

United States

Kootenai Cancer Clinic

Sandpoint, Idaho, 83864

United States

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

United States

Saint Anthony's Health

Alton, Illinois, 62002

United States

Rush - Copley Medical Center

Aurora, Illinois, 60504

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

United States

Illinois CancerCare-Canton

Canton, Illinois, 61520

United States

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902

United States

SIH Cancer Institute

Carterville, Illinois, 62918

United States

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

United States

Centralia Oncology Clinic

Centralia, Illinois, 62801

United States

Saint Mary's Hospital

Centralia, Illinois, 62801

United States

Northwestern University

Chicago, Illinois, 60611

United States

Carle at The Riverfront

Danville, Illinois, 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

United States

Decatur Memorial Hospital

Decatur, Illinois, 62526

United States

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

United States

Carle Physician Group-Effingham

Effingham, Illinois, 62401

United States

Crossroads Cancer Center

Effingham, Illinois, 62401

United States

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401

United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

United States

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, 62864

United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

United States

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

United States

Illinois CancerCare-Peru

Peru, Illinois, 61354

United States

Valley Radiation Oncology

Peru, Illinois, 61354

United States

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

United States

Springfield Clinic

Springfield, Illinois, 62702

United States

Memorial Medical Center

Springfield, Illinois, 62781

United States

Southwest Illinois Health Services LLP

Swansea, Illinois, 62226

United States

Carle Cancer Center

Urbana, Illinois, 61801

United States

The Carle Foundation Hospital

Urbana, Illinois, 61801

United States

Illinois CancerCare - Washington

Washington, Illinois, 61571

United States

Rush-Copley Healthcare Center

Yorkville, Illinois, 60560

United States

Reid Health

Richmond, Indiana, 47374

United States

Mary Greeley Medical Center

Ames, Iowa, 50010

United States

McFarland Clinic - Ames

Ames, Iowa, 50010

United States

McFarland Clinic - Boone

Boone, Iowa, 50036

United States

Saint Anthony Regional Hospital

Carroll, Iowa, 51401

United States

Iowa Methodist Medical Center

Des Moines, Iowa, 50309

United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, 50309

United States

Broadlawns Medical Center

Des Moines, Iowa, 50314

United States

Iowa Lutheran Hospital

Des Moines, Iowa, 50316

United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, 50501

United States

Trinity Regional Medical Center

Fort Dodge, Iowa, 50501

United States

McFarland Clinic - Jefferson

Jefferson, Iowa, 50129

United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, 50158

United States

Methodist West Hospital

West Des Moines, Iowa, 50266-7700

United States

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846

United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530

United States

Mercy Health - Paducah Medical Oncology and Hematology

Paducah, Kentucky, 42003

United States

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109

United States

Bronson Battle Creek

Battle Creek, Michigan, 49017

United States

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, 48116

United States

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, 49503

United States

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, 49503

United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, 49503

United States

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007

United States

West Michigan Cancer Center

Kalamazoo, Michigan, 49007

United States

Ascension Borgess Cancer Center

Kalamazoo, Michigan, 49009

United States

Borgess Medical Center

Kalamazoo, Michigan, 49048

United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, 49444

United States

Lakeland Hospital Niles

Niles, Michigan, 49120

United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, 49444

United States

Spectrum Health Reed City Hospital

Reed City, Michigan, 49677

United States

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, 49085

United States

Marie Yeager Cancer Center

Saint Joseph, Michigan, 49085

United States

Munson Medical Center

Traverse City, Michigan, 49684

United States

University of Michigan Health - West

Wyoming, Michigan, 49519

United States

Fairview Ridges Hospital

Burnsville, Minnesota, 55337

United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, 55337

United States

Cambridge Medical Center

Cambridge, Minnesota, 55008

United States

Mercy Hospital

Coon Rapids, Minnesota, 55433

United States

Fairview Southdale Hospital

Edina, Minnesota, 55435

United States

Unity Hospital

Fridley, Minnesota, 55432

United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, 55369

United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, 55109

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, 55407

United States

Hennepin County Medical Center

Minneapolis, Minnesota, 55415

United States

Health Partners Inc

Minneapolis, Minnesota, 55454

United States

Monticello Cancer Center

Monticello, Minnesota, 55362

United States

New Ulm Medical Center

New Ulm, Minnesota, 56073

United States

Fairview Northland Medical Center

Princeton, Minnesota, 55371

United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, 55422

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, 55416

United States

Regions Hospital

Saint Paul, Minnesota, 55101

United States

United Hospital

Saint Paul, Minnesota, 55102

United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, 55379

United States

Lakeview Hospital

Stillwater, Minnesota, 55082

United States

Ridgeview Medical Center

Waconia, Minnesota, 55387

United States

Rice Memorial Hospital

Willmar, Minnesota, 56201

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, 55125

United States

Fairview Lakes Medical Center

Wyoming, Minnesota, 55092

United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, 63011

United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613

United States

Cox Cancer Center Branson

Branson, Missouri, 65616

United States

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

United States

Southeast Cancer Center

Cape Girardeau, Missouri, 63703

United States

Parkland Health Center - Farmington

Farmington, Missouri, 63640

United States

Capital Region Southwest Campus

Jefferson City, Missouri, 65109

United States

Freeman Health System

Joplin, Missouri, 64804

United States

Mercy Hospital Joplin

Joplin, Missouri, 64804

United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, 65401

United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

United States

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506

United States

Saint Louis Cancer and Breast Institute-South City

Saint Louis, Missouri, 63109

United States

Mercy Hospital South

Saint Louis, Missouri, 63128

United States

Missouri Baptist Medical Center

Saint Louis, Missouri, 63131

United States

Mercy Hospital Saint Louis

Saint Louis, Missouri, 63141

United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

United States

Mercy Hospital Springfield

Springfield, Missouri, 65804

United States

CoxHealth South Hospital

Springfield, Missouri, 65807

United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

United States

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, 63127

United States

Mercy Hospital Washington

Washington, Missouri, 63090

United States

Community Hospital of Anaconda

Anaconda, Montana, 59711

United States

Billings Clinic Cancer Center

Billings, Montana, 59101

United States

Bozeman Deaconess Hospital

Bozeman, Montana, 59715

United States

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, 59405

United States

Great Falls Clinic

Great Falls, Montana, 59405

United States

Kalispell Regional Medical Center

Kalispell, Montana, 59901

United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802

United States

Community Medical Hospital

Missoula, Montana, 59804

United States

Cancer Partners of Nebraska - Pine Lake

Lincoln, Nebraska, 68516

United States

Southeast Nebraska Cancer Center - 68th Street Place

Lincoln, Nebraska, 68516

United States

Roswell Park Cancer Institute

Buffalo, New York, 14263

United States

Wake Forest University at Clemmons

Clemmons, North Carolina, 27012

United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, 28328

United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, 27534

United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, 28546

United States

Wake Forest Baptist Health - Hematology Oncology - Statesville

Statesville, North Carolina, 28677

United States

Wake Forest Baptist Health - Wilkes Medical Center

Wilkesboro, North Carolina, 28659

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

United States

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, 44122

United States

Indu and Raj Soin Medical Center

Beavercreek, Ohio, 45431

United States

Strecker Cancer Center-Belpre

Belpre, Ohio, 45714

United States

Saint Elizabeth Boardman Hospital

Boardman, Ohio, 44512

United States

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, 45459

United States

Miami Valley Hospital South

Centerville, Ohio, 45459

United States

Geauga Hospital

Chardon, Ohio, 44024

United States

Adena Regional Medical Center

Chillicothe, Ohio, 45601

United States

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219

United States

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, 45236

United States

Case Western Reserve University

Cleveland, Ohio, 44106

United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Mount Carmel East Hospital

Columbus, Ohio, 43213

United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, 43214

United States

Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

Grant Medical Center

Columbus, Ohio, 43215

United States

The Mark H Zangmeister Center

Columbus, Ohio, 43219

United States

Mount Carmel Health Center West

Columbus, Ohio, 43222

United States

Doctors Hospital

Columbus, Ohio, 43228

United States

Miami Valley Hospital

Dayton, Ohio, 45409

United States

Dayton Physician LLC-Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Miami Valley Hospital North

Dayton, Ohio, 45415

United States

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, 43015

United States

Grady Memorial Hospital

Delaware, Ohio, 43015

United States

Columbus Oncology and Hematology Associates

Dublin, Ohio, 43016

United States

Dublin Methodist Hospital

Dublin, Ohio, 43016

United States

Armes Family Cancer Center

Findlay, Ohio, 45840

United States

Blanchard Valley Hospital

Findlay, Ohio, 45840

United States

Orion Cancer Care

Findlay, Ohio, 45840

United States

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, 45005-1066

United States

Dayton Physicians LLC-Atrium

Franklin, Ohio, 45005

United States

Central Ohio Breast and Endocrine Surgery

Gahanna, Ohio, 43230

United States

Dayton Physicians LLC-Wayne

Greenville, Ohio, 45331

United States

Wayne Hospital

Greenville, Ohio, 45331

United States

Mount Carmel Grove City Hospital

Grove City, Ohio, 43123

United States

Zangmeister Center Grove City

Grove City, Ohio, 43123

United States

Greater Dayton Cancer Center

Kettering, Ohio, 45409

United States

Kettering Medical Center

Kettering, Ohio, 45429

United States

Fairfield Medical Center

Lancaster, Ohio, 43130

United States

Saint Rita's Medical Center

Lima, Ohio, 45801

United States

OhioHealth Mansfield Hospital

Mansfield, Ohio, 44903

United States

Marietta Memorial Hospital

Marietta, Ohio, 45750

United States

OhioHealth Marion General Hospital

Marion, Ohio, 43302

United States

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, 44130

United States

Knox Community Hospital

Mount Vernon, Ohio, 43050

United States

Mount Carmel New Albany Surgical Hospital

New Albany, Ohio, 43054

United States

Licking Memorial Hospital

Newark, Ohio, 43055

United States

Newark Radiation Oncology

Newark, Ohio, 43055

United States

University Hospitals Parma Medical Center

Parma, Ohio, 44129

United States

Mercy Health Perrysburg Cancer Center

Perrysburg, Ohio, 43551

United States

Southern Ohio Medical Center

Portsmouth, Ohio, 45662

United States

University Hospitals Portage Medical Center

Ravenna, Ohio, 44266

United States

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, 44870

United States

Springfield Regional Cancer Center

Springfield, Ohio, 45504

United States

Springfield Regional Medical Center

Springfield, Ohio, 45505

United States

Saint Vincent Mercy Medical Center

Toledo, Ohio, 43608

United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio, 43623

United States

Dayton Physicians LLC - Troy

Troy, Ohio, 45373

United States

Upper Valley Medical Center

Troy, Ohio, 45373

United States

University Hospitals Sharon Health Center

Wadsworth, Ohio, 44281

United States

Saint Joseph Warren Hospital

Warren, Ohio, 44484

United States

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069

United States

Saint Ann's Hospital

Westerville, Ohio, 43081

United States

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, 44145

United States

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, 44501

United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, 43701

United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

United States

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120

United States

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, 97814

United States

Saint Charles Health System

Bend, Oregon, 97701

United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015

United States

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015

United States

Bay Area Hospital

Coos Bay, Oregon, 97420

United States

Providence Newberg Medical Center

Newberg, Oregon, 97132

United States

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, 97914

United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

United States

Providence Portland Medical Center

Portland, Oregon, 97213

United States

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

United States

Saint Charles Health System-Redmond

Redmond, Oregon, 97756

United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, 15232

United States

Avera Cancer Institute

Sioux Falls, South Dakota, 57105

United States

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, 84112

United States

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 98520

United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225

United States

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531

United States

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

United States

Providence Regional Cancer Partnership

Everett, Washington, 98201

United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336

United States

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503

United States

PeaceHealth Saint John Medical Center

Longview, Washington, 98632

United States

Jefferson Healthcare

Port Townsend, Washington, 98368

United States

Pacific Gynecology Specialists

Seattle, Washington, 98104

United States

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107

United States

Swedish Medical Center-Cherry Hill

Seattle, Washington, 98122-5711

United States

Swedish Medical Center-First Hill

Seattle, Washington, 98122

United States

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284

United States

Providence Regional Cancer System-Shelton

Shelton, Washington, 98584

United States

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664

United States

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362

United States

Providence Regional Cancer System-Yelm

Yelm, Washington, 98597

United States

Langlade Hospital and Cancer Center

Antigo, Wisconsin, 54409

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

United States

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, 54601

United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

United States

Aspirus Medford Hospital

Medford, Wisconsin, 54451

United States

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, 54548

United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, 54017

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

United States

Ascension Saint Michael's Hospital

Stevens Point, Wisconsin, 54481

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

United States

Aspirus Regional Cancer Center

Wausau, Wisconsin, 54401

United States

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

United States

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, 54494

United States

Cheyenne Regional Medical Center-West

Cheyenne, Wyoming, 82001

United States

Billings Clinic-Cody

Cody, Wyoming, 82414

United States

Welch Cancer Center

Sheridan, Wyoming, 82801

United States

Collaborators and Investigators

Sponsor: SWOG Cancer Research Network

Zeynep Eroglu, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-01-06

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-01-06

Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

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