Recruiting
Phase 2

Targeted Treatment

Sponsor:

Alliance for Clinical Trials in Oncology

Code:

NCT06632977

Conditions

Castration-Resistant Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Genetic testing

Valemetostat Tosylate

Magnetic Resonance Imaging

Computed Tomography

Bone scan

Study Details

Brief summary:

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Conditions

Castration-Resistant Prostate Carcinoma

Stage IVB Prostate Cancer AJCC v8

Study ID

NCT06632977

Start date

Feb 6, 2025

Status verified date

Oct, 2026

Completion date

Oct 11, 2034

Anticipated

Primary completion date

Apr 11, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • PRE-REGISTRATION: Histological or cytological evidence of prostate cancer. Patients with variant histologies including neuroendocrine, small cell and sarcomatoid prostate cancer are allowed to enroll and these will not be used as selection criteria for individual arms. Central pathology review is not required.
  • PRE-REGISTRATION: Measurable disease and/or non-measurable metastatic disease per RECIST version 1.1.
  • PRE-REGISTRATION: Tissue procured within 12 months of pre-registration (metastatic disease preferred over primary tissue, though both are acceptable) available for submission per Section 6.2. For patients who have progressed on A032102 and are pre-registering again, repeat tissue procurement will not be mandated.
  • PRE-REGISTRATION: Molecular report available performed as part of standard of care testing via any Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing (NGS) assay. Patients may be assigned based on pre-determined qualifying molecular/DNA alterations as stated in Section 4.8 after receipt of local molecular testing by the A032102 molecular tumor board (MTB). Final determination of arm assignment will be determined by the MTB. For qualifying DNA alteration determined by the MTB, testing may be from tumor tissue collected at any time or circulating tumor DNA (ctDNA) within 12 months of pre-registration. If no qualifying DNA alteration is identified based on the CLIA-certified next generation sequencing assay and MTB review, Caris testing, should be performed for both DNA/RNA profiling. Arm assignment based RNA requires testing of tumor tissue collected within 12 months of pre-registration and MTB review.
  • PRE-REGISTRATION: Age ≥ 18 years.
  • REGISTRATION: Progressive mCRPC as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND one or more of the following criteria (choose all the apply):

  • PSA progression, defined by at least 2 consecutive rising PSA values at a minimum of 1-week intervals with the most recent PSA value being 2.0 ng/mL or higher, if confirmed PSA rise is the only indication of progression. Patients who received an anti-androgen must have PSA progression after withdrawal of anti-androgen therapy.
  • Radiographic progression per RECIST 1.1 criteria for soft tissue lesions
  • Bone metastasis progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
  • REGISTRATION: Patients selected to receive lutetium Lu 177 vipivotide tetraxetan treatment are required to have prostate-specific membrane antigen (PSMA) positive mCRPC as determined by investigator assessment. For reference, in the VISION trial this was defined as at least 1 PSMA+ metastatic lesion (defined as uptake greater than that of liver parenchyma in lesions of any size in any organ system) and no PSMA- lesions (defined as uptake equal to or lower than that of liver parenchyma in any lymph node with a short axis of at least 2.5 cm, in any solid organ lesion with a short axis of at least 1.0 cm, or in any bone lesion with a soft-tissue component of at least 1.0 cm in the short axis).
  • REGISTRATION: Prior treatment with androgen receptor signaling inhibitor (ARSI) in either the metastatic hormone sensitive setting or mCRPC is required. Prior taxane therapy in either metastatic hormone sensitive setting or mCRPC is mandated unless patient is taxane ineligible or the patient refuses taxane therapy. Prior lutetium LU177 vipivotide tetraxetan treatment is permitted but not mandated. Patients with known germline or somatic deleterious BRCA 1/2 mutations must have received a prior PARPi.
  • REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:

  • Chemotherapy-induced neuropathy
  • Fatigue
  • Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)
  • REGISTRATION: No cytotoxic, biologic, radiopharmaceutical or other non-kinase inhibitor investigational agent within 4 weeks of registration. Treatment with any type of small molecular kinase inhibitor (including investigational kinase inhibitor) within 2 weeks of registration. Treatment with abiraterone acetate, apalutamide, or darolutamide within 2 weeks of registration. Treatment with enzalutamide within 4 weeks of registration. No treatment with radiation therapy within 2 weeks of registration.
  • REGISTRATION: No major surgery within 4 weeks of registration.
  • REGISTRATION: No prior treatment with EZH inhibitors.
  • REGISTRATION: Prior treatment with cabazitaxel + carboplatin.
  • REGISTRATION: None of the following conditions:

  • Current use of moderate or strong cytochrome P450 (CYP)3A inducers.
  • Known or suspected hypersensitivity to valemetostat tosylate (DS-3201b) or any of the excipients.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

\* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • Imminent or established spinal cord compression based on clinical and/or imaging findings.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before registration.
  • Significant cardiovascular defined as:
  • Myocardial infarction within 6 months prior to enrollment.
  • Uncontrolled angina pectoris within 6 months prior to enrollment.
  • New York Heart Association Class 3 or 4 congestive heart failure.
  • Corrected QT interval calculated by the Fridericia\'s formula (QTcF) ≥ 470 ms per electrocardiogram (ECG) within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF. Patients with known history or current symptoms of cardiac disease, history of treatment with cardiotoxic agents, or agents/conditions known to impact QTcF should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and ECG.
  • Uncontrolled hypertension (resting systolic blood pressure \>160 mmHg or diastolic blood pressure \> 100 mmHg).
  • Clinically significant acute infection requiring systemic antibacterial, antifungal or antiviral therapy.
  • Moderate to severe hepatic impairment (Child-Pugh Class C)
  • REGISTRATION: No freezing or donating sperm ≤ 14 days prior to registration.
  • REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • REGISTRATION: No granulocyte colony-stimulating factor (GCSF) within 2 weeks of registration.
  • REGISTRATION: No red blood cell (RBC) transfusions within 2 weeks of registration.
  • REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • REGISTRATION: No bleeding diathesis.
  • REGISTRATION: White blood cell count (WBC) ≥ 2,500/mcL.
  • REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,500/mcL.
  • REGISTRATION: Hemoglobin ≥ 9 g/dL.
  • REGISTRATION: Platelet count ≥ 100,000/mcL.
  • REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x upper limit of normal \[ULN\] for subjects with documented Gilbert\'s disease).
  • REGISTRATION: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN.
  • REGISTRATION: Albumin ≥ 2.8 g/dL.
  • REGISTRATION: The A032102 molecular tumor board will review the local pathology report and molecular sequencing report, and the Alliance registration/randomization office will relay the assignment to the submitting site. Once the site receives this assignment, they can register the patient to A032102. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.
  • RE-REGISTRATION: Progressive mCRPC (after receiving the tumor board assigned therapy) as defined: 1) castrate levels of serum testosterone \< 50 ng/dL AND 2) progressive disease defined by radiographic progression on conventional imaging (CT/MRI chest, abdomen and pelvis and bone scan within 42 days of re-registration).
  • RE-REGISTRATION: Resolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) resolved to CTCAE version 5.0, grade ≤ 1 or baseline. Note: Subjects may be enrolled with chronic, stable grade 2 toxicities (defined as no worsening to \> grade 2 for at least 3 months prior to registration and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, comprised of:

  • Chemotherapy-induced neuropathy
  • Fatigue
  • Residual toxicities from prior treatment: Grade 1 or grade 2 endocrinopathies which may include: Hypothyroidism/hyperthyroidism. type I diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo).
  • RE-REGISTRATION: None of the following conditions:

  • Imminent or established spinal cord compression based on clinical and/or imaging findings.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to registration after radiotherapy or at least 4 weeks prior to re-registration after major surgery (e.g., removal or biopsy of brain metastasis). Patients must have complete wound healing from major surgery or minor surgery before re-registration.
  • Corrected QT interval calculated by the Fridericia\'s formula (QTcF) \< 470 ms per ECG within 42 days before randomization in any individual with any history of any cardiac disease or medication which can impact QTcF.
  • Significant cardiovascular defined as:
  • Myocardial infarction within 6 months prior to enrollment.
  • Uncontrolled angina pectoris within 6 months prior to enrollment.
  • New York Heart Association Class 3 or 4 congestive heart failure.
  • Uncontrolled hypertension (resting systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg).
  • RE-REGISTRATION: ECOG Performance Status 0-2.
  • RE-REGISTRATION: No GCSF within 2 weeks of registration.
  • RE-REGISTRATION: No RBC transfusions within 2 weeks of registration.
  • RE-REGISTRATION: No platelet transfusions within 2 weeks of registration.
  • RE-REGISTRATION: WBC ≥ 2,500/mcL.
  • RE-REGISTRATION: ANC ≥ 1,500/mcL.
  • RE-REGISTRATION: Hemoglobin ≥ 9 g/dL (transfusions permitted).
  • RE-REGISTRATION: Platelet count ≥ 100,000/mcL.
  • RE-REGISTRATION: Creatinine clearance ≥ 30 mL/min as defined by Cockcroft-Gault equation.
  • RE-REGISTRATION: Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN for subjects with documented Gilbert\'s disease).
  • RE-REGISTRATION: AST and ALT ≤ 3 x ULN.
  • RE-REGISTRATION: Albumin ≥ 2.8 g/dL.
  • RE-REGISTRATION: QT Interval (QTcF) \< 470 ms (in individuals with any cardiac history of any medication or condition known to impact QTcF).
  • RE-REGISTRATION: The A032102 molecular tumor board will review the CARIS molecular sequencing report, the Alliance registration/randomization office will relay the assignment to the site. Any questions about the molecular board treatment assignments can be directed to A032102@alliancenctn.org.

Exclusion Criteria:

\-

Study Design

Enrollment

474 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (genetic testing, valemetostat tosylate)

Patients undergo genetic testing on previously-collected tissue samples. Patients receive valemetostat tosylate PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.

experimental: Arm B (genetic testing, carboplatin, cabazitaxel)

Patients undergo genetic testing on previously-collected tissue samples. Patients receive carboplatin IV over 30 minutes and cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.

experimental: Arm C (genetic testing, physician choice treatment)

Patients undergo genetic testing on previously-collected tissue. Patients receive one of the following treatment regimens per treating physician: 1)Cabazitaxel IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. 2)Abiraterone acetate PO QD on days 1-28 of each cycle and prednisone PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 3) Enzalutamide PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. 4) Lutetium Lu 177 vipivotide tetraxetan IV on day 1 of each cycle. Treatment repeats every 42 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and bone scan throughout the trial. Patients may also undergo optional FDG or PSMA PET, as well as optional blood collection throughout the trial.

Interventions

Genetic testing

undergo genetic testing

Valemetostat Tosylate

Given PO

Magnetic Resonance Imaging

undergo Magnetic Resonance Imaging

Computed Tomography

undergo Computed Tomography

Bone scan

undergo Bone scan

FDG-Positron Emission Tomography

Undergo FDG PET

PSMA PET Scan

Undergo PSMA PET

Biospecimen Collection

undergo blood collection

Carboplatin

Given IV

Cabazitaxel

Given IV

Abiraterone Acetate

Given PO

Enzalutamide

Given PO

Lutetium Lu 177 Vipivotide Tetraxetan

Given IV

Primary outcome measure

  • Objective Response [ Time Frame: Within 6 months from the start of treatment ]

Central Contacts and Locations

Central contacts

Rana McKay, MD

858-822-6185rmckay@health.ucsd.edu

Shiva Baghaie

GUprotocols@alliancenctn.org

Locations

University of Alabama at Birmingham Cancer Center

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Site Public Contact

gingerreeves@uabmc.edu

Principal Investigator:

Joelle Hamilton

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Edward P. Gelmann

University of Arizona Cancer Center-North Campus

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Site Public Contact

UACC-IIT@uacc.arizona.edu

Principal Investigator:

Edward P. Gelmann

Enloe Medical Center

Recruiting

Chico, California, United States, 95926

Contacts

Site Public Contact

530-332-4700

Principal Investigator:

Nicholas Mitsiades

UC San Diego Health System - Encinitas

Recruiting

Encinitas, California, United States, 92024

Contacts

Site Public Contact

760-536-7700

Principal Investigator:

Rana R. McKay

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Recruiting

Irvine, California, United States, 92612

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Arash Rezazadeh Kalebasty

UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Site Public Contact

858-822-5354cancercto@ucsd.edu

Principal Investigator:

Rana R. McKay

UC Irvine Health/Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Site Public Contact

877-827-8839ucstudy@uci.edu

Principal Investigator:

Arash Rezazadeh Kalebasty

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Nicholas Mitsiades

UC San Diego Medical Center - Hillcrest

Recruiting

San Diego, California, United States, 92103

Contacts

Site Public Contact

rhabbaba@health.ucsd.edu

Principal Investigator:

Rana R. McKay

UCHealth Memorial Hospital Central

Recruiting

Colorado Springs, Colorado, United States, 80909

Contacts

Site Public Contact

719-365-2406

Principal Investigator:

Steven R. Schuster

Memorial Hospital North

Recruiting

Colorado Springs, Colorado, United States, 80920

Contacts

Site Public Contact

719-364-6700

Principal Investigator:

Steven R. Schuster

Poudre Valley Hospital

Recruiting

Fort Collins, Colorado, United States, 80524

Contacts

Site Public Contact

970-297-6150

Principal Investigator:

Steven R. Schuster

Cancer Care and Hematology-Fort Collins

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

Site Public Contact

773-702-9171protocols@AllianceNCTN.org

Principal Investigator:

Steven R. Schuster

UCHealth Greeley Hospital

Recruiting

Greeley, Colorado, United States, 80631

Contacts

Site Public Contact

773-702-9171protocols@AllianceNCTN.org

Principal Investigator:

Steven R. Schuster

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Site Public Contact

970-203-7083

Principal Investigator:

Steven R. Schuster

Stamford Hospital/Bennett Cancer Center

Recruiting

Stamford, Connecticut, United States, 06904

Contacts

Site Public Contact

203-323-8944

Principal Investigator:

Anthony P. Gulati

Beebe South Coastal Health Campus

Recruiting

Millville, Delaware, United States, 19967

Contacts

Site Public Contact

302-291-6730research@beebehealthcare.org

Principal Investigator:

Gregory A. Masters

Helen F Graham Cancer Center

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Medical Oncology Hematology Consultants PA

Recruiting

Newark, Delaware, United States, 19713

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Beebe Health Campus

Recruiting

Rehoboth Beach, Delaware, United States, 19971

Contacts

Site Public Contact

302-291-6730research@beebehealthcare.org

Principal Investigator:

Gregory A. Masters

Jupiter Medical Center

Recruiting

Jupiter, Florida, United States, 33458

Contacts

Site Public Contact

561-263-5791clinicaltrials@jupitermed.com

Principal Investigator:

Ryan H. Devine

Tripler Army Medical Center

Recruiting

Honolulu, Hawaii, United States, 96859

Contacts

Site Public Contact

808-433-6336

Principal Investigator:

Karen J. Shou

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Priyank P. Patel

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Priyank P. Patel

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Priyank P. Patel

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

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

Memorial Hospital East

Recruiting

Shiloh, Illinois, United States, 62269

Contacts

Site Public Contact

314-747-9912dschwab@wustl.edu

Principal Investigator:

Eric M. Knoche

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Priyank P. Patel

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Site Public Contact

309-243-3605andersonj@illinoiscancercare.com

Principal Investigator:

Bryan A. Faller

McFarland Clinic - Ames

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-239-4734ksoder@mcfarlandclinic.com

Principal Investigator:

Joseph J. Merchant

University of Iowa Healthcare Cancer Services Quad Cities

Recruiting

Bettendorf, Iowa, United States, 52722

Contacts

Site Public Contact

563-355-7733katherine-daprile@uiowa.edu

Principal Investigator:

Fernando Maciel Barbosa

University of Iowa/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Site Public Contact

800-237-1225

Principal Investigator:

Fernando Maciel Barbosa

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

The University of Kansas Cancer Center - Olathe

Recruiting

Olathe, Kansas, United States, 66061

Contacts

Site Public Contact

913-588-1569OlatheCCResearch@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

University of Kansas Hospital-Indian Creek Campus

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

University of Kansas Health System Saint Francis Campus

Recruiting

Topeka, Kansas, United States, 66606

Contacts

Site Public Contact

785-295-8000

Principal Investigator:

Elizabeth M. Wulff

University of Kansas Hospital-Westwood Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Elizabeth M. Wulff

Saint Elizabeth Healthcare Edgewood

Recruiting

Edgewood, Kentucky, United States, 41017

Contacts

Site Public Contact

859-301-4730Kristi.Curtsinger@stelizabeth.com

Principal Investigator:

Matthew Kurian

Dana-Farber Cancer Institute at Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Site Public Contact

877-338-7425

Principal Investigator:

Daniel Roberts

Dana Farber-Merrimack Valley

Recruiting

Methuen, Massachusetts, United States, 01844

Contacts

Site Public Contact

877-338-7425

Principal Investigator:

Pedro M. Sanz-Altamira

Dana-Farber/Brigham and Women's Cancer Center at Milford Regional

Recruiting

Milford, Massachusetts, United States, 01757

Contacts

Site Public Contact

877-332-4294

Principal Investigator:

Daniel E. Fein

Dana-Farber/Brigham and Women's Cancer Center at South Shore

Recruiting

South Weymouth, Massachusetts, United States, 02190

Contacts

Site Public Contact

781-624-5000

Principal Investigator:

Thomas P. O'Connor

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

Site Public Contact

413-794-3565tamara.wrenn@baystatehealth.org

Principal Investigator:

John C. McCann

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:

Elie G. Dib

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:

Elie G. Dib

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:

Elie G. Dib

University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Site Public Contact

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

Principal Investigator:

Elie G. Dib

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Elie G. Dib

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:

Elie G. Dib

Essentia Health Saint Joseph's Medical Center

Recruiting

Brainerd, Minnesota, United States, 56401

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

Coborn Cancer Center at Saint Cloud Hospital

Recruiting

Saint Cloud, Minnesota, United States, 56303

Contacts

Site Public Contact

877-229-4907coborncancercenter@centracare.com

Principal Investigator:

Donald J. Jurgens

Siteman Cancer Center at Saint Peters Hospital

Recruiting

City of Saint Peters, Missouri, United States, 63376

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Eric M. Knoche

Siteman Cancer Center at West County Hospital

Recruiting

Creve Coeur, Missouri, United States, 63141

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Eric M. Knoche

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Eric M. Knoche

Siteman Cancer Center-South County

Recruiting

St Louis, Missouri, United States, 63129

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Eric M. Knoche

Siteman Cancer Center at Christian Hospital

Recruiting

St Louis, Missouri, United States, 63136

Contacts

Site Public Contact

800-600-3606info@siteman.wustl.edu

Principal Investigator:

Eric M. Knoche

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Site Public Contact

800-996-2663research@billingsclinic.org

Principal Investigator:

John M. Schallenkamp

Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Contacts

Site Public Contact

551-996-2897

Principal Investigator:

Robert S. Alter

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

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Site Public Contact

212-824-7309CCTO@mssm.edu

Principal Investigator:

Eric J. Miller

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Site Public Contact

877-668-0683cancerclinicaltrials@med.unc.edu

Principal Investigator:

Catherine Fahey

Essentia Health Cancer Center-South University Clinic

Recruiting

Fargo, North Dakota, United States, 58103

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Site Public Contact

216-778-7559ababal@metrohealth.org

Principal Investigator:

Joseph Attallah

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066Jamesline@osumc.edu

Principal Investigator:

Timothy D. Gauntner

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:

Adanma Anji Ayanambakkam Attanathi

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Natasha C. Edwin

Providence Saint Vincent Medical Center

Recruiting

Portland, Oregon, United States, 97225

Contacts

Site Public Contact

503-215-2614CanRsrchStudies@providence.org

Principal Investigator:

Natasha C. Edwin

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080trials@ohsu.edu

Principal Investigator:

Alexandra O. Sokolova

Gibbs Cancer Center-Gaffney

Recruiting

Gaffney, South Carolina, United States, 29341

Contacts

Site Public Contact

864-560-6104kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

Gibbs Cancer Center-Pelham

Recruiting

Greer, South Carolina, United States, 29651

Contacts

Site Public Contact

864-560-6104kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

Spartanburg Medical Center

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

Site Public Contact

864-560-6104kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

SMC Center for Hematology Oncology Union

Recruiting

Union, South Carolina, United States, 29379

Contacts

Site Public Contact

864-560-6104kmertz-rivera@gibbscc.org

Principal Investigator:

Michael Humeniuk

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Site Public Contact

214-590-5582canceranswerline@UTSouthwestern.edu

Principal Investigator:

Joseph Vento

UT Southwestern Simmons Cancer Center - RedBird

Recruiting

Dallas, Texas, United States, 75237

Contacts

Site Public Contact

214-648-7097canceranswerline@utsouthwestern.edu

Principal Investigator:

Joseph Vento

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097canceranswerline@UTSouthwestern.edu

Principal Investigator:

Joseph Vento

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:

Joseph Vento

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:

Joseph Vento

Bon Secours Memorial Regional Medical Center

Recruiting

Mechanicsville, Virginia, United States, 23116

Contacts

Site Public Contact

804-893-8978anne_carmellat@bshsi.org

Principal Investigator:

Joseph D. Pennington

Bon Secours Saint Francis Medical Center

Recruiting

Midlothian, Virginia, United States, 23114

Contacts

Site Public Contact

804-893-8978anne_carmellat@bshsi.org

Principal Investigator:

Joseph D. Pennington

Bon Secours Richmond Community Hospital

Recruiting

Richmond, Virginia, United States, 23223

Contacts

Site Public Contact

804-893-8978anne_carmellat@bshsi.org

Principal Investigator:

Joseph D. Pennington

Bon Secours Saint Mary's Hospital

Recruiting

Richmond, Virginia, United States, 23226

Contacts

Site Public Contact

804-893-8978anne_carmellat@bshsi.org

Principal Investigator:

Joseph D. Pennington

Bon Secours Cancer Institute at Reynolds Crossing

Recruiting

Richmond, Virginia, United States, 23230

Contacts

Site Public Contact

804-893-8978Anne_caramella@bshsi.org

Principal Investigator:

Joseph D. Pennington

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Site Public Contact

ctoclinops@vcu.edu

Principal Investigator:

John Melson

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

John Melson

Edwards Comprehensive Cancer Center

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

Site Public Contact

304-399-6566Christina.Cole@chhi.org

Principal Investigator:

Toni O. Pacioles

Marshfield Medical Center-Marshfield

Recruiting

Marshfield, Wisconsin, United States, 54449

Contacts

Site Public Contact

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

Principal Investigator:

Michael Husak

Froedtert Menomonee Falls Hospital

Recruiting

Menomonee Falls, Wisconsin, United States, 53051

Contacts

Site Public Contact

262-257-5100

Principal Investigator:

Kathryn A. Bylow

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Contacts

Site Public Contact

414-805-3666

Principal Investigator:

Kathryn A. Bylow

Drexel Town Square Health Center

Recruiting

Oak Creek, Wisconsin, United States, 53154

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Kathryn A. Bylow

Froedtert West Bend Hospital/Kraemer Cancer Center

Recruiting

West Bend, Wisconsin, United States, 53095

Contacts

Site Public Contact

414-805-0505

Principal Investigator:

Kathryn A. Bylow

More Information

Sponsor

Alliance for Clinical Trials in Oncology

Last update posted

Oct 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-05. This information was provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology on 2026-10-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.