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Trial Title: Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)

NCT ID: NCT06126276

Condition: Malignant Female Reproductive System Neoplasm
Malignant Solid Neoplasm
Recurrent Malignant Female Reproductive System Neoplasm
Recurrent Malignant Solid Neoplasm

Conditions: Official terms:
Neoplasms
Genital Neoplasms, Female
Recurrence
Palbociclib
Maleic acid
Neratinib

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biopsy
Description: Undergo tumor biopsy
Arm group label: Arm I (neratinib maleate)
Arm group label: Arm II (neratinib maleate, palbociclib)

Other name: BIOPSY_TYPE

Other name: Bx

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo collection of blood samples
Arm group label: Arm I (neratinib maleate)
Arm group label: Arm II (neratinib maleate, palbociclib)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Procedure
Intervention name: Computed Tomography
Description: Undergo CT scan
Arm group label: Arm I (neratinib maleate)
Arm group label: Arm II (neratinib maleate, palbociclib)

Other name: CAT

Other name: CAT Scan

Other name: Computed Axial Tomography

Other name: Computerized Axial Tomography

Other name: Computerized axial tomography (procedure)

Other name: Computerized Tomography

Other name: Computerized Tomography (CT) scan

Other name: CT

Other name: CT Scan

Other name: tomography

Intervention type: Procedure
Intervention name: Echocardiography
Description: Undergo ECHO
Arm group label: Arm I (neratinib maleate)
Arm group label: Arm II (neratinib maleate, palbociclib)

Other name: EC

Intervention type: Procedure
Intervention name: Magnetic Resonance Imaging
Description: Undergo MRI
Arm group label: Arm I (neratinib maleate)
Arm group label: Arm II (neratinib maleate, palbociclib)

Other name: Magnetic Resonance

Other name: Magnetic Resonance Imaging (MRI)

Other name: Magnetic resonance imaging (procedure)

Other name: Magnetic Resonance Imaging Scan

Other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

Other name: MR

Other name: MR Imaging

Other name: MRI

Other name: MRI Scan

Other name: MRIs

Other name: NMR Imaging

Other name: NMRI

Other name: Nuclear Magnetic Resonance Imaging

Other name: sMRI

Other name: Structural MRI

Intervention type: Procedure
Intervention name: Multigated Acquisition Scan
Description: Undergo MUGA
Arm group label: Arm I (neratinib maleate)
Arm group label: Arm II (neratinib maleate, palbociclib)

Other name: Blood Pool Scan

Other name: Equilibrium Radionuclide Angiography

Other name: Gated Blood Pool Imaging

Other name: Gated Heart Pool Scan

Other name: MUGA

Other name: MUGA Scan

Other name: Multi-Gated Acquisition Scan

Other name: Radionuclide Ventriculogram Scan

Other name: Radionuclide Ventriculography

Other name: RNV Scan

Other name: RNVG

Other name: SYMA Scanning

Other name: Synchronized Multigated Acquisition Scanning

Intervention type: Drug
Intervention name: Neratinib Maleate
Description: Given PO
Arm group label: Arm I (neratinib maleate)
Arm group label: Arm II (neratinib maleate, palbociclib)

Other name: 2-Butenamide, N-(4-((3-chloro-4-(2-pyridinylmethoxy)phenyl)amino)-3-cyano-7-ethoxy-6-quinolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:1)

Other name: HKI-272 Maleate

Other name: NERATINIB MALEATE ANHYDROUS

Other name: Nerlynx

Intervention type: Drug
Intervention name: Palbociclib
Description: Given PO
Arm group label: Arm II (neratinib maleate, palbociclib)

Other name: 6-Acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-8h-pyrido(2,3-d)pyrimidin-7-one

Other name: Ibrance

Other name: PD 0332991

Other name: PD 332991

Other name: PD 991

Other name: PD-0332991

Other name: PD0332991

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.

Detailed description: PRIMARY OBJECTIVE: I. To investigate the efficacy of neratinib plus palbociclib (PD-0332991) compared to neratinib maleate (neratinib) alone in patients with HER2+ gynecologic cancers and HER2+ solid tumors by evaluating progression-free survival (PFS). SECONDARY OBJECTIVES: I. To investigate outcome in terms of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. II. To investigate clinical benefit rate (ORR + stable disease at 16 weeks). III. To evaluate overall (OS) survival. IV. To evaluate the ORR of patients who crossed over from neratinib monotherapy to neratinib-palbociclib combination. V. To investigate adverse events especially grade 3 and 4 toxicities by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. VI. Collect tissue and provide it to the ComboMATCH Registration Protocol to assess concordance between the diagnostic tumor mutation profile generated by the Designated Laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor-derived deoxyribonucleic acid (ctDNA) mutation profile from plasma, as described in ComboMATCH Registration Protocol. EXPLORATORY TRANSLATIONAL OBJECTIVES: I. To investigate the role of ctDNA-HER2 status at baseline and during follow up to assess if it predicts response to therapy and disease progression and if it does correlate with tumor tissue based HER2 status. II. To investigate if activation of the pathways of interest (PI3K/mTOR and RB1, CCND1-CDK4/6 CDK and RAS/RAF/MAPK) in tumor tissue as well as blood/ctDNA correlate with response or resistance to therapy. III. To correlate extent of HER2 amplification with response to treatment and with HER2 expression by immunohistochemistry or fluorescence in situ hybridization (FISH). IV. To correlate the extent of HER2 amplification with HER2 expression by RNA and protein immunohistochemistry (IHC) analyses and FISH. V. To correlate expression of Rb1, CCND1, CCNE1, CDK4/6 protein expression with response to treatment. VI. Assess alteration in RB1-CDK pathway in neratinib resistant patients at time of progression on monotherapy compared to combination neratinib-palbociclib. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive neratinib maleate orally (PO) once daily (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 echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) during screening and on study, and computed tomography (CT) or magnetic resonance imaging (MRI) and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study. ARM II: 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. After completion of study treatment, patients are followed up every 3 months for 2 years.

Criteria for eligibility:
Criteria:
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. Patient's cancer must have HER2 amplification as defined with ≥ 7 copies by next generation sequencing (NGS) testing - 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, is allowed - One prior line of anti-HER2 therapy is allowed except tyrosine kinase inhibitors (TKI) such as neratinib or tucatinib or antibody drug conjugates (ADC) such as DS8201a or T-DM1 - 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 - 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: University of Alabama at Birmingham Cancer Center

Address:
City: Birmingham
Zip: 35233
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 205-934-0220
Email: tmyrick@uab.edu

Investigator:
Last name: Rebecca C. Arend
Email: Principal Investigator

Facility:
Name: University of South Alabama Mitchell Cancer Institute

Address:
City: Mobile
Zip: 36688
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 251-445-9870
Email: pfrancisco@usouthal.edu

Investigator:
Last name: Ahmed Abdalla
Email: Principal Investigator

Facility:
Name: Saint Alphonsus Cancer Care Center-Boise

Address:
City: Boise
Zip: 83706
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Boise

Address:
City: Boise
Zip: 83712
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Dan S. Zuckerman
Email: Principal Investigator

Facility:
Name: Saint Alphonsus Cancer Care Center-Caldwell

Address:
City: Caldwell
Zip: 83605
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Kootenai Health - Coeur d'Alene

Address:
City: Coeur d'Alene
Zip: 83814
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Fruitland

Address:
City: Fruitland
Zip: 83619
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Dan S. Zuckerman
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Meridian

Address:
City: Meridian
Zip: 83642
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Dan S. Zuckerman
Email: Principal Investigator

Facility:
Name: Saint Alphonsus Cancer Care Center-Nampa

Address:
City: Nampa
Zip: 83687
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Saint Luke's Cancer Institute - Nampa

Address:
City: Nampa
Zip: 83687
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 208-381-2774
Email: eslinget@slhs.org

Investigator:
Last name: Dan S. Zuckerman
Email: Principal Investigator

Facility:
Name: Kootenai Clinic Cancer Services - Post Falls

Address:
City: Post Falls
Zip: 83854
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Kootenai Clinic Cancer Services - Sandpoint

Address:
City: Sandpoint
Zip: 83864
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: John H Stroger Jr Hospital of Cook County

Address:
City: Chicago
Zip: 60612
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 312-864-5204

Investigator:
Last name: Thomas E. Lad
Email: Principal Investigator

Facility:
Name: Carle at The Riverfront

Address:
City: Danville
Zip: 61832
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-446-5532
Email: Research@Carle.com

Investigator:
Last name: Maria T. Grosse-Perdekamp
Email: Principal Investigator

Facility:
Name: Cancer Care Specialists of Illinois - Decatur

Address:
City: Decatur
Zip: 62526
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-876-4762
Email: morganthaler.jodi@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Decatur Memorial Hospital

Address:
City: Decatur
Zip: 62526
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-876-4762
Email: morganthaler.jodi@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Carle Physician Group-Effingham

Address:
City: Effingham
Zip: 62401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-446-5532
Email: Research@carle.com

Investigator:
Last name: Maria T. Grosse-Perdekamp
Email: Principal Investigator

Facility:
Name: Crossroads Cancer Center

Address:
City: Effingham
Zip: 62401
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-876-4762
Email: morganthaler.jodi@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Carle Physician Group-Mattoon/Charleston

Address:
City: Mattoon
Zip: 61938
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-446-5532
Email: Research@carle.com

Investigator:
Last name: Maria T. Grosse-Perdekamp
Email: Principal Investigator

Facility:
Name: Southern Illinois University School of Medicine

Address:
City: Springfield
Zip: 62702
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-545-7929

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Springfield Clinic

Address:
City: Springfield
Zip: 62702
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-444-7541

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Memorial Medical Center

Address:
City: Springfield
Zip: 62781
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 217-528-7541
Email: pallante.beth@mhsil.com

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Carle Cancer Center

Address:
City: Urbana
Zip: 61801
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-446-5532
Email: Research@carle.com

Investigator:
Last name: Maria T. Grosse-Perdekamp
Email: Principal Investigator

Facility:
Name: Mission Cancer and Blood - Ankeny

Address:
City: Ankeny
Zip: 50023
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-282-2921

Investigator:
Last name: Richard L. Deming
Email: Principal Investigator

Facility:
Name: Mission Cancer and Blood - Des Moines

Address:
City: Des Moines
Zip: 50309
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 515-241-3305

Investigator:
Last name: Seema Harichand-Herdt
Email: Principal Investigator

Facility:
Name: Lafayette Family Cancer Center-EMMC

Address:
City: Brewer
Zip: 04412
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-987-3005

Investigator:
Last name: Sarah J. Sinclair
Email: Principal Investigator

Facility:
Name: University of Maryland/Greenebaum Cancer Center

Address:
City: Baltimore
Zip: 21201
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-888-8823

Investigator:
Last name: Ranee Mehra
Email: Principal Investigator

Facility:
Name: National Institutes of Health Clinical Center

Address:
City: Bethesda
Zip: 20892
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-411-1222

Investigator:
Last name: Sarah Shin
Email: Principal Investigator

Facility:
Name: UPMC Western Maryland

Address:
City: Cumberland
Zip: 21502
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 240-964-1400

Investigator:
Last name: Haider S. Mahdi
Email: Principal Investigator

Facility:
Name: Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Address:
City: Ann Arbor
Zip: 48106
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Brighton

Address:
City: Brighton
Zip: 48114
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Canton

Address:
City: Canton
Zip: 48188
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Address:
City: Chelsea
Zip: 48118
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Corewell Health Dearborn Hospital

Address:
City: Dearborn
Zip: 48124
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-551-7695

Investigator:
Last name: Dana Zakalik
Email: Principal Investigator

Facility:
Name: OSF Saint Francis Hospital and Medical Group

Address:
City: Escanaba
Zip: 49829
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 920-433-8889
Email: ewd_research_admin@hshs.org

Investigator:
Last name: Matthew L. Ryan
Email: Principal Investigator

Facility:
Name: Corewell Health Farmington Hills Hospital

Address:
City: Farmington Hills
Zip: 48336
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-551-7695

Investigator:
Last name: Dana Zakalik
Email: Principal Investigator

Facility:
Name: Genesee Cancer and Blood Disease Treatment Center

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Genesee Hematology Oncology PC

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Genesys Hurley Cancer Institute

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Hurley Medical Center

Address:
City: Flint
Zip: 48503
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 810-762-8038
Email: wstrong@ghci.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: University of Michigan Health - Sparrow Lansing

Address:
City: Lansing
Zip: 48912
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 517-364-3712
Email: harsha.trivedi@umhsparrow.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Trinity Health Saint Mary Mercy Livonia Hospital

Address:
City: Livonia
Zip: 48154
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Corewell Health William Beaumont University Hospital

Address:
City: Royal Oak
Zip: 48073
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-551-7695

Investigator:
Last name: Dana Zakalik
Email: Principal Investigator

Facility:
Name: Corewell Health Beaumont Troy Hospital

Address:
City: Troy
Zip: 48085
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 248-551-7695

Investigator:
Last name: Dana Zakalik
Email: Principal Investigator

Facility:
Name: Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Address:
City: Ypsilanti
Zip: 48197
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 734-712-7251
Email: MCRCwebsitecontactform@stjoeshealth.org

Investigator:
Last name: Tareq Al baghdadi
Email: Principal Investigator

Facility:
Name: Essentia Health - Deer River Clinic

Address:
City: Deer River
Zip: 56636
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Essentia Health Cancer Center

Address:
City: Duluth
Zip: 55805
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Essentia Health Hibbing Clinic

Address:
City: Hibbing
Zip: 55746
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Saint John's Hospital - Healtheast

Address:
City: Maplewood
Zip: 55109
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Investigator:
Last name: Yan Ji
Email: Principal Investigator

Facility:
Name: Essentia Health Sandstone

Address:
City: Sandstone
Zip: 55072
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Essentia Health Virginia Clinic

Address:
City: Virginia
Zip: 55792
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Saint Francis Medical Center

Address:
City: Cape Girardeau
Zip: 63703
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 573-334-2230
Email: sfmc@sfmc.net

Investigator:
Last name: Bryan A. Faller
Email: Principal Investigator

Facility:
Name: Community Hospital of Anaconda

Address:
City: Anaconda
Zip: 59711
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Billings Clinic Cancer Center

Address:
City: Billings
Zip: 59101
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-996-2663
Email: research@billingsclinic.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Bozeman Health Deaconess Hospital

Address:
City: Bozeman
Zip: 59715
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Benefis Sletten Cancer Institute

Address:
City: Great Falls
Zip: 59405
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Kalispell Regional Medical Center

Address:
City: Kalispell
Zip: 59901
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Community Medical Center

Address:
City: Missoula
Zip: 59804
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: OptumCare Cancer Care at Seven Hills

Address:
City: Henderson
Zip: 89052
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 702-384-0013
Email: research@sncrf.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: OptumCare Cancer Care at Charleston

Address:
City: Las Vegas
Zip: 89102
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 702-384-0013
Email: research@sncrf.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: OptumCare Cancer Care at Fort Apache

Address:
City: Las Vegas
Zip: 89148
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 702-384-0013
Email: research@sncrf.org

Investigator:
Last name: John A. Ellerton
Email: Principal Investigator

Facility:
Name: Jersey City Medical Center

Address:
City: Jersey City
Zip: 07302
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-339-5294
Email: Roster@nrgoncology.org

Investigator:
Last name: Eugenia Girda
Email: Principal Investigator

Facility:
Name: Monmouth Medical Center Southern Campus

Address:
City: Lakewood
Zip: 08701
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 732-923-6564
Email: mary.danish@rwjbh.org

Investigator:
Last name: Eugenia Girda
Email: Principal Investigator

Facility:
Name: Monmouth Medical Center

Address:
City: Long Branch
Zip: 07740
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 732-923-6564
Email: mary.danish@rwjbh.org

Investigator:
Last name: Eugenia Girda
Email: Principal Investigator

Facility:
Name: Rutgers Cancer Institute of New Jersey

Address:
City: New Brunswick
Zip: 08903
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 732-235-7356

Investigator:
Last name: Eugenia Girda
Email: Principal Investigator

Facility:
Name: Community Medical Center

Address:
City: Toms River
Zip: 08755
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 732-557-8294
Email: Lennette.Gonzales@rwjbh.org

Investigator:
Last name: Eugenia Girda
Email: Principal Investigator

Facility:
Name: Roswell Park Cancer Institute

Address:
City: Buffalo
Zip: 14263
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-767-9355
Email: askroswell@roswellpark.org

Investigator:
Last name: Ellis G. Levine
Email: Principal Investigator

Facility:
Name: State University of New York Upstate Medical University

Address:
City: Syracuse
Zip: 13210
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 315-464-5476

Investigator:
Last name: Mary J. Cunningham
Email: Principal Investigator

Facility:
Name: Southeastern Medical Oncology Center-Clinton

Address:
City: Clinton
Zip: 28328
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 919-587-9084
Email: jfields@cancersmoc.com

Investigator:
Last name: Samer S. Kasbari
Email: Principal Investigator

Facility:
Name: Duke University Medical Center

Address:
City: Durham
Zip: 27710
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 888-275-3853

Investigator:
Last name: Angeles A. Secord
Email: Principal Investigator

Facility:
Name: Southeastern Medical Oncology Center-Goldsboro

Address:
City: Goldsboro
Zip: 27534
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 919-587-9084
Email: jfields@cancersmoc.com

Investigator:
Last name: Samer S. Kasbari
Email: Principal Investigator

Facility:
Name: Southeastern Medical Oncology Center-Jacksonville

Address:
City: Jacksonville
Zip: 28546
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 910-587-9084
Email: jfields@cancersmoc.com

Investigator:
Last name: Samer S. Kasbari
Email: Principal Investigator

Facility:
Name: Duke Women's Cancer Care Raleigh

Address:
City: Raleigh
Zip: 27607
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 919-785-4878

Investigator:
Last name: Angeles A. Secord
Email: Principal Investigator

Facility:
Name: Miami Valley Hospital South

Address:
City: Centerville
Zip: 45459
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Miami Valley Hospital

Address:
City: Dayton
Zip: 45409
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Premier Blood and Cancer Center

Address:
City: Dayton
Zip: 45409
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-276-8320

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Dayton Physician LLC - Englewood

Address:
City: Dayton
Zip: 45415
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Howard M. Gross
Email: Principal Investigator

Facility:
Name: Miami Valley Hospital North

Address:
City: Dayton
Zip: 45415
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Atrium Medical Center-Middletown Regional Hospital

Address:
City: Franklin
Zip: 45005-1066
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Miami Valley Cancer Care and Infusion

Address:
City: Greenville
Zip: 45331
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-569-7515

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: Kettering Medical Center

Address:
City: Kettering
Zip: 45429
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Howard M. Gross
Email: Principal Investigator

Facility:
Name: Upper Valley Medical Center

Address:
City: Troy
Zip: 45373
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 937-528-2900
Email: clinical.trials@daytonncorp.org

Investigator:
Last name: Tarek M. Sabagh
Email: Principal Investigator

Facility:
Name: University of Oklahoma Health Sciences Center

Address:
City: Oklahoma City
Zip: 73104
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Investigator:
Last name: Sagila George
Email: Principal Investigator

Facility:
Name: Saint Alphonsus Cancer Care Center-Ontario

Address:
City: Ontario
Zip: 97914
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Investigator:
Last name: John M. Schallenkamp
Email: Principal Investigator

Facility:
Name: Providence Portland Medical Center

Address:
City: Portland
Zip: 97213
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Investigator:
Last name: Dan S. Zuckerman
Email: Principal Investigator

Facility:
Name: Providence Saint Vincent Medical Center

Address:
City: Portland
Zip: 97225
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

Investigator:
Last name: Dan S. Zuckerman
Email: Principal Investigator

Facility:
Name: UPMC Altoona

Address:
City: Altoona
Zip: 16601
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-339-5294
Email: Roster@nrgoncology.org

Investigator:
Last name: Haider S. Mahdi
Email: Principal Investigator

Facility:
Name: UPMC Hillman Cancer Center Erie

Address:
City: Erie
Zip: 16505
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-389-5208
Email: haneydl@upmc.edu

Investigator:
Last name: Haider S. Mahdi
Email: Principal Investigator

Facility:
Name: UPMC Cancer Centers - Arnold Palmer Pavilion

Address:
City: Greensburg
Zip: 15601
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 724-838-1900

Investigator:
Last name: Haider S. Mahdi
Email: Principal Investigator

Facility:
Name: UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

Address:
City: Mechanicsburg
Zip: 17050
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-389-5208
Email: haneydl@upmc.edu

Investigator:
Last name: Haider S. Mahdi
Email: Principal Investigator

Facility:
Name: UPMC Hillman Cancer Center - Monroeville

Address:
City: Monroeville
Zip: 15146
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-389-5208
Email: haneydl@upmc.edu

Investigator:
Last name: Haider S. Mahdi
Email: Principal Investigator

Facility:
Name: Thomas Jefferson University Hospital

Address:
City: Philadelphia
Zip: 19107
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 215-600-9151
Email: ONCTrialNow@jefferson.edu

Investigator:
Last name: Mitchell I. Edelson
Email: Principal Investigator

Facility:
Name: University of Pittsburgh Cancer Institute (UPCI)

Address:
City: Pittsburgh
Zip: 15232
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-647-8073

Investigator:
Last name: Haider S. Mahdi
Email: Principal Investigator

Facility:
Name: UPMC-Passavant Hospital

Address:
City: Pittsburgh
Zip: 15237
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 412-367-6454

Investigator:
Last name: Haider S. Mahdi
Email: Principal Investigator

Facility:
Name: Asplundh Cancer Pavilion

Address:
City: Willow Grove
Zip: 19090
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 215-600-9151
Email: ONCTrialNow@jefferson.edu

Investigator:
Last name: Mitchell I. Edelson
Email: Principal Investigator

Facility:
Name: M D Anderson Cancer Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 877-632-6789
Email: askmdanderson@mdanderson.org

Investigator:
Last name: Sarina A. Piha-Paul
Email: Principal Investigator

Facility:
Name: University of Virginia Cancer Center

Address:
City: Charlottesville
Zip: 22908
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 434-243-6303
Email: uvacancertrials@hscmail.mcc.virginia.edu

Investigator:
Last name: Matthew J. Reilley
Email: Principal Investigator

Facility:
Name: Inova Schar Cancer Institute

Address:
City: Fairfax
Zip: 22031
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 703-720-5210
Email: Stephanie.VanBebber@inova.org

Investigator:
Last name: Timothy L. Cannon
Email: Principal Investigator

Facility:
Name: Inova Fairfax Hospital

Address:
City: Falls Church
Zip: 22042
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 703-208-6650
Email: Stephanie.VanBebber@inova.org

Investigator:
Last name: Timothy L. Cannon
Email: Principal Investigator

Facility:
Name: Duluth Clinic Ashland

Address:
City: Ashland
Zip: 54806
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 218-786-3308
Email: CancerTrials@EssentiaHealth.org

Investigator:
Last name: Bret E. Friday
Email: Principal Investigator

Facility:
Name: Marshfield Medical Center-EC Cancer Center

Address:
City: Eau Claire
Zip: 54701
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org

Investigator:
Last name: Adedayo A. Onitilo
Email: Principal Investigator

Facility:
Name: Saint Vincent Hospital Cancer Center Green Bay

Address:
City: Green Bay
Zip: 54301
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 920-433-8889
Email: ewd_research_admin@hshs.org

Investigator:
Last name: Matthew L. Ryan
Email: Principal Investigator

Facility:
Name: Saint Vincent Hospital Cancer Center at Saint Mary's

Address:
City: Green Bay
Zip: 54303
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 920-433-8889
Email: ewd_research_admin@hshs.org

Investigator:
Last name: Matthew L. Ryan
Email: Principal Investigator

Facility:
Name: Gundersen Lutheran Medical Center

Address:
City: La Crosse
Zip: 54601
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 608-775-2385
Email: cancerctr@gundersenhealth.org

Investigator:
Last name: Collin D. Driscoll
Email: Principal Investigator

Facility:
Name: Saint Vincent Hospital Cancer Center at Oconto Falls

Address:
City: Oconto Falls
Zip: 54154
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 920-433-8889
Email: ewd_research_admin@hshs.org

Investigator:
Last name: Matthew L. Ryan
Email: Principal Investigator

Facility:
Name: Saint Vincent Hospital Cancer Center at Sheboygan

Address:
City: Sheboygan
Zip: 53081
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 920-433-8889
Email: ewd_research_admin@hshs.org

Investigator:
Last name: Matthew L. Ryan
Email: Principal Investigator

Facility:
Name: Marshfield Medical Center-River Region at Stevens Point

Address:
City: Stevens Point
Zip: 54482
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org

Investigator:
Last name: Adedayo A. Onitilo
Email: Principal Investigator

Facility:
Name: Saint Vincent Hospital Cancer Center at Sturgeon Bay

Address:
City: Sturgeon Bay
Zip: 54235-1495
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 920-433-8889
Email: ewd_research_admin@hshs.org

Investigator:
Last name: Matthew L. Ryan
Email: Principal Investigator

Facility:
Name: Marshfield Medical Center - Weston

Address:
City: Weston
Zip: 54476
Country: United States

Status: Recruiting

Contact:
Last name: Site Public Contact

Phone: 800-782-8581
Email: oncology.clinical.trials@marshfieldresearch.org

Investigator:
Last name: Adedayo A. Onitilo
Email: Principal Investigator

Start date: May 7, 2024

Completion date: April 30, 2025

Lead sponsor:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: National Cancer Institute (NCI)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06126276

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