Recruiting
Phase 2

Pembrolizumab & Radiation

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06770582

Conditions

Non-Muscle Invasive Bladder Urothelial Carcinoma

Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma

Stage I Bladder Cancer AJCC v8

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Cisplatin

Computed Tomography

Fluorouracil

Gemcitabine

Study Details

Brief summary:

This phase II trial compares the use of pembrolizumab and radiation therapy to chemotherapy with cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C and radiation therapy for the treatment of non-muscle invasive bladder cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, gemcitabine, 5-fluorouracil or mitomycin-C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with radiation may kill more tumor cells than chemotherapy with radiation therapy in patients with non-muscle invasive bladder cancer.

Conditions

Non-Muscle Invasive Bladder Urothelial Carcinoma

Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma

Stage I Bladder Cancer AJCC v8

Study ID

NCT06770582

Start date

Jun 3, 2025

Status verified date

Jun, 2026

Completion date

Feb 1, 2032

Anticipated

Primary completion date

Feb 1, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Pathologically (histologically) proven diagnosis of T1 high-grade non-muscle invasive urothelial carcinoma of the bladder without radiographic evidence of regional nodal disease or metastatic disease (N0, M0) on CT, MRI, or positron emission tomography (PET)/CT scan who would otherwise be treated with cystectomy off-trial. Patients should have cystectomy recommended disease but do not need to be medically operable for a cystectomy to be eligible for the trial.

  • NOTE: Patients with nodal disease ≥ 1 cm on short-axis or with suspicious nodes that are PET-avid of any size are not eligible
  • High grade T1 disease history that must meet at least ONE of the three criteria below:

  • Histologically confirmed recurrence with high-grade T1 urothelial carcinoma (+/- focal carcinoma in situ \[CIS\]) in the bladder following initial transurethral resection of bladder tumor (TURBT) and at least one induction course of intravesical therapy. Adequate induction course is defined as ≥ 5 doses of intravesical Bacillus Calmette-Guerin (BCG) or intravesical chemotherapy when BCG is not available.
  • T1 with pathologic high-risk features (lymphovascular invasion \[LVI\] or variant histology of micropapillary, sarcomatoid, or plasmacytoid features) post initial TURBT. (No prior intravesical therapy required)
  • Persistent high-grade T1 urothelial carcinoma at repeat TURBT (+/- focal CIS) in the bladder. (No prior intravesical therapy required)
  • Restaging TURBT must be performed and must meet ALL of the following criteria below:

  • If there is absence of muscularis propria in the initial TURBT, there must be uninvolved muscularis propria in the restaging TURBT.
  • All grossly visible papillary tumors must be removed

  • Note: If the restaging TURBT is performed outside of the enrolling institution, an office cystoscopy should be performed by a Urologist who will be following the patient as part of the clinical trial
  • No pure squamous cell carcinoma or adenocarcinoma of the bladder
  • No neuroendocrine (small or large cell) features
  • No diffuse carcinoma in situ determined on cystoscopy and biopsy (i.e. extensive carcinoma in situ that is not just tumor-associated CIS in the opinion of the site investigator)
  • No prostatic urethral involvement
  • Age ≥ 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation or who is not postmenopausal
  • 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)
  • Adequate renal function defined as creatinine clearance (CrCL) of ≥ 30 mL/min by the Cockcroft-Gault formula, ≤ 1.5 × upper limit of normal (ULN) or creatinine levels > 1.5 × institutional ULN
  • Total bilirubin ≤ institutional upper limit of normal (ULN) (Not applicable to patients with known Gilbert's syndrome)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
  • All adverse events of their most recent therapy/intervention must have resolved to < grade 3 or returned to baseline prior to registration
  • No history of pelvic radiation therapy
  • No prior systemic chemotherapy or immunotherapy for urothelial carcinoma. Prior treatment with local intravesical therapy including BCG or chemotherapy is allowed
  • No prior treatment with anti-PD-1, anti PD-L1, anti PD-L2 or anti-CTLA4 antibody or any other antibody or drug targeting T-cell co-stimulation
  • No live vaccine administered within 30 days of registration. All non live vaccines (including the coronavirus disease \[COVID\] vaccine) are allowed at any time during the study. Timing should minimize confusion with drug-related toxicities where possible
  • Patients must have recovered from acute cardiac illness
  • New York Heart Association Functional Classification II or better (New York Heart Association \[NYHA\] Functional Classification III/IV are not eligible) (Note: 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.)
  • No active infection requiring IV antibiotics
  • No active autoimmune disease that required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
  • No history of idiopathic pulmonary fibrosis, organizing pneumonia, (non-infectious) pneumonitis that required steroids or current pneumonitis
  • No history of allogeneic bone marrow transplant or prior solid organ transplant
  • No active tuberculosis
  • No evidence of hydronephrosis
  • No history of upper tract urothelial carcinoma within 24 months of registration
  • No patients with a prior diagnosis of prostate cancer who have not received definitive treatment for their prostate cancer (e.g. on active surveillance)
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • No glucocorticoids except physiologic doses are allowed. The use of doses of corticosteroids (defined as 10 mg prednisone or equivalent) is acceptable
  • No history of allergic reaction to the drug excipients

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm 1 (Chemotherapy and radiation)

Patients receive one of the following chemotherapy regimens per physicians choice: 1) cisplatin IV once per week for 4 weeks, 2) gemcitabine IV on days 1, 4, 8, 11, 15, 18, 22, and 25, or 3) mitomycin IV on day 1 and 5-fluorouracil IV continuously over 120 hours on days 1-5 and 16-20. Patients receiving cisplatin or gemcitabine continue chemotherapy for 6 weeks if they are receiving radiation according to the standard hypofractionated radiation schedule. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI and blood sample collection throughout the study. Patients may also undergo optional urine sample collection on study.

experimental: Arm 2 (Pembrolizumab and radiation)

Patients receive pembrolizumab IV over 25-40 minutes on day 1 of each cycle. Cycles repeat every 6 weeks for 9 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 1, patients also receive radiation therapy for 20, 32, or 36 treatments over 4-7 weeks. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients also undergo CT/MRI and blood sample collection throughout the study. Patients may also undergo optional urine sample collection on study.

Interventions

Biospecimen Collection

Undergo blood and urine sample collection

Cisplatin

Given IV

Computed Tomography

Undergo CT

Fluorouracil

Given IV

Gemcitabine

Given IV

Magnetic Resonance Imaging

Undergo MRI

Mitomycin

Given IV

Pembrolizumab

Given IV

Questionnaire Administration

Ancillary studies

Radiation Therapy

Undergo radiation therapy

Primary outcome measure

  • Bladder intact event-free survival (BIEFS) [ Time Frame: Up to 5 years ]
  • Global quality of life [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Locations

Highlands Oncology Group - Fayetteville

Recruiting

Fayetteville, Arkansas, United States, 72703

Contacts

Site Public Contact

479-872-8100research@hogonc.com

Principal Investigator:

Joseph T. Beck

Highlands Oncology Group - Rogers

Recruiting

Rogers, Arkansas, United States, 72758

Contacts

Site Public Contact

479-872-8130research@hogonc.com

Principal Investigator:

Joseph T. Beck

Highlands Oncology Group

Recruiting

Springdale, Arkansas, United States, 72762

Contacts

Site Public Contact

479-872-8130research@hogonc.com

Principal Investigator:

Joseph T. Beck

AIS Cancer Center at San Joaquin Community Hospital

Recruiting

Bakersfield, California, United States, 93301

Contacts

Site Public Contact

661-323-4673

Principal Investigator:

Luis Mariscal

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451uscnorrisinfo@med.usc.edu

Principal Investigator:

Lauren A. Lukas

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Site Public Contact

323-865-0451

Principal Investigator:

Lauren A. Lukas

Shaw Cancer Center

Recruiting

Edwards, Colorado, United States, 81632

Contacts

Site Public Contact

970-569-7429

Principal Investigator:

Erin Schwab

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

UF Health Cancer Institute - Gainesville

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Site Public Contact

352-273-8010

Principal Investigator:

Daniel V. Araujo

Mount Sinai Medical Center

Recruiting

Miami Beach, Florida, United States, 33140

Contacts

Site Public Contact

305-674-2625Yvonne.Enriquez@msmc.com

Principal Investigator:

Bruno R. Bastos

Grady Health System

Recruiting

Atlanta, Georgia, United States, 30303

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Kamran Salari

Emory Proton Therapy Center

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

404-251-2854allyson.anderson@emory.edu

Principal Investigator:

Kamran Salari

Emory University Hospital Midtown

Recruiting

Atlanta, Georgia, United States, 30308

Contacts

Site Public Contact

888-946-7447

Principal Investigator:

Kamran Salari

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Kamran Salari

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Kamran Salari

Rush MD Anderson Cancer Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Site Public Contact

312-226-2371Cancer_Studies@rush.edu

Principal Investigator:

Dian Wang

Carle at The Riverfront

Recruiting

Danville, Illinois, United States, 61832

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Daniel H. Barnett

Cancer Care Specialists of Illinois - Decatur

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

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

Principal Investigator:

Bryan A. Faller

Decatur Memorial Hospital

Recruiting

Decatur, Illinois, United States, 62526

Contacts

Site Public Contact

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

Principal Investigator:

Bryan A. Faller

Carle Physician Group-Effingham

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Daniel H. Barnett

Crossroads Cancer Center

Recruiting

Effingham, Illinois, United States, 62401

Contacts

Site Public Contact

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

Daniel H. Barnett

Carle BroMenn Medical Center

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Daniel H. Barnett

Carle Cancer Institute Normal

Recruiting

Normal, Illinois, United States, 61761

Contacts

Site Public Contact

800-446-5532Research@Carle.com

Principal Investigator:

Daniel H. Barnett

HSHS Saint Elizabeth's Hospital

Recruiting

O'Fallon, Illinois, United States, 62269

Contacts

Site Public Contact

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

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

Site Public Contact

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

Principal Investigator:

Bryan A. Faller

Carle Cancer Center

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Site Public Contact

800-446-5532Research@carle.com

Principal Investigator:

Daniel H. Barnett

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

Site Public Contact

515-239-4734ksoder@mcfarlandclinic.com

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

Broadlawns Medical Center

Recruiting

Des Moines, Iowa, United States, 50314

Contacts

Site Public Contact

515-282-2200

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 Healthcare Mission Cancer and Blood - Pella

Recruiting

Pella, Iowa, United States, 50219

Contacts

Site Public Contact

515-282-2921trials@missioncancer.com

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 Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Eugene K. Lee

University of Kansas Cancer Center-Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Eugene K. Lee

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:

Eugene K. Lee

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:

Eugene K. Lee

Louisiana Hematology Oncology Associates LLC

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Site Public Contact

225-215-1353clinicalresearch@marybird.com

Principal Investigator:

Scott E. Delacroix

Mary Bird Perkins Cancer Center

Recruiting

Baton Rouge, Louisiana, United States, 70809

Contacts

Site Public Contact

225-215-1353clinicalresearch@marybird.com

Principal Investigator:

Scott E. Delacroix

Mary Bird Perkins Cancer Center - Gonzales

Recruiting

Gonzales, Louisiana, United States, 70737

Contacts

Site Public Contact

225-215-1353clinicalresearch@marybird.com

Principal Investigator:

Scott E. Delacroix

Mary Bird Perkins Cancer Center - Metairie

Recruiting

Metairie, Louisiana, United States, 70002

Contacts

Site Public Contact

504-584-6990

Principal Investigator:

Scott E. Delacroix

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Site Public Contact

877-726-5130

Principal Investigator:

Sophia C. Kamran

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Recruiting

Ann Arbor, Michigan, United States, 48106

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Samir Narayan

Trinity Health Medical Center - Brighton

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Samir Narayan

Trinity Health Medical Center - Canton

Recruiting

Canton, Michigan, United States, 48188

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Samir Narayan

Chelsea Hospital

Recruiting

Chelsea, Michigan, United States, 48118

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Samir Narayan

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Site Public Contact

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

Principal Investigator:

Samir Narayan

Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, United States, 48154

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Samir Narayan

Michigan Healthcare Professionals Pontiac

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

248-858-6215Emily.Crofts@trinity-health.org

Principal Investigator:

Samir Narayan

Trinity Health Saint Joseph Mercy Oakland Hospital

Recruiting

Pontiac, Michigan, United States, 48341

Contacts

Site Public Contact

734-712-7251MCRCwebsitecontactform@stjoeshealth.org

Principal Investigator:

Samir Narayan

University of Michigan Health - West

Recruiting

Wyoming, Michigan, United States, 49519

Contacts

Site Public Contact

616-391-1230crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

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 - Deer River Clinic

Recruiting

Deer River, Minnesota, United States, 56636

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Essentia Health Cancer Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Essentia Health Saint Mary's Medical Center

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Miller-Dwan Hospital

Recruiting

Duluth, Minnesota, United States, 55805

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Essentia Health Hibbing Clinic

Recruiting

Hibbing, Minnesota, United States, 55746

Contacts

Site Public Contact

218-786-3308

Principal Investigator:

Bret E. Friday

Essentia Health Sandstone

Recruiting

Sandstone, Minnesota, United States, 55072

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Essentia Health Virginia Clinic

Recruiting

Virginia, Minnesota, United States, 55792

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Saint Francis Medical Center

Recruiting

Cape Girardeau, Missouri, United States, 63703

Contacts

Site Public Contact

573-334-2230sfmc@sfmc.net

Principal Investigator:

Bryan A. Faller

Parkland Health Center - Farmington

Recruiting

Farmington, Missouri, United States, 63640

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

University of Kansas Cancer Center - Briarcliff

Recruiting

Kansas City, Missouri, United States, 64116

Contacts

Site Public Contact

913-588-3671

Principal Investigator:

Eugene K. Lee

University of Kansas Cancer Center - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Eugene K. Lee

University of Kansas Cancer Center - Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Site Public Contact

913-588-3671KUCC_Navigation@kumc.edu

Principal Investigator:

Eugene K. Lee

Lake Regional Hospital

Recruiting

Osage Beach, Missouri, United States, 65065

Contacts

Site Public Contact

573-302-2768clinicaltrials@lakeregional.com

Principal Investigator:

Jay W. Carlson

Sainte Genevieve County Memorial Hospital

Recruiting

Sainte Genevieve, Missouri, United States, 63670

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital South

Recruiting

St Louis, Missouri, United States, 63128

Contacts

Site Public Contact

314-525-6042Danielle.Werle@mercy.net

Principal Investigator:

Jay W. Carlson

Missouri Baptist Medical Center

Recruiting

St Louis, Missouri, United States, 63131

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Mercy Hospital Saint Louis

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Site Public Contact

314-251-7066

Principal Investigator:

Jay W. Carlson

Missouri Baptist Sullivan Hospital

Recruiting

Sullivan, Missouri, United States, 63080

Contacts

Site Public Contact

314-996-5569

Principal Investigator:

Bryan A. Faller

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Justin M. Haseltine

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:

Mary E. Westerman

Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States, 43214

Contacts

Site Public Contact

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

Principal Investigator:

Michael Siedow

Grant Medical Center

Recruiting

Columbus, Ohio, United States, 43215

Contacts

Site Public Contact

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

Principal Investigator:

Michael Siedow

Doctors Hospital

Recruiting

Columbus, Ohio, United States, 43228

Contacts

Site Public Contact

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

Principal Investigator:

Michael Siedow

Dublin Methodist Hospital

Recruiting

Dublin, Ohio, United States, 43016

Contacts

Site Public Contact

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

Principal Investigator:

Michael Siedow

OhioHealth Mansfield Hospital

Recruiting

Mansfield, Ohio, United States, 44903

Contacts

Site Public Contact

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

Principal Investigator:

Michael Siedow

OhioHealth Marion General Hospital

Recruiting

Marion, Ohio, United States, 43302

Contacts

Site Public Contact

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

Principal Investigator:

Michael Siedow

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:

Tyler Gunter

Christiana Care Health System-Concord Health Center

Recruiting

Chadds Ford, Pennsylvania, United States, 19317

Contacts

Site Public Contact

302-623-4450lbarone@christianacare.org

Principal Investigator:

Gregory A. Masters

Geisinger Medical Center

Recruiting

Danville, Pennsylvania, United States, 17822

Contacts

Site Public Contact

570-271-5251cancerresearch@geisinger.edu

Principal Investigator:

Heath B. Mackley

Geisinger Cancer Center Dickson City

Recruiting

Dickson City, Pennsylvania, United States, 18519

Contacts

Site Public Contact

877-204-6081cancerresearch@geisinger.edu

Principal Investigator:

Heath B. Mackley

UPMC Hillman Cancer Center Erie

Recruiting

Erie, Pennsylvania, United States, 16505

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Adam Olson

UPMC Cancer Center at UPMC Horizon

Recruiting

Farrell, Pennsylvania, United States, 16121

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Adam Olson

UPMC Cancer Centers - Arnold Palmer Pavilion

Recruiting

Greensburg, Pennsylvania, United States, 15601

Contacts

Site Public Contact

724-838-1900

Principal Investigator:

Adam Olson

Penn State Milton S Hershey Medical Center

Recruiting

Hershey, Pennsylvania, United States, 17033-0850

Contacts

Site Public Contact

717-531-3779CTO@hmc.psu.edu

Principal Investigator:

Hyma Polimera

Geisinger Medical Oncology-Lewisburg

Recruiting

Lewisburg, Pennsylvania, United States, 17837

Contacts

Site Public Contact

570-523-9200cancerresearch@geisinger.edu

Principal Investigator:

Heath B. Mackley

UPMC Cancer Center - Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Adam Olson

UPMC Hillman Cancer Center - Monroeville

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Site Public Contact

412-864-7716ClinicalResearchServices@upmc.edu

Principal Investigator:

Adam Olson

UPMC Hillman Cancer Center - New Castle

Recruiting

New Castle, Pennsylvania, United States, 16105

Contacts

Site Public Contact

412-389-5208haneydl@upmc.edu

Principal Investigator:

Adam Olson

UPMC-Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Site Public Contact

412-647-2811

Principal Investigator:

Adam Olson

UPMC-Saint Margaret

Recruiting

Pittsburgh, Pennsylvania, United States, 15215

Contacts

Site Public Contact

412-784-4900

Principal Investigator:

Adam Olson

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-647-8073

Principal Investigator:

Adam Olson

UPMC-Shadyside Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Site Public Contact

412-621-2334

Principal Investigator:

Adam Olson

UPMC-Passavant Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15237

Contacts

Site Public Contact

412-367-6454

Principal Investigator:

Adam Olson

UPMC Cancer Center at UPMC Northwest

Recruiting

Seneca, Pennsylvania, United States, 16346

Contacts

Site Public Contact

814-676-7900

Principal Investigator:

Adam Olson

UPMC Cancer Center-Washington

Recruiting

Washington, Pennsylvania, United States, 15301

Contacts

Site Public Contact

412-339-5294Roster@nrgoncology.org

Principal Investigator:

Adam Olson

UPMC Washington Hospital Radiation Oncology

Recruiting

Washington, Pennsylvania, United States, 15301

Contacts

Site Public Contact

724-223-3788cancer@washingtonhospital.org

Principal Investigator:

Adam Olson

Geisinger Wyoming Valley/Henry Cancer Center

Recruiting

Wilkes-Barre, Pennsylvania, United States, 18711

Contacts

Site Public Contact

570-271-5251HemonCCTrials@geisinger.edu

Principal Investigator:

Heath B. Mackley

Central Vermont Medical Center/National Life Cancer Treatment

Recruiting

Berlin Corners, Vermont, United States, 05602

Contacts

Site Public Contact

802-225-5400

Principal Investigator:

Alexander P. Lukez

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Site Public Contact

802-656-4101rpo@uvm.edu

Principal Investigator:

Alexander P. Lukez

University of Vermont and State Agricultural College

Recruiting

Burlington, Vermont, United States, 05405

Contacts

Site Public Contact

802-656-8990rpo@uvm.edu

Principal Investigator:

Alexander P. Lukez

University of Virginia Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Site Public Contact

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

Principal Investigator:

Christopher Luminais

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 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 Comprehensive Cancer Center

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Site Public Contact

804-628-6430CTOclinops@vcu.edu

Principal Investigator:

Alfredo I. Urdaneta

VCU Community Memorial Health Center

Recruiting

South Hill, Virginia, United States, 23970

Contacts

Site Public Contact

nemer.elmouallem@vcuhealth.org

Principal Investigator:

Alfredo I. Urdaneta

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Site Public Contact

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

Principal Investigator:

Joanna A. Kolodney

Duluth Clinic Ashland

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Northwest Wisconsin Cancer Center

Recruiting

Ashland, Wisconsin, United States, 54806

Contacts

Site Public Contact

218-786-3308CancerTrials@EssentiaHealth.org

Principal Investigator:

Bret E. Friday

Marshfield Medical Center - Weston

Recruiting

Weston, Wisconsin, United States, 54476

Contacts

Site Public Contact

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

Principal Investigator:

Bevan Ly

The Research Institute of the McGill University Health Centre (MUHC)

Recruiting

Montreal, Quebec, Canada, H3H 2R9

Contacts

Site Public Contact

514-934-1934evelyn.ortega@muhc.mcgill.ca

Principal Investigator:

Fabio L. Cury

CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)

Recruiting

Québec, Quebec, Canada, G1R 2J6

Contacts

Site Public Contact

rechclinique@crchuq.ulaval.ca

Principal Investigator:

Eric Vigneault

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Aug 24, 2026

Last verified

Jun, 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 2026-08-24.