Recruiting
Phase 2

Pembrolizumab & Radiation

Sponsor:

National Cancer Institute (NCI)

Code:

NCT07061964

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Stage II Bladder Cancer AJCC v8

Stage IIIA Bladder Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Cystoscopy

Magnetic Resonance Imaging

Pembrolizumab

Study Details

Brief summary:

This phase II trial tests the effect of giving pembrolizumab in combination with radiation therapy after chemotherapy in preventing surgery to remove the bladder in patients with muscle invasive bladder cancer. Standard of care therapy includes chemotherapy before surgery (neoadjuvant) to shrink or get rid of the tumor. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Photon beam radiation therapy is a type of radiation therapy that uses x-rays or gamma rays that come from a special machine called a linear accelerator. The radiation dose is delivered at the surface of the body and goes into the tumor and through the body. Giving pembrolizumab in combination with radiation therapy after neoadjuvant chemotherapy may help prevent surgical removal of the bladder in patients with muscle invasive bladder cancer.

Conditions

Muscle Invasive Bladder Urothelial Carcinoma

Stage II Bladder Cancer AJCC v8

Stage IIIA Bladder Cancer AJCC v8

Study ID

NCT07061964

Start date

Nov 25, 2025

Status verified date

Jul, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must have histologic evidence of cT2-T4aN0M0 muscle invasive urothelial carcinoma of the bladder within 180 days prior to starting neoadjuvant therapy (NAT)
  • Participants must have had CT chest/abdomen/pelvis (C/A/P), MRI C/A/P or PET within 60 days prior to starting NAT to determine cT2-T4aN0M0
  • Participants must have undergone TURBT with biopsy of areas of prior disease and systematic biopsies (left and right lateral, dome, posterior wall and trigone) and radiologic staging showing clinically T0-T1 disease within 60 days after the last dose of NAT. At least 4 out of 5 systematic biopsies must be performed

  • NOTE: This TURBT must be within 90 days prior to registration. Registration must be within 90 days after the last dose of NAT
  • Participants must have imaging of the chest, abdomen, and pelvis performed using CT or MRI preferably with contrast. Fludeoxyglucose F-18 (FDG) PET-CT can also be used for staging. If FDG PET-CT is used, then it is at the discretion of the investigator if they want to additionally obtain diagnostic CT or MRI with contrast within 60 days after the last dose of NAT
  • Participants with lymph nodes ≥ 1.0 cm in the shortest cross-sectional diameter on imaging (CT or MRI of abdomen and pelvis) after completion of NAT must have a PET-CT within 70 days prior to registration. A biopsy in the setting of negative PET-CT is not required unless there is strong clinical suspicion for nodal involvement with tumor. Participants with a positive PET are deemed ineligible unless a biopsy is performed and shows no evidence of tumor involvement

  • NOTE: For questions regarding the above eligibility criteria, please contact the study chairs in addition to the Southwest Oncology Group (SWOG) Statistics and Data Management Center (SDMC)
  • Participants must not have evidence of ≥ T2, or N1-3, or M1 disease after NAT
  • Participants must not have the presence of small cell, neuroendocrine carcinoma, plasmacytoid variants on any pathology
  • Participants must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within 24 months prior to registration except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract, including renal pelvis or ureter if the participant underwent complete nephroureterectomy

  • NOTE: Participants with mixed variant histology will be eligible for the trial if the majority (> 50%) of the tumor is urothelial cell carcinoma
  • Participants will be allowed to continue PD-1/L-1 inhibitor therapy received as part of standard of care neoadjuvant therapy while they undergo pre-registration assessments (TURBT and imaging)
  • Participants must have received at least 3 and no more than 6 cycles of Food and Drug Administration (FDA) approved NAT for MIBC. These include cisplatin-based combination chemotherapy (e.g. cisplatin and gemcitabine \[GC\] with or without PD-1/L1 inhibitors) dose dense or accelerated methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) or enfortumab vedotin with PD-1/L1 inhibitor
  • Participants must not have had anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody, any other antibody or drug targeting T-cell co-stimulation, enfortumab vedotin, or any other drug targeting nectin-4 other than for neoadjuvant treatment for MIBC

  • NOTE: Prior intravesical immunotherapy or chemotherapy for non-muscle invasive disease is allowed
  • Participants must not have had prior pelvic radiotherapy
  • Participants must not have received a live attenuated vaccination within 28 days prior to registration
  • Participants with conditions requiring immunosuppressive doses of steroids (> 10 mg/day of prednisone or equivalent) or other immunosuppressive medications must not be taking steroids at time of trial registration
  • Participants must be ≥ 18 years old at the time of registration
  • Participants must have Zubrod performance status of 0-2
  • Participants must have a complete medical history and physical exam within 28 days prior to registration
  • Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)
  • Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration)
  • Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
  • Total bilirubin ≤ institutional upper limit of normal (ULN) unless history of Gilbert's disease (within 28 days prior to registration)

  • Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN (within 28 days prior to registration)
  • Participants must have a creatinine ≤ the institutional (I)ULN OR measured OR calculated creatinine clearance ≥ 40 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration
  • Participants 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 II or better
  • Participants with a history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration
  • For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured (defined as undetectable HCV viral load)
  • Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen
  • Participants must be offered the opportunity to participate in specimen banking
  • Participants who can complete the PRO-CTCAE questionnaire in English or Spanish will be offered the opportunity to participate in the optional patient-reported outcome study
  • NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system

  • Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
  • For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and central institutional review board (CIRB) regulations

Study Design

Enrollment

111 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (photon beam RT, pembrolizumab)

Patients undergo photon beam RT QD on Monday-Friday for up to 20 treatments and receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 18 cycles (for a total of 12 months, including NAT) in the absence of disease progression or unacceptable toxicity. Patients also undergo TURBT with tissue sample collection at pre-registration and CT, MRI or PET, cystoscopy, and urine and blood sample collection throughout the study.

Interventions

Biospecimen Collection

Undergo tissue, urine, and blood sample collection

Computed Tomography

Undergo CT

Cystoscopy

Undergo cystoscopy

Magnetic Resonance Imaging

Undergo MRI

Pembrolizumab

Given IV

Photon Beam Radiation Therapy

Undergo photon beam RT

Positron Emission Tomography

Undergo PET

Questionnaire Administration

Ancillary studies

Transurethral Resection of Bladder Tumor

Undergo TURBT

Primary outcome measure

  • Bladder intact event-free survival (BI-EFS) [ Time Frame: Within 3 years after registration ]

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:

Charles C. Peyton

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Site Public Contact

602-747-9738

Principal Investigator:

Chinedu Mmeje

Mayo Clinic Hospital in Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Mark D. Tyson

Highlands Oncology Group - Fayetteville

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Principal Investigator:

Joseph T. Beck

Highlands Oncology Group - Rogers

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Principal Investigator:

Joseph T. Beck

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Principal Investigator:

Joseph T. Beck

Tower Cancer Research Foundation

Recruiting

Beverly Hills, California, United States, 90211

Contacts

Principal Investigator:

Leslie Ballas

City of Hope Corona

Recruiting

Corona, California, United States, 92882

Contacts

Principal Investigator:

Abhishek Tripathi

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Principal Investigator:

Abhishek Tripathi

City of Hope at Irvine Lennar

Recruiting

Irvine, California, United States, 92618

Contacts

Site Public Contact

877-467-3411

Principal Investigator:

Abhishek Tripathi

City of Hope Antelope Valley

Recruiting

Lancaster, California, United States, 93534

Contacts

Principal Investigator:

Abhishek Tripathi

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Principal Investigator:

Siamak Daneshmand

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Siamak Daneshmand

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Principal Investigator:

Leslie Ballas

University of California Davis Comprehensive Cancer Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Site Public Contact

916-734-3089

Principal Investigator:

Mamta Parikh

City of Hope South Pasadena

Recruiting

South Pasadena, California, United States, 91030

Contacts

Principal Investigator:

Abhishek Tripathi

Cedars-Sinai Cancer - Tarzana

Recruiting

Tarzana, California, United States, 91356

Contacts

Site Public Contact

818-981-3818

Principal Investigator:

Leslie Ballas

City of Hope Upland

Recruiting

Upland, California, United States, 91786

Contacts

Principal Investigator:

Abhishek Tripathi

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Tyler Robin

UCHealth - Cherry Creek

Recruiting

Denver, Colorado, United States, 80206

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Tyler Robin

Shaw Cancer Center

Recruiting

Edwards, Colorado, United States, 81632

Contacts

Site Public Contact

970-569-7429

Principal Investigator:

Erin Schwab

Poudre Valley Hospital

Recruiting

Fort Collins, Colorado, United States, 80524

Contacts

Site Public Contact

970-297-6150

Principal Investigator:

Tyler Robin

Cancer Care and Hematology-Fort Collins

Recruiting

Fort Collins, Colorado, United States, 80528

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Tyler Robin

UCHealth Greeley Hospital

Recruiting

Greeley, Colorado, United States, 80631

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Tyler Robin

UCHealth Highlands Ranch Hospital

Recruiting

Highlands Ranch, Colorado, United States, 80129

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Tyler Robin

UCHealth Lone Tree Health Center

Recruiting

Lone Tree, Colorado, United States, 80124

Contacts

Site Public Contact

protocols@swog.org

Principal Investigator:

Tyler Robin

Medical Center of the Rockies

Recruiting

Loveland, Colorado, United States, 80538

Contacts

Site Public Contact

970-203-7083

Principal Investigator:

Tyler Robin

Moffitt Cancer Center at SouthShore

Recruiting

Ruskin, Florida, United States, 33570

Contacts

Principal Investigator:

George D. Grass

Moffitt Cancer Center-International Plaza

Recruiting

Tampa, Florida, United States, 33607

Contacts

Principal Investigator:

George D. Grass

Moffitt Cancer Center - McKinley Campus

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

George D. Grass

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Principal Investigator:

George D. Grass

Moffitt Cancer Center at Wesley Chapel

Recruiting

Wesley Chapel, Florida, United States, 33544

Contacts

Principal Investigator:

George D. Grass

CTCA at Southeastern Regional Medical Center

Recruiting

Newnan, Georgia, United States, 30265

Contacts

Site Public Contact

770-400-6629

Principal Investigator:

Bamidele A. Adesunloye

Rush-Copley Medical Center

Recruiting

Aurora, Illinois, United States, 60504

Contacts

Principal Investigator:

Priyank P. Patel

OSF Saint Joseph Medical Center

Recruiting

Bloomington, Illinois, United States, 61701

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Bloomington

Recruiting

Bloomington, Illinois, United States, 61704

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Canton

Recruiting

Canton, Illinois, United States, 61520

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Carthage

Recruiting

Carthage, Illinois, United States, 62321

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Principal Investigator:

Sean Sachdev

Northwestern Medicine Cancer Center Old Irving Park

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Principal Investigator:

Sean Sachdev

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Principal Investigator:

Priyank P. Patel

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Kishwaukee

Recruiting

DeKalb, Illinois, United States, 60115

Contacts

Principal Investigator:

Sean Sachdev

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Principal Investigator:

Priyank P. Patel

Illinois CancerCare-Eureka

Recruiting

Eureka, Illinois, United States, 61530

Contacts

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:

Nicklas R. Pfanzelter

Illinois CancerCare-Galesburg

Recruiting

Galesburg, Illinois, United States, 61401

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Cancer Center Delnor

Recruiting

Geneva, Illinois, United States, 60134

Contacts

Principal Investigator:

Sean Sachdev

NorthShore University HealthSystem-Glenbrook Hospital

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Nicklas R. Pfanzelter

Northwestern Medicine Glenview Outpatient Center

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Sean Sachdev

Northwestern Medicine Grayslake Outpatient Center

Recruiting

Grayslake, Illinois, United States, 60030

Contacts

Site Public Contact

312-695-1102

Principal Investigator:

Sean Sachdev

NorthShore University HealthSystem-Highland Park Hospital

Recruiting

Highland Park, Illinois, United States, 60035

Contacts

Site Public Contact

847-570-2109

Principal Investigator:

Nicklas R. Pfanzelter

Illinois CancerCare-Kewanee Clinic

Recruiting

Kewanee, Illinois, United States, 61443

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Lake Forest Hospital

Recruiting

Lake Forest, Illinois, United States, 60045

Contacts

Principal Investigator:

Sean Sachdev

Illinois CancerCare-Macomb

Recruiting

Macomb, Illinois, United States, 61455

Contacts

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Mattoon/Charleston

Recruiting

Mattoon, Illinois, United States, 61938

Contacts

Principal Investigator:

Priyank P. Patel

Cancer Care Center of O'Fallon

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Principal Investigator:

Bryan A. Faller

Northwestern Medicine Oak Brook

Recruiting

Oak Brook, Illinois, United States, 60523

Contacts

Principal Investigator:

Sean Sachdev

Northwestern Medicine Orland Park

Recruiting

Orland Park, Illinois, United States, 60462

Contacts

Principal Investigator:

Sean Sachdev

Illinois CancerCare-Ottawa Clinic

Recruiting

Ottawa, Illinois, United States, 61350

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Pekin

Recruiting

Pekin, Illinois, United States, 61554

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peoria

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Recruiting

Peoria, Illinois, United States, 61615

Contacts

Principal Investigator:

Bryan A. Faller

OSF Saint Francis Medical Center

Recruiting

Peoria, Illinois, United States, 61637

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Peru

Recruiting

Peru, Illinois, United States, 61354

Contacts

Principal Investigator:

Bryan A. Faller

Illinois CancerCare-Princeton

Recruiting

Princeton, Illinois, United States, 61356

Contacts

Principal Investigator:

Bryan A. Faller

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

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Principal Investigator:

Priyank P. Patel

Northwestern Medicine Cancer Center Warrenville

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Principal Investigator:

Sean Sachdev

Illinois CancerCare - Washington

Recruiting

Washington, Illinois, United States, 61571

Contacts

Principal Investigator:

Bryan A. Faller

Mary Greeley Medical Center

Recruiting

Ames, Iowa, United States, 50010

Contacts

Site Public Contact

515-956-4132

Principal Investigator:

Joseph J. Merchant

McFarland Clinic - Ames

Recruiting

Ames, Iowa, United States, 50010

Contacts

Principal Investigator:

Joseph J. Merchant

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

Mercy Cancer Center-West Lakes

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Recruiting

Clive, Iowa, United States, 50325

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Seema Harichand-Herdt

Iowa Methodist Medical Center

Recruiting

Des Moines, Iowa, United States, 50309

Contacts

Site Public Contact

515-241-6727

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

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-241-3305

Principal Investigator:

Richard L. Deming

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

The Iowa Clinic PC

Recruiting

West Des Moines, Iowa, United States, 50266

Contacts

Site Public Contact

515-875-9815

Principal Investigator:

Seema Harichand-Herdt

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Insija Ilyas Selene

The James Graham Brown Cancer Center at University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Site Public Contact

502-562-3429

Principal Investigator:

Scott R. Silva

UofL Health Medical Center Northeast

Recruiting

Louisville, Kentucky, United States, 40245

Contacts

Principal Investigator:

Scott R. Silva

University Medical Center New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Principal Investigator:

Rajasree P. Chowdry

Ochsner Medical Center Jefferson

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Principal Investigator:

Kyle Rose

Tufts Medical Center

Recruiting

Boston, Massachusetts, United States, 02111

Contacts

Principal Investigator:

Brett Diamond

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Site Public Contact

877-442-3324

Principal Investigator:

Kent W. Mouw

UMass Memorial Medical Center - University Campus

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Principal Investigator:

Kriti Mittal

Sanford Joe Lueken Cancer Center

Recruiting

Bemidji, Minnesota, United States, 56601

Contacts

Principal Investigator:

Daniel Almquist

Fairview Southdale Hospital

Recruiting

Edina, Minnesota, United States, 55435

Contacts

Principal Investigator:

David M. King

Abbott-Northwestern Hospital

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Principal Investigator:

David M. King

Park Nicollet Clinic - Saint Louis Park

Recruiting

Saint Louis Park, Minnesota, United States, 55416

Contacts

Principal Investigator:

David M. King

University of Mississippi Medical Center

Recruiting

Jackson, Mississippi, United States, 39216

Contacts

Site Public Contact

601-815-6700

Principal Investigator:

John C. Henegan

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

Billings Clinic Cancer Center

Recruiting

Billings, Montana, United States, 59101

Contacts

Principal Investigator:

John M. Schallenkamp

Benefis Sletten Cancer Institute

Recruiting

Great Falls, Montana, United States, 59405

Contacts

Principal Investigator:

John M. Schallenkamp

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, United States, 03756

Contacts

Principal Investigator:

James B. Yu

Jefferson Cherry Hill Hospital

Recruiting

Cherry Hill, New Jersey, United States, 08002

Contacts

Principal Investigator:

Joseph M. Caster

Hunterdon Medical Center

Recruiting

Flemington, New Jersey, United States, 08822

Contacts

Site Public Contact

908-237-2330

Principal Investigator:

Myron E. Bednar

Jersey City Medical Center

Recruiting

Jersey City, New Jersey, United States, 07302

Contacts

Principal Investigator:

Lara Hathout

Cooperman Barnabas Medical Center

Recruiting

Livingston, New Jersey, United States, 07039

Contacts

Site Public Contact

973-322-5200

Principal Investigator:

Lara Hathout

Rutgers Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08903

Contacts

Site Public Contact

732-235-7356

Principal Investigator:

Lara Hathout

Sidney Kimmel Cancer Center Washington Township

Recruiting

Sewell, New Jersey, United States, 08080

Contacts

Principal Investigator:

Joseph M. Caster

The New York Hospital Medical Center of Queens

Recruiting

Flushing, New York, United States, 11355

Contacts

Principal Investigator:

Leen Khoury

NYP/Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-746-1848

Principal Investigator:

Rohit Jain

Stony Brook University Medical Center

Recruiting

Stony Brook, New York, United States, 11794

Contacts

Site Public Contact

800-862-2215

Principal Investigator:

Judy Huang

Sanford Broadway Medical Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

Sanford Roger Maris Cancer Center

Recruiting

Fargo, North Dakota, United States, 58122

Contacts

Principal Investigator:

Daniel Almquist

University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Bailey A. Nelson

MetroHealth Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Contacts

Principal Investigator:

Roger Ove

University of Cincinnati Cancer Center-West Chester

Recruiting

West Chester, Ohio, United States, 45069

Contacts

Principal Investigator:

Bailey A. Nelson

University of Oklahoma Health Sciences Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Kelly L. Stratton

University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Ronac Mamtani

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Principal Investigator:

Joseph M. Caster

Asplundh Cancer Pavilion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Principal Investigator:

Joseph M. Caster

Sanford Cancer Center Oncology Clinic

Recruiting

Sioux Falls, South Dakota, United States, 57104

Contacts

Principal Investigator:

Daniel Almquist

Sanford USD Medical Center - Sioux Falls

Recruiting

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

Contacts

Principal Investigator:

Daniel Almquist

The West Clinic - Wolf River

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Principal Investigator:

Daniel A. Vaena

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Principal Investigator:

Suzanne M. Cole

UT Southwestern Simmons Cancer Center - RedBird

Recruiting

Dallas, Texas, United States, 75237

Contacts

Principal Investigator:

Suzanne M. Cole

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Suzanne M. Cole

UT Southwestern/Simmons Cancer Center-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Suzanne M. Cole

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Site Public Contact

713-798-1354burton@bcm.edu

Principal Investigator:

Daniel A. Hamstra

UT Southwestern Clinical Center at Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Contacts

Principal Investigator:

Suzanne M. Cole

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Chul S. Ha

Scott and White Memorial Hospital

Recruiting

Temple, Texas, United States, 76508

Contacts

Site Public Contact

254-724-5407

Principal Investigator:

Lucas Wong

Huntsman Cancer Institute/University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Principal Investigator:

Bogdana Schmidt

Dartmouth Cancer Center - North

Recruiting

Saint Johnsbury, Vermont, United States, 05819

Contacts

Principal Investigator:

James B. Yu

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Site Public Contact

ctoclinops@vcu.edu

Principal Investigator:

Alfredo I. Urdaneta

VCU Massey Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Alfredo I. Urdaneta

Fred Hutchinson Cancer Center

Recruiting

Seattle, Washington, United States, 98109

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Omar Y. Mian

Swedish Medical Center-First Hill

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

Charles W. Drescher

University of Washington Medical Center - Montlake

Recruiting

Seattle, Washington, United States, 98195

Contacts

Site Public Contact

800-804-8824

Principal Investigator:

Omar Y. Mian

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Principal Investigator:

Muhammad Mohsin Fareed

Camden Clark Medical Center

Recruiting

Parkersburg, West Virginia, United States, 26101

Contacts

Principal Investigator:

Muhammad Mohsin Fareed

Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton

Recruiting

Appleton, Wisconsin, United States, 54915

Contacts

Site Public Contact

AWRI.inquiry@ascension.org

Principal Investigator:

Francis J. Cuevas

Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield

Recruiting

Brookfield, Wisconsin, United States, 53045

Contacts

Site Public Contact

AWRI.Inquiry@Ascension.org

Principal Investigator:

Francis J. Cuevas

Ascension Calumet Hospital-Chilton

Recruiting

Chilton, Wisconsin, United States, 53014

Contacts

Site Public Contact

AWRI.inquiry@ascension.org

Principal Investigator:

Francis J. Cuevas

Reiman Cancer Center-Ascension Wisconsin Health Center-Rawson

Recruiting

Franklin, Wisconsin, United States, 53132

Contacts

Site Public Contact

AWRI.Inquiry@Ascension.org

Principal Investigator:

Francis J. Cuevas

Saint Vincent Hospital Cancer Center Green Bay

Recruiting

Green Bay, Wisconsin, United States, 54301

Contacts

Principal Investigator:

Matthew L. Ryan

Saint Vincent Hospital Cancer Center at Saint Mary's

Recruiting

Green Bay, Wisconsin, United States, 54303

Contacts

Principal Investigator:

Matthew L. Ryan

Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon

Recruiting

Mequon, Wisconsin, United States, 53097

Contacts

Site Public Contact

AWRI.Inquiry@Ascension.org

Principal Investigator:

Francis J. Cuevas

Ascension Columbia Saint Mary's Hospital-Milwaukee Campus

Recruiting

Milwaukee, Wisconsin, United States, 53211

Contacts

Site Public Contact

AWRI.Inquiry@Ascension.org

Principal Investigator:

Francis J. Cuevas

Saint Vincent Hospital Cancer Center at Oconto Falls

Recruiting

Oconto Falls, Wisconsin, United States, 54154

Contacts

Principal Investigator:

Matthew L. Ryan

Ascension Northeast Wisconsin-Mercy Hospital-Oshkosh

Recruiting

Oshkosh, Wisconsin, United States, 54904

Contacts

Site Public Contact

AWRI.inquiry@ascension.org

Principal Investigator:

Francis J. Cuevas

Ascension All Saints Hospital-Spring Street-Racine

Recruiting

Racine, Wisconsin, United States, 53405

Contacts

Site Public Contact

AWRI.Inquiry@Ascension.org

Principal Investigator:

Francis J. Cuevas

Saint Vincent Hospital Cancer Center at Sheboygan

Recruiting

Sheboygan, Wisconsin, United States, 53081

Contacts

Principal Investigator:

Matthew L. Ryan

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Recruiting

Sturgeon Bay, Wisconsin, United States, 54235-1495

Contacts

Principal Investigator:

Matthew L. Ryan

Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa

Recruiting

Wauwatosa, Wisconsin, United States, 53226

Contacts

Site Public Contact

AWRI.Inquiry@Ascension.org

Principal Investigator:

Francis J. Cuevas

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 31, 2026

Last verified

Jul, 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 2026-08-31.