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

NCT ID: NCT04511013

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-06

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Binimetinib

Intervention Type DRUG

Given PO

Encorafenib

Intervention Type DRUG

Given PO

Nivolumab

Intervention Type BIOLOGICAL

Given IV

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.

Group Type EXPERIMENTAL

Ipilimumab

Intervention Type BIOLOGICAL

Given IV

Nivolumab

Intervention Type BIOLOGICAL

Given IV

Interventions

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Binimetinib

Given PO

Intervention Type DRUG

Encorafenib

Given PO

Intervention Type DRUG

Ipilimumab

Given IV

Intervention Type BIOLOGICAL

Nivolumab

Given IV

Intervention Type BIOLOGICAL

Other Intervention Names

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ARRY-162 ARRY-438162 MEK162 Mektovi Braftovi LGX 818 LGX-818 LGX818 Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody BMS-734016 MDX-010 MDX-CTLA4 Yervoy BMS-936558 MDX-1106 NIVO ONO-4538 Opdivo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zeynep Eroglu

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

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University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Site Status RECRUITING

Thomas Hospital

Fairhope, Alabama, United States

Site Status RECRUITING

Mobile Infirmary Medical Center

Mobile, Alabama, United States

Site Status RECRUITING

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, United States

Site Status RECRUITING

Anchorage Radiation Therapy Center

Anchorage, Alaska, United States

Site Status RECRUITING

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status RECRUITING

Alaska Oncology and Hematology LLC

Anchorage, Alaska, United States

Site Status RECRUITING

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status RECRUITING

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status RECRUITING

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status RECRUITING

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status RECRUITING

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status RECRUITING

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status RECRUITING

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status RECRUITING

Epic Care-Dublin

Dublin, California, United States

Site Status RECRUITING

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status RECRUITING

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status RECRUITING

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status RECRUITING

Providence Queen of The Valley

Napa, California, United States

Site Status RECRUITING

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status SUSPENDED

Bay Area Tumor Institute

Oakland, California, United States

Site Status RECRUITING

Sharp Memorial Hospital

San Diego, California, United States

Site Status RECRUITING

Providence Medical Foundation - Santa Rosa

Santa Rosa, California, United States

Site Status RECRUITING

Providence Santa Rosa Memorial Hospital

Santa Rosa, California, United States

Site Status RECRUITING

Epic Care Cyberknife Center

Walnut Creek, California, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status RECRUITING

The Medical Center of Aurora

Aurora, Colorado, United States

Site Status SUSPENDED

University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Site Status RECRUITING

The Women's Imaging Center

Denver, Colorado, United States

Site Status RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status RECRUITING

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status RECRUITING

Rose Medical Center

Denver, Colorado, United States

Site Status SUSPENDED

Western Surgical Care

Denver, Colorado, United States

Site Status SUSPENDED

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Site Status RECRUITING

Swedish Medical Center

Englewood, Colorado, United States

Site Status RECRUITING

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

Site Status RECRUITING

North Colorado Medical Center

Greeley, Colorado, United States

Site Status SUSPENDED

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status RECRUITING

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status SUSPENDED

McKee Medical Center

Loveland, Colorado, United States

Site Status SUSPENDED

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

UM Sylvester Comprehensive Cancer Center at Kendall

Miami, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, United States

Site Status RECRUITING

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Moffitt Cancer Center-International Plaza

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center - McKinley Campus

Tampa, Florida, United States

Site Status RECRUITING

Moffitt Cancer Center

Tampa, Florida, United States

Site Status RECRUITING

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

Savannah, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Site Status RECRUITING

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Site Status RECRUITING

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, United States

Site Status RECRUITING

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Site Status RECRUITING

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Site Status RECRUITING

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Site Status RECRUITING

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, United States

Site Status RECRUITING

Saint Anthony's Health

Alton, Illinois, United States

Site Status RECRUITING

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status RECRUITING

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Site Status RECRUITING

SIH Cancer Institute

Carterville, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status RECRUITING

Saint Mary's Hospital

Centralia, Illinois, United States

Site Status RECRUITING

Northwestern University

Chicago, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status RECRUITING

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status RECRUITING

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Site Status ACTIVE_NOT_RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status RECRUITING

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Valley Radiation Oncology

Peru, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Memorial Medical Center

Springfield, Illinois, United States

Site Status RECRUITING

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Site Status SUSPENDED

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status RECRUITING

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Site Status RECRUITING

Reid Health

Richmond, Indiana, United States

Site Status RECRUITING

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Boone

Boone, Iowa, United States

Site Status RECRUITING

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Site Status RECRUITING

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa, United States

Site Status RECRUITING

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

Site Status RECRUITING

Trinity Regional Medical Center

Fort Dodge, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Site Status RECRUITING

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status RECRUITING

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Site Status RECRUITING

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Site Status RECRUITING

Mercy Health - Paducah Medical Oncology and Hematology

Paducah, Kentucky, United States

Site Status RECRUITING

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Site Status RECRUITING

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status RECRUITING

University of Michigan - Brighton Center for Specialty Care

Brighton, Michigan, United States

Site Status RECRUITING

Helen DeVos Children's Hospital at Spectrum Health

Grand Rapids, Michigan, United States

Site Status RECRUITING

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Site Status RECRUITING

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Site Status RECRUITING

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

Site Status RECRUITING

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

Ascension Borgess Cancer Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

Borgess Medical Center

Kalamazoo, Michigan, United States

Site Status RECRUITING

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Site Status RECRUITING

Lakeland Hospital Niles

Niles, Michigan, United States

Site Status RECRUITING

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Site Status RECRUITING

Spectrum Health Reed City Hospital

Reed City, Michigan, United States

Site Status RECRUITING

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, United States

Site Status RECRUITING

Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status RECRUITING

Munson Medical Center

Traverse City, Michigan, United States

Site Status RECRUITING

University of Michigan Health - West

Wyoming, Michigan, United States

Site Status RECRUITING

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status SUSPENDED

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status RECRUITING

Cambridge Medical Center

Cambridge, Minnesota, United States

Site Status RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status RECRUITING

Unity Hospital

Fridley, Minnesota, United States

Site Status RECRUITING

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status RECRUITING

Monticello Cancer Center

Monticello, Minnesota, United States

Site Status RECRUITING

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status RECRUITING

Fairview Northland Medical Center

Princeton, Minnesota, United States

Site Status RECRUITING

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

United Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status RECRUITING

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status RECRUITING

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status RECRUITING

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status RECRUITING

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Site Status RECRUITING

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Site Status RECRUITING

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Site Status RECRUITING

Cox Cancer Center Branson

Branson, Missouri, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status RECRUITING

Capital Region Southwest Campus

Jefferson City, Missouri, United States

Site Status RECRUITING

Freeman Health System

Joplin, Missouri, United States

Site Status RECRUITING

Mercy Hospital Joplin

Joplin, Missouri, United States

Site Status RECRUITING

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Site Status RECRUITING

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status RECRUITING

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status RECRUITING

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status RECRUITING

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status RECRUITING

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital South

St Louis, Missouri, United States

Site Status RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status RECRUITING

Missouri Baptist Outpatient Center-Sunset Hills

Sunset Hills, Missouri, United States

Site Status RECRUITING

Mercy Hospital Washington

Washington, Missouri, United States

Site Status RECRUITING

Community Hospital of Anaconda

Anaconda, Montana, United States

Site Status RECRUITING

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status RECRUITING

Bozeman Deaconess Hospital

Bozeman, Montana, United States

Site Status RECRUITING

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status RECRUITING

Great Falls Clinic

Great Falls, Montana, United States

Site Status RECRUITING

Kalispell Regional Medical Center

Kalispell, Montana, United States

Site Status RECRUITING

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status RECRUITING

Community Medical Hospital

Missoula, Montana, United States

Site Status RECRUITING

Cancer Partners of Nebraska - Pine Lake

Lincoln, Nebraska, United States

Site Status RECRUITING

Southeast Nebraska Cancer Center - 68th Street Place

Lincoln, Nebraska, United States

Site Status RECRUITING

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status ACTIVE_NOT_RECRUITING

Wake Forest University at Clemmons

Clemmons, North Carolina, United States

Site Status RECRUITING

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Site Status RECRUITING

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status RECRUITING

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Site Status RECRUITING

Wake Forest Baptist Health - Hematology Oncology - Statesville

Statesville, North Carolina, United States

Site Status RECRUITING

Wake Forest Baptist Health - Wilkes Medical Center

Wilkesboro, North Carolina, United States

Site Status RECRUITING

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status RECRUITING

UHHS-Chagrin Highlands Medical Center

Beachwood, Ohio, United States

Site Status RECRUITING

Indu and Raj Soin Medical Center

Beavercreek, Ohio, United States

Site Status RECRUITING

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Site Status RECRUITING

Saint Elizabeth Boardman Hospital

Boardman, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status SUSPENDED

Geauga Hospital

Chardon, Ohio, United States

Site Status RECRUITING

Adena Regional Medical Center

Chillicothe, Ohio, United States

Site Status RECRUITING

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, United States

Site Status RECRUITING

Case Western Reserve University

Cleveland, Ohio, United States

Site Status RECRUITING

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status RECRUITING

Mount Carmel East Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Site Status RECRUITING

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Grant Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

The Mark H Zangmeister Center

Columbus, Ohio, United States

Site Status RECRUITING

Mount Carmel Health Center West

Columbus, Ohio, United States

Site Status RECRUITING

Doctors Hospital

Columbus, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital

Dayton, Ohio, United States

Site Status SUSPENDED

Dayton Physician LLC-Miami Valley Hospital North

Dayton, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status SUSPENDED

Delaware Health Center-Grady Cancer Center

Delaware, Ohio, United States

Site Status RECRUITING

Grady Memorial Hospital

Delaware, Ohio, United States

Site Status RECRUITING

Columbus Oncology and Hematology Associates

Dublin, Ohio, United States

Site Status RECRUITING

Dublin Methodist Hospital

Dublin, Ohio, United States

Site Status RECRUITING

Armes Family Cancer Center

Findlay, Ohio, United States

Site Status RECRUITING

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status RECRUITING

Orion Cancer Care

Findlay, Ohio, United States

Site Status RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status SUSPENDED

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Site Status RECRUITING

Central Ohio Breast and Endocrine Surgery

Gahanna, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC-Wayne

Greenville, Ohio, United States

Site Status RECRUITING

Wayne Hospital

Greenville, Ohio, United States

Site Status RECRUITING

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Site Status RECRUITING

Zangmeister Center Grove City

Grove City, Ohio, United States

Site Status RECRUITING

Greater Dayton Cancer Center

Kettering, Ohio, United States

Site Status RECRUITING

Kettering Medical Center

Kettering, Ohio, United States

Site Status RECRUITING

Fairfield Medical Center

Lancaster, Ohio, United States

Site Status RECRUITING

Saint Rita's Medical Center

Lima, Ohio, United States

Site Status RECRUITING

OhioHealth Mansfield Hospital

Mansfield, Ohio, United States

Site Status RECRUITING

Marietta Memorial Hospital

Marietta, Ohio, United States

Site Status RECRUITING

OhioHealth Marion General Hospital

Marion, Ohio, United States

Site Status RECRUITING

UH Seidman Cancer Center at Southwest General Hospital

Middleburg Heights, Ohio, United States

Site Status RECRUITING

Knox Community Hospital

Mount Vernon, Ohio, United States

Site Status RECRUITING

Mount Carmel New Albany Surgical Hospital

New Albany, Ohio, United States

Site Status RECRUITING

Licking Memorial Hospital

Newark, Ohio, United States

Site Status RECRUITING

Newark Radiation Oncology

Newark, Ohio, United States

Site Status RECRUITING

University Hospitals Parma Medical Center

Parma, Ohio, United States

Site Status RECRUITING

Mercy Health Perrysburg Cancer Center

Perrysburg, Ohio, United States

Site Status RECRUITING

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Site Status RECRUITING

University Hospitals Portage Medical Center

Ravenna, Ohio, United States

Site Status RECRUITING

UH Seidman Cancer Center at Firelands Regional Medical Center

Sandusky, Ohio, United States

Site Status RECRUITING

Springfield Regional Cancer Center

Springfield, Ohio, United States

Site Status RECRUITING

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status RECRUITING

Saint Vincent Mercy Medical Center

Toledo, Ohio, United States

Site Status RECRUITING

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC - Troy

Troy, Ohio, United States

Site Status RECRUITING

Upper Valley Medical Center

Troy, Ohio, United States

Site Status SUSPENDED

University Hospitals Sharon Health Center

Wadsworth, Ohio, United States

Site Status RECRUITING

Saint Joseph Warren Hospital

Warren, Ohio, United States

Site Status RECRUITING

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Ann's Hospital

Westerville, Ohio, United States

Site Status RECRUITING

UH Seidman Cancer Center at Saint John Medical Center

Westlake, Ohio, United States

Site Status RECRUITING

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

Site Status RECRUITING

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Saint Alphonsus Medical Center-Baker City

Baker City, Oregon, United States

Site Status RECRUITING

Saint Charles Health System

Bend, Oregon, United States

Site Status RECRUITING

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status RECRUITING

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, United States

Site Status RECRUITING

Bay Area Hospital

Coos Bay, Oregon, United States

Site Status RECRUITING

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status RECRUITING

Saint Alphonsus Medical Center-Ontario

Ontario, Oregon, United States

Site Status RECRUITING

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Site Status RECRUITING

Providence Portland Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Saint Charles Health System-Redmond

Redmond, Oregon, United States

Site Status RECRUITING

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status ACTIVE_NOT_RECRUITING

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status RECRUITING

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, United States

Site Status RECRUITING

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status RECRUITING

Providence Regional Cancer System-Centralia

Centralia, Washington, United States

Site Status RECRUITING

Swedish Cancer Institute-Edmonds

Edmonds, Washington, United States

Site Status RECRUITING

Providence Regional Cancer Partnership

Everett, Washington, United States

Site Status RECRUITING

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

Site Status RECRUITING

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Site Status RECRUITING

Providence Regional Cancer System-Lacey

Lacey, Washington, United States

Site Status RECRUITING

PeaceHealth Saint John Medical Center

Longview, Washington, United States

Site Status RECRUITING

Jefferson Healthcare

Port Townsend, Washington, United States

Site Status RECRUITING

Pacific Gynecology Specialists

Seattle, Washington, United States

Site Status SUSPENDED

Swedish Medical Center-Ballard Campus

Seattle, Washington, United States

Site Status RECRUITING

Swedish Medical Center-Cherry Hill

Seattle, Washington, United States

Site Status RECRUITING

Swedish Medical Center-First Hill

Seattle, Washington, United States

Site Status RECRUITING

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, United States

Site Status RECRUITING

Providence Regional Cancer System-Shelton

Shelton, Washington, United States

Site Status RECRUITING

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status RECRUITING

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, United States

Site Status RECRUITING

Providence Regional Cancer System-Yelm

Yelm, Washington, United States

Site Status RECRUITING

Langlade Hospital and Cancer Center

Antigo, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Site Status RECRUITING

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status RECRUITING

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status RECRUITING

Aspirus Medford Hospital

Medford, Wisconsin, United States

Site Status RECRUITING

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

Site Status RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status RECRUITING

Ascension Saint Michael's Hospital

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Site Status RECRUITING

Aspirus Regional Cancer Center

Wausau, Wisconsin, United States

Site Status RECRUITING

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Site Status RECRUITING

Aspirus Cancer Care - Wisconsin Rapids

Wisconsin Rapids, Wisconsin, United States

Site Status RECRUITING

Cheyenne Regional Medical Center-West

Cheyenne, Wyoming, United States

Site Status RECRUITING

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status RECRUITING

Welch Cancer Center

Sheridan, Wyoming, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Catrina Mireles

Role: CONTACT

2106148808 ext. 1014

Dana Sparks

Role: CONTACT

12106148808 ext. 1004

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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614-488-2118

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614-488-2118

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937-528-2900

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800-641-2422

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614-234-5433

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800-641-2422

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740-454-5232

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405-271-8777

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503-215-2614

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406-969-6060

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503-215-2614

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503-215-2614

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503-215-2614

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541-706-2909

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412-647-8073

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888-424-2100

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360-412-8958

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360-788-8223

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360-412-8958

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425-261-3529

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509-783-4637

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360-412-8958

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360-514-2016

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360-344-3091

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206-215-3086

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206-215-3086

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206-215-3086

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360-788-8238

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360-514-3940

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509-897-5993

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360-412-8958

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715-623-9869

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800-782-8581

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608-775-2385

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800-622-8922

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800-782-8581

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2020-05496

Identifier Type: REGISTRY

Identifier Source: secondary_id

S2000

Identifier Type: OTHER

Identifier Source: secondary_id

S2000

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180888

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S2000

Identifier Type: -

Identifier Source: org_study_id

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