Recruiting
Phase 2

Neratinib & Palbociclib

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06126276

Conditions

Malignant Female Reproductive System Neoplasm

Malignant Solid Neoplasm

Recurrent Malignant Female Reproductive System Neoplasm

Recurrent Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biopsy Procedure

Biospecimen Collection

Computed Tomography

Echocardiography Test

Magnetic Resonance Imaging

Study Details

Brief summary:

This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.

Conditions

Malignant Female Reproductive System Neoplasm

Malignant Solid Neoplasm

Recurrent Malignant Female Reproductive System Neoplasm

Recurrent Malignant Solid Neoplasm

Study ID

NCT06126276

Start date

May 7, 2024

Status verified date

Mar, 2026

Completion date

Feb 20, 2027

Anticipated

Primary completion date

Feb 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-N5 based on the presence of an actionable mutation as defined in EAY191
  • Patients must have a HER2 amplified solid tumor except breast cancer.

  • If IHC is 0 or 1+, patient (pt) is NOT ELIGIBLE regardless of in situ hybridization (ISH)/FISH or next generation sequencing (NGS) status
  • If IHC is 3+, pt IS ELIGIBLE regardless of ISH/FISH or NGS status
  • If IHC is 2+, ISH/FISH OR NGS must be positive for the patient to be ELIGIBLE. Otherwise, pt is NOT ELIGIBLE
  • If IHC is unknown and…

  • ISH/FISH is positive, independent of NGS results, the patient IS ELIGIBLE
  • ISH/FISH is negative and NGS positive with ≥ 7 copies, the patient IS ELIGIBLE
  • Patients must have recurrent or persistent disease
  • No known evidence of RB1 loss or deletion including copy number loss or deleterious mutation
  • Patients must have disease that can be safely biopsied and agree to a pre-treatment biopsy or, if disease cannot be safely biopsied, have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191)
  • Patients must have measurable disease based on RECIST 1.1. A second measurable lesion outside of the biopsiable lesion is required
  • Patients with treated brain metastases are eligible if follow up brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression for 3 months or more and patient is not on steroids and is asymptomatic
  • No known leptomeningeal disease
  • Patients may have received up to 5 prior lines of systemic therapy
  • Prior therapy with trastuzumab or pertuzumab, either alone or in combination, antibody drug conjugates (ADC) such as DS8201a or T-DM1 is allowed
  • No prior therapy with HER2 targeting tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib
  • No prior therapy with CDK4/6 inhibition
  • No cancer directed therapy within 3 weeks prior to registration. For oral therapy, the washout can be reduced to greater than or equal to 5 half lives of the drug. No HER2 targeting ADCs within 30 days prior to registration
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
  • Not pregnant and not nursing
  • Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
  • Platelets ≥ 100,000 cells/mm\^3
  • Hemoglobin ≥ 9 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin (Hgb) ≥ 9 g/dl is acceptable)
  • Creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula
  • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional upper limit of normal (ULN)
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • No active infection requiring parenteral antibiotics
  • No current evidence of intra-abdominal abscess, abdominal/pelvic fistula (not diverted), gastrointestinal perforation, gastrointestinal (GI) obstruction, and/or need for drainage nasogastric or gastrostomy tube
  • No current evidence of malabsorption or chronic diarrhea or any other significant gastro-intestinal disease (e.g gastrectomy, ileal bypass, Crohn's disease, gastroparesis), associated with moderate to severe diarrhea (grade 2 or more) or inability to tolerate oral therapy
  • No lung disease causing dyspnea at rest
  • No interstitial lung disease with ongoing signs and symptoms at the time of registration
  • No history of allergic reaction to the study agents, compound of similar chemical or biologic composition of the study agents or any of their excipients

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm I (neratinib maleate)

Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients who experience progression may crossover to Arm II. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

experimental: Arm II (neratinib maleate, palbociclib)

Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.

Interventions

Biopsy Procedure

Undergo tumor biopsy

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo CT scan

Echocardiography Test

Undergo ECHO

Magnetic Resonance Imaging

Undergo MRI

Multigated Acquisition Scan

Undergo MUGA

Neratinib Maleate

Given PO

Palbociclib

Given PO

Primary outcome measure

  • Progression free survival [ Time Frame: From study entry to time of progression or death, whichever occurs first, or date of last contact if neither progression nor death has occurred, assessed up to 2 years ]

Central Contacts and Locations

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

gingerreeves@uabmc.edu

Principal Investigator:

Rebecca C. Arend

University of South Alabama Mitchell Cancer Institute

Recruiting

Mobile, Alabama, United States, 36688

Contacts

Site Public Contact

251-445-9870pfrancisco@usouthal.edu

Principal Investigator:

Ahmed Abdalla

Alaska Women's Cancer Care

Recruiting

Anchorage, Alaska, United States, 99508

Contacts

Site Public Contact

907-212-6871AKPAMC.OncologyResearchSupport@providence.org

Principal Investigator:

Dan S. Zuckerman

UC San Diego Health System - Encinitas

Recruiting

Encinitas, California, United States, 92024

Contacts

Site Public Contact

760-536-7700

Principal Investigator:

Peter Vu

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Site Public Contact

858-822-5354cancercto@ucsd.edu

Principal Investigator:

Peter Vu

The Angeles Clinic and Research Institute - West Los Angeles Office

Recruiting

Los Angeles, California, United States, 90025

Contacts

Site Public Contact

888-823-5923ctsucontact@westat.com

Principal Investigator:

Omid Hamid

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Site Public Contact

310-423-2133Cancer.trial.info@cshs.org

Principal Investigator:

Omid Hamid

UC San Diego Medical Center - Hillcrest

Recruiting

San Diego, California, United States, 92103

Contacts

Site Public Contact

rhabbaba@health.ucsd.edu

Principal Investigator:

Peter Vu

UM Sylvester Comprehensive Cancer Center at Aventura

Recruiting

Aventura, Florida, United States, 33180

Contacts

Site Public Contact

954-461-2180

Principal Investigator:

Matthew P. Schlumbrecht

UM Sylvester Comprehensive Cancer Center at Coral Gables

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Matthew P. Schlumbrecht

UM Sylvester Comprehensive Cancer Center at Coral Springs

Recruiting

Coral Springs, Florida, United States, 33065

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Matthew P. Schlumbrecht

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Matthew P. Schlumbrecht

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Matthew P. Schlumbrecht

UM Sylvester Comprehensive Cancer Center at Kendall

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Matthew P. Schlumbrecht

University of Miami Sylvester Comprehensive Cancer Center at Sole Mia

Recruiting

North Miami, Florida, United States, 33181

Contacts

Site Public Contact

kginnity@med.miami.edu

Principal Investigator:

Matthew P. Schlumbrecht

UM Sylvester Comprehensive Cancer Center at Plantation

Recruiting

Plantation, Florida, United States, 33324

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Matthew P. Schlumbrecht

Saint Alphonsus Cancer Care Center-Boise

Recruiting

Boise, Idaho, United States, 83706

Contacts

Site Public Contact

734-712-3671stephanie.couch@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Saint Luke's Cancer Institute - Boise

Recruiting

Boise, Idaho, United States, 83712

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Alphonsus Cancer Care Center-Caldwell

Recruiting

Caldwell, Idaho, United States, 83605

Contacts

Site Public Contact

734-712-3671stephanie.couch@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Kootenai Health - Coeur d'Alene

Recruiting

Coeur d'Alene, Idaho, United States, 83814

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Saint Luke's Cancer Institute - Fruitland

Recruiting

Fruitland, Idaho, United States, 83619

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Luke's Cancer Institute - Meridian

Recruiting

Meridian, Idaho, United States, 83642

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Saint Alphonsus Cancer Care Center-Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

Tareq Al baghdadi

Saint Luke's Cancer Institute - Nampa

Recruiting

Nampa, Idaho, United States, 83687

Contacts

Site Public Contact

208-381-2774eslinget@slhs.org

Principal Investigator:

Dan S. Zuckerman

Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, United States, 83854

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, United States, 83864

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

SIH Cancer Institute

Recruiting

Carterville, Illinois, United States, 62918

Contacts

Site Public Contact

618-985-3333clinical.research@sih.net

Principal Investigator:

Bryan A. Faller

University of Illinois

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-355-3046

Principal Investigator:

Ryan Nguyen

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Maria T. Grosse-Perdekamp

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Maria T. Grosse-Perdekamp

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

NorthShore University HealthSystem-Evanston Hospital

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Mary T. Jenkins Vogel

NorthShore University HealthSystem-Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Mary T. Jenkins Vogel

NorthShore University HealthSystem-Highland Park Hospital

Recruiting

Highland Park, Illinois, United States, 60035

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Mary T. Jenkins Vogel

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Maria T. Grosse-Perdekamp

Carle BroMenn Medical Center

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Maria T. Grosse-Perdekamp

Carle Cancer Institute Normal

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Maria T. Grosse-Perdekamp

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Public Contact

217-876-4762morganthaler.jodi@mhsil.com

Principal Investigator:

Bryan A. Faller

Mercyhealth Cancer Institute - Rockford

Recruiting

Rockford, Illinois, United States, 61114

Contacts

Site Public Contact

815-971-5858oncologyclinicaltrials@mhemail.org

Principal Investigator:

Mayur Narkhede

Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

217-545-7929

Principal Investigator:

Bryan A. Faller

Springfield Clinic

Recruiting

Springfield, Illinois, United States, 62702

Contacts

Site Public Contact

800-444-7541

Principal Investigator:

Bryan A. Faller

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, United States, 62781

Contacts

Site Public Contact

217-528-7541pallante.beth@mhsil.com

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Maria T. Grosse-Perdekamp

Woodland Cancer Care Center

Recruiting

Michigan City, Indiana, United States, 46360

Contacts

Site Public Contact

219-861-5800Anna.Huron@franciscanalliance.org

Principal Investigator:

William H. Bae

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Recruiting

Ankeny, Iowa, United States, 50023

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

UI Health Care Mission Cancer and Blood - Waukee Clinic

Recruiting

Waukee, Iowa, United States, 50263

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

CommonSpirit Saint Joseph Medical Center - East Lexington

Recruiting

Lexington, Kentucky, United States, 40509

Contacts

Site Public Contact

720-874-1881ResearchInstituteInquiries@CommonSpirit.org

Principal Investigator:

Shahzad Siddique

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Susanne M. Arnold

Harold Alfond Center for Cancer Care

Recruiting

Augusta, Maine, United States, 04330

Contacts

Site Public Contact

207-626-4855

Principal Investigator:

Leslie S. Bradford

Lafayette Family Cancer Center-EMMC

Recruiting

Brewer, Maine, United States, 04412

Contacts

Site Public Contact

800-987-3005

Principal Investigator:

Sarah J. Sinclair

MaineHealth Maine Medical Center- Scarborough

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Site Public Contact

207-396-8670clinicalresearch@mainehealth.org

Principal Investigator:

Leslie S. Bradford

University of Maryland/Greenebaum Cancer Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Site Public Contact

800-888-8823

Principal Investigator:

Ranee Mehra

Walter Reed National Military Medical Center

Recruiting

Bethesda, Maryland, United States, 20889-5600

Contacts

Site Public Contact

301-319-2100

Principal Investigator:

Christopher Tarney

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Site Public Contact

800-411-1222

Principal Investigator:

Sarah Shin

UPMC Western Maryland

Recruiting

Cumberland, Maryland, United States, 21502

Contacts

Site Public Contact

240-964-1400

Principal Investigator:

Sarah E. Taylor

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

OSF Saint Francis Hospital and Medical Group

Recruiting

Escanaba, Michigan, United States, 49829

Contacts

Site Public Contact

920-433-8889WI_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Cancer Hematology Centers - Flint

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Tareq Al baghdadi

Genesys Hurley Cancer Institute

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Tareq Al baghdadi

Hurley Medical Center

Recruiting

Flint, Michigan, United States, 48503

Contacts

Site Public Contact

810-762-8038wstrong@ghci.org

Principal Investigator:

Tareq Al baghdadi

University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Site Public Contact

517-364-3712harsha.trivedi@umhsparrow.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Recruiting

Ypsilanti, Michigan, United States, 48197

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Tareq Al baghdadi

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Site Public Contact

218-333-5000OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Essentia Health - Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Minnesota Oncology - Edina

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Site Public Contact

218-786-3308

Principal Investigator:

Bret E. Friday

Saint John's Hospital - Healtheast

Recruiting

Maplewood, Minnesota, United States, 55109

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Community Hospital of Anaconda

Recruiting

Anaconda, Montana, United States, 59711

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Bozeman Health Deaconess Hospital

Recruiting

Bozeman, Montana, United States, 59715

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Logan Health Medical Center

Recruiting

Kalispell, Montana, United States, 59901

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

Community Medical Center

Recruiting

Missoula, Montana, United States, 59804

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

John M. Schallenkamp

OptumCare Cancer Care at Charleston

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

John A. Ellerton

OptumCare Cancer Care at Fort Apache

Recruiting

Las Vegas, Nevada, United States, 89183

Contacts

Site Public Contact

702-384-0013research@sncrf.org

Principal Investigator:

John A. Ellerton

Jersey City Medical Center

Recruiting

Jersey City, New Jersey, United States, 07302

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Eugenia Girda

Monmouth Medical Center Southern Campus

Recruiting

Lakewood, New Jersey, United States, 08701

Contacts

Site Public Contact

732-923-6564mary.danish@rwjbh.org

Principal Investigator:

Eugenia Girda

Monmouth Medical Center

Recruiting

Long Branch, New Jersey, United States, 07740

Contacts

Site Public Contact

732-923-6564mary.danish@rwjbh.org

Principal Investigator:

Eugenia Girda

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-7356

Principal Investigator:

Eugenia Girda

Community Medical Center

Recruiting

Toms River, New Jersey, United States, 08755

Contacts

Site Public Contact

732-557-8294Lennette.Gonzales@rwjbh.org

Principal Investigator:

Eugenia Girda

University of New Mexico Cancer Center

Recruiting

Albuquerque, New Mexico, United States, 87106

Contacts

Site Public Contact

505-925-0348HSC-ClinicalTrialInfo@salud.unm.edu

Principal Investigator:

Carolyn Y. Muller

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Site Public Contact

800-767-9355askroswell@roswellpark.org

Principal Investigator:

Ellis G. Levine

State University of New York Upstate Medical University

Recruiting

Syracuse, New York, United States, 13210

Contacts

Site Public Contact

315-464-5476

Principal Investigator:

Mary J. Cunningham

Cone Health MedCenter Asheboro

Recruiting

Asheboro, North Carolina, United States, 27205

Contacts

Site Public Contact

336-832-0836stacey.phelps@conehealth.com

Principal Investigator:

Ni Gorsuch

Cone Health Cancer Center at Alamance Regional

Recruiting

Burlington, North Carolina, United States, 27215

Contacts

Site Public Contact

336-832-0836stacey.phelps@conehealth.com

Principal Investigator:

Ni Gorsuch

Southeastern Medical Oncology Center-Clinton

Recruiting

Clinton, North Carolina, United States, 28328

Contacts

Site Public Contact

919-587-9084jfields@cancersmoc.com

Principal Investigator:

Samer S. Kasbari

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Angeles A. Secord

Southeastern Medical Oncology Center-Goldsboro

Recruiting

Goldsboro, North Carolina, United States, 27534

Contacts

Site Public Contact

919-587-9084jfields@cancersmoc.com

Principal Investigator:

Samer S. Kasbari

Cone Health Cancer Center

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Site Public Contact

336-832-0836stacey.phelps@conehealth.com

Principal Investigator:

Ni Gorsuch

Cone Health Cancer Center at Drawbridge Parkway

Recruiting

Greensboro, North Carolina, United States, 27410

Contacts

Site Public Contact

336-832-0836stacey.phelps@conehealth.com

Principal Investigator:

Ni Gorsuch

Southeastern Medical Oncology Center-Jacksonville

Recruiting

Jacksonville, North Carolina, United States, 28546

Contacts

Site Public Contact

910-587-9084jfields@cancersmoc.com

Principal Investigator:

Samer S. Kasbari

Duke Women's Cancer Care Raleigh

Recruiting

Raleigh, North Carolina, United States, 27607

Contacts

Site Public Contact

919-785-4878

Principal Investigator:

Angeles A. Secord

Annie Penn Memorial Hospital

Recruiting

Reidsville, North Carolina, United States, 27320

Contacts

Site Public Contact

336-832-0836stacey.phelps@conehealth.com

Principal Investigator:

Ni Gorsuch

Sanford Bismarck Medical Center

Recruiting

Bismarck, North Dakota, United States, 58501

Contacts

Site Public Contact

701-323-5760OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Site Public Contact

701-323-5760OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Site Public Contact

701-234-6161OncologyClinicalTrialsFargo@sanfordhealth.org

Principal Investigator:

Daniel Almquist

OhioHealth O'Bleness Hospital

Recruiting

Athens, Ohio, United States, 45701

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Miami Valley Hospital South

Recruiting

Centerville, Ohio, United States, 45459

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Floor Backes

Columbus Oncology and Hematology Associates Inc

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Grant Medical Center

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Doctors Hospital

Recruiting

Columbus, Ohio, United States, 43228

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Miami Valley Hospital

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Premier Blood and Cancer Center

Recruiting

Dayton, Ohio, United States, 45409

Contacts

Site Public Contact

937-276-8320

Principal Investigator:

Tarek M. Sabagh

Miami Valley Hospital North

Recruiting

Dayton, Ohio, United States, 45415

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Delaware Health Center-Grady Cancer Center

Recruiting

Delaware, Ohio, United States, 43015

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Grady Memorial Hospital

Recruiting

Delaware, Ohio, United States, 43015

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Columbus Oncology and Hematology Associates

Recruiting

Dublin, Ohio, United States, 43016

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Dublin Methodist Hospital

Recruiting

Dublin, Ohio, United States, 43016

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Atrium Medical Center-Middletown Regional Hospital

Recruiting

Franklin, Ohio, United States, 45005-1066

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

Miami Valley Cancer Care and Infusion

Recruiting

Greenville, Ohio, United States, 45331

Contacts

Site Public Contact

937-569-7515

Principal Investigator:

Tarek M. Sabagh

OhioHealth Mansfield Hospital

Recruiting

Mansfield, Ohio, United States, 44903

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

OhioHealth Marion General Hospital

Recruiting

Marion, Ohio, United States, 43302

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

OhioHealth Pickerington Methodist Hospital

Recruiting

Pickerington, Ohio, United States, 43147

Contacts

Site Public Contact

614-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

Upper Valley Medical Center

Recruiting

Troy, Ohio, United States, 45373

Contacts

Site Public Contact

937-528-2900clinical.trials@daytonncorp.org

Principal Investigator:

Tarek M. Sabagh

OhioHealth Westerville Medical Campus/Westerville Cancer Center

Recruiting

Westerville, Ohio, United States, 43082

Contacts

Site Public Contact

610-788-3860Jennifer.Sexton@ohiohealth.com

Principal Investigator:

Aine E. Clements

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Site Public Contact

405-271-8777ou-clinical-trials@ouhsc.edu

Principal Investigator:

Lauren E. Dockery

Saint Alphonsus Cancer Care Center-Ontario

Recruiting

Ontario, Oregon, United States, 97914

Contacts

Site Public Contact

406-969-6060mccinfo@mtcancer.org

Principal Investigator:

Tareq Al baghdadi

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Dan S. Zuckerman

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Dan S. Zuckerman

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080trials@ohsu.edu

Principal Investigator:

Elizabeth G. Munro

UPMC Altoona

Recruiting

Altoona, Pennsylvania, United States, 16601

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Sarah E. Taylor

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Sarah E. Taylor

UPMC Cancer Centers - Arnold Palmer Pavilion

Recruiting

Greensburg, Pennsylvania, United States, 15601

Contacts

Site Public Contact

724-838-1900

Principal Investigator:

Sarah E. Taylor

UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Recruiting

Mechanicsburg, Pennsylvania, United States, 17050

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Sarah E. Taylor

UPMC Hillman Cancer Center - Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Sarah E. Taylor

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Mitchell I. Edelson

UPMC-Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Site Public Contact

412-647-2811

Principal Investigator:

Sarah E. Taylor

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Sarah E. Taylor

UPMC-Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Site Public Contact

412-367-6454

Principal Investigator:

Sarah E. Taylor

Asplundh Cancer Pavilion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Site Public Contact

215-600-9151ONCTrialNow@jefferson.edu

Principal Investigator:

Mitchell I. Edelson

Women and Infants Hospital

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Site Public Contact

401-274-1122

Principal Investigator:

Paul A. DiSilvestro

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Site Public Contact

605-312-3320OncologyClinicTrialsSF@sanfordhealth.org

Principal Investigator:

Daniel Almquist

Sanford USD Medical Center - Sioux Falls

Recruiting

Sioux Falls, South Dakota, United States, 57117-5134

Contacts

Site Public Contact

605-312-3320OncologyClinicalTrialsSF@SanfordHealth.org

Principal Investigator:

Daniel Almquist

Bristol Regional Medical Center

Recruiting

Bristol, Tennessee, United States, 37620

Contacts

Site Public Contact

423-431-5654charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

Regional Cancer Center at Johnson City Medical Center

Recruiting

Johnson City, Tennessee, United States, 37604

Contacts

Site Public Contact

423-431-5654charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

Ballad Health Cancer Care - Kingsport

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Site Public Contact

423-431-5654charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

Wellmont Holston Valley Hospital and Medical Center

Recruiting

Kingsport, Tennessee, United States, 37660

Contacts

Site Public Contact

423-431-5654charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Jennifer H. Choe

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Site Public Contact

214-590-5582canceranswerline@UTSouthwestern.edu

Principal Investigator:

James L. Wilder

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

James L. Wilder

UT Southwestern/Simmons Cancer Center-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

James L. Wilder

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

866-632-6789askmdanderson@mdanderson.org

Principal Investigator:

Sarina A. Piha-Paul

UT Southwestern Clinical Center at Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Contacts

Site Public Contact

972-669-7044Suzanne.cole@utsouthwestern.edu

Principal Investigator:

James L. Wilder

Scott and White Memorial Hospital

Recruiting

Temple, Texas, United States, 76508

Contacts

Site Public Contact

254-724-5407

Principal Investigator:

Lucas Wong

Ballad Health Cancer Care - Bristol

Recruiting

Bristol, Virginia, United States, 24201

Contacts

Site Public Contact

423-431-5654charles.mays@balladhealth.org

Principal Investigator:

Asheesh Shipstone

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Site Public Contact

434-243-6303uvacancertrials@hscmail.mcc.virginia.edu

Principal Investigator:

Matthew J. Reilley

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Site Public Contact

703-720-5210Stephanie.VanBebber@inova.org

Principal Investigator:

Timothy L. Cannon

Inova Fairfax Hospital

Recruiting

Falls Church, Virginia, United States, 22042

Contacts

Site Public Contact

703-208-6650Stephanie.VanBebber@inova.org

Principal Investigator:

Timothy L. Cannon

Carilion Roanoke Memorial Hospital

Recruiting

Roanoke, Virginia, United States, 24033

Contacts

Site Public Contact

540-981-7377

Principal Investigator:

Chelsea Salyer

Swedish Cancer Institute-Edmonds

Recruiting

Edmonds, Washington, United States, 98026

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Swedish Cancer Institute-Issaquah

Recruiting

Issaquah, Washington, United States, 98029

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Site Public Contact

206-215-2343PCRC-NCORP@Swedish.org

Principal Investigator:

Dan S. Zuckerman

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Site Public Contact

304-293-7374cancertrialsinfo@hsc.wvu.edu

Principal Investigator:

Mohammed Almubarak

Duluth Clinic Ashland

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Marshfield Medical Center-EC Cancer Center

Recruiting

Eau Claire, Wisconsin, United States, 54701

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Adedayo A. Onitilo

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Site Public Contact

920-433-8889WI_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Gundersen Lutheran Medical Center

Recruiting

La Crosse, Wisconsin, United States, 54601

Contacts

Site Public Contact

608-775-2385cancerctr@gundersenhealth.org

Principal Investigator:

Collin D. Driscoll

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Adedayo A. Onitilo

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, United States, 54548

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Adedayo A. Onitilo

Cancer Center of Western Wisconsin

Recruiting

New Richmond, Wisconsin, United States, 54017

Contacts

Site Public Contact

952-993-1517mmcorc@healthpartners.com

Principal Investigator:

Yan Ji

Saint Vincent Hospital Cancer Center at Oconto Falls

Recruiting

Oconto Falls, Wisconsin, United States, 54154

Contacts

Site Public Contact

920-433-8889WI_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Marshfield Medical Center-Rice Lake

Recruiting

Rice Lake, Wisconsin, United States, 54868

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Adedayo A. Onitilo

Saint Vincent Hospital Cancer Center at Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, United States, 54482

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Adedayo A. Onitilo

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Recruiting

Sturgeon Bay, Wisconsin, United States, 54235-1495

Contacts

Site Public Contact

920-433-8889wi_research_admin@hshs.org

Principal Investigator:

Matthew L. Ryan

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Site Public Contact

800-782-8581oncology.clinical.trials@marshfieldresearch.org

Principal Investigator:

Adedayo A. Onitilo

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Sep 4, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-09-04.