Immunotherapy vs chemo: new hope for bladder cancer patients?
NCT ID NCT06770582
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 21 times
Summary
This phase II trial compares two treatments for high-grade T1 bladder cancer that hasn't spread. One group gets the immunotherapy drug pembrolizumab plus radiation, while the other gets standard chemotherapy (cisplatin, gemcitabine, 5-fluorouracil, or mitomycin-C) plus radiation. The goal is to see which combo better prevents cancer from returning or spreading, and helps patients keep their bladder. The study plans to enroll 160 adults whose cancer would normally require bladder removal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pembrolizumab (immunotherapy drug)
- What this could lead to
- If it works, this could offer a less toxic, more effective treatment option for high-grade bladder cancer, helping patients avoid bladder removal surgery.
- What could go wrong
- This is a phase II trial with only 160 participants, so results are preliminary. The immunotherapy may not be more effective than standard chemo, and could cause immune-related side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Feb 2032
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Get notified about this study
Sign up to get updates when this study changes or when new studies for Non-muscle invasive bladder urothelial carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
135 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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AIS Cancer Center at San Joaquin Community Hospital
RECRUITINGBakersfield, California, 93301, United States
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Bon Secours Cancer Institute at Reynolds Crossing
RECRUITINGRichmond, Virginia, 23230, United States
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Bon Secours Memorial Regional Medical Center
RECRUITINGMechanicsville, Virginia, 23116, United States
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Bon Secours Saint Francis Medical Center
RECRUITINGMidlothian, Virginia, 23114, United States
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Bon Secours Saint Mary's Hospital
RECRUITINGRichmond, Virginia, 23226, United States
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Broadlawns Medical Center
RECRUITINGDes Moines, Iowa, 50314, United States
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Bronson Methodist Hospital
RECRUITINGKalamazoo, Michigan, 49007, United States
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CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
RECRUITINGQuébec, Quebec, G1R 2J6, Canada
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Cancer Care Specialists of Illinois - Decatur
RECRUITINGDecatur, Illinois, 62526, United States
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Carle BroMenn Medical Center
RECRUITINGNormal, Illinois, 61761, United States
Contact Email: •••••@•••••
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Carle Cancer Center
RECRUITINGUrbana, Illinois, 61801, United States
Contact Email: •••••@•••••
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Carle Cancer Institute Normal
RECRUITINGNormal, Illinois, 61761, United States
Contact Email: •••••@•••••
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Carle Physician Group-Effingham
RECRUITINGEffingham, Illinois, 62401, United States
Contact Email: •••••@•••••
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Carle Physician Group-Mattoon/Charleston
RECRUITINGMattoon, Illinois, 61938, United States
Contact Email: •••••@•••••
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Carle at The Riverfront
RECRUITINGDanville, Illinois, 61832, United States
Contact Email: •••••@•••••
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Central Vermont Medical Center/National Life Cancer Treatment
RECRUITINGBerlin Corners, Vermont, 05602, United States
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Chelsea Hospital
RECRUITINGChelsea, Michigan, 48118, United States
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Christiana Care Health System-Concord Health Center
RECRUITINGChadds Ford, Pennsylvania, 19317, United States
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Crossroads Cancer Center
RECRUITINGEffingham, Illinois, 62401, United States
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Decatur Memorial Hospital
RECRUITINGDecatur, Illinois, 62526, United States
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Doctors Hospital
RECRUITINGColumbus, Ohio, 43228, United States
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Dublin Methodist Hospital
RECRUITINGDublin, Ohio, 43016, United States
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Duluth Clinic Ashland
RECRUITINGAshland, Wisconsin, 54806, United States
Contact Email: •••••@•••••
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Emory Proton Therapy Center
RECRUITINGAtlanta, Georgia, 30308, United States
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Emory Saint Joseph's Hospital
RECRUITINGAtlanta, Georgia, 30342, United States
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Emory University Hospital Midtown
RECRUITINGAtlanta, Georgia, 30308, United States
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Emory University Hospital/Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
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Essentia Health - Deer River Clinic
RECRUITINGDeer River, Minnesota, 56636, United States
Contact Email: •••••@•••••
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Essentia Health Cancer Center
RECRUITINGDuluth, Minnesota, 55805, United States
Contact Email: •••••@•••••
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Essentia Health Hibbing Clinic
RECRUITINGHibbing, Minnesota, 55746, United States
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Essentia Health Saint Joseph's Medical Center
RECRUITINGBrainerd, Minnesota, 56401, United States
Contact Email: •••••@•••••
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Essentia Health Saint Mary's Medical Center
RECRUITINGDuluth, Minnesota, 55805, United States
Contact Email: •••••@•••••
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Essentia Health Sandstone
RECRUITINGSandstone, Minnesota, 55072, United States
Contact Email: •••••@•••••
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Essentia Health Virginia Clinic
RECRUITINGVirginia, Minnesota, 55792, United States
Contact Email: •••••@•••••
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Geisinger Cancer Center Dickson City
RECRUITINGDickson City, Pennsylvania, 18519, United States
Contact Email: •••••@•••••
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Geisinger Medical Center
RECRUITINGDanville, Pennsylvania, 17822, United States
Contact Email: •••••@•••••
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Geisinger Medical Oncology-Lewisburg
RECRUITINGLewisburg, Pennsylvania, 17837, United States
Contact Email: •••••@•••••
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Geisinger Wyoming Valley/Henry Cancer Center
RECRUITINGWilkes-Barre, Pennsylvania, 18711, United States
Contact Email: •••••@•••••
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Grady Health System
RECRUITINGAtlanta, Georgia, 30303, United States
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Grant Medical Center
RECRUITINGColumbus, Ohio, 43215, United States
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HSHS Saint Elizabeth's Hospital
RECRUITINGO'Fallon, Illinois, 62269, United States
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Helen F Graham Cancer Center
RECRUITINGNewark, Delaware, 19713, United States
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Highlands Oncology Group
RECRUITINGSpringdale, Arkansas, 72762, United States
Contact Email: •••••@•••••
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Highlands Oncology Group - Fayetteville
RECRUITINGFayetteville, Arkansas, 72703, United States
Contact Email: •••••@•••••
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Highlands Oncology Group - Rogers
RECRUITINGRogers, Arkansas, 72758, United States
Contact Email: •••••@•••••
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Iowa Methodist Medical Center
RECRUITINGDes Moines, Iowa, 50309, United States
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Lake Regional Hospital
RECRUITINGOsage Beach, Missouri, 65065, United States
Contact Email: •••••@•••••
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Los Angeles General Medical Center
RECRUITINGLos Angeles, California, 90033, United States
Contact Email: •••••@•••••
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Louisiana Hematology Oncology Associates LLC
RECRUITINGBaton Rouge, Louisiana, 70809, United States
Contact Email: •••••@•••••
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Marshfield Medical Center - Weston
RECRUITINGWeston, Wisconsin, 54476, United States
Contact Email: •••••@•••••
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Mary Bird Perkins Cancer Center
RECRUITINGBaton Rouge, Louisiana, 70809, United States
Contact Email: •••••@•••••
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Mary Bird Perkins Cancer Center - Gonzales
RECRUITINGGonzales, Louisiana, 70737, United States
Contact Email: •••••@•••••
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Mary Bird Perkins Cancer Center - Metairie
RECRUITINGMetairie, Louisiana, 70002, United States
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Mary Greeley Medical Center
RECRUITINGAmes, Iowa, 50010, United States
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Massachusetts General Hospital Cancer Center
RECRUITINGBoston, Massachusetts, 02114, United States
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McFarland Clinic - Ames
RECRUITINGAmes, Iowa, 50010, United States
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Medical Oncology Hematology Consultants PA
RECRUITINGNewark, Delaware, 19713, United States
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Memorial Sloan Kettering Basking Ridge
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Commack
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Westchester
RECRUITINGHarrison, New York, 10604, United States
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Mercy Cancer Center-West Lakes
RECRUITINGClive, Iowa, 50325, United States
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Mercy Hospital Saint Louis
RECRUITINGSt Louis, Missouri, 63141, United States
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Mercy Hospital South
RECRUITINGSt Louis, Missouri, 63128, United States
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Mercy Medical Center - Des Moines
RECRUITINGDes Moines, Iowa, 50314, United States
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Michigan Healthcare Professionals Pontiac
RECRUITINGPontiac, Michigan, 48341, United States
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Miller-Dwan Hospital
RECRUITINGDuluth, Minnesota, 55805, United States
Contact Email: •••••@•••••
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Missouri Baptist Medical Center
RECRUITINGSt Louis, Missouri, 63131, United States
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Missouri Baptist Sullivan Hospital
RECRUITINGSullivan, Missouri, 63080, United States
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Mount Sinai Medical Center
RECRUITINGMiami Beach, Florida, 33140, United States
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Northwest Wisconsin Cancer Center
RECRUITINGAshland, Wisconsin, 54806, United States
Contact Email: •••••@•••••
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OhioHealth Mansfield Hospital
RECRUITINGMansfield, Ohio, 44903, United States
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OhioHealth Marion General Hospital
RECRUITINGMarion, Ohio, 43302, United States
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Parkland Health Center - Farmington
RECRUITINGFarmington, Missouri, 63640, United States
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Penn State Milton S Hershey Medical Center
RECRUITINGHershey, Pennsylvania, 17033-0850, United States
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Riverside Methodist Hospital
RECRUITINGColumbus, Ohio, 43214, United States
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Rush MD Anderson Cancer Center
RECRUITINGChicago, Illinois, 60612, United States
Contact Email: •••••@•••••
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Saint Francis Medical Center
RECRUITINGCape Girardeau, Missouri, 63703, United States
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Sainte Genevieve County Memorial Hospital
RECRUITINGSainte Genevieve, Missouri, 63670, United States
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Sanford Broadway Medical Center
ACTIVE_NOT_RECRUITINGFargo, North Dakota, 58122, United States
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Sanford Joe Lueken Cancer Center
ACTIVE_NOT_RECRUITINGBemidji, Minnesota, 56601, United States
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Sanford Roger Maris Cancer Center
ACTIVE_NOT_RECRUITINGFargo, North Dakota, 58122, United States
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Shaw Cancer Center
RECRUITINGEdwards, Colorado, 81632, United States
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Southern Illinois University School of Medicine
RECRUITINGSpringfield, Illinois, 62702, United States
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Springfield Clinic
RECRUITINGSpringfield, Illinois, 62702, United States
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Springfield Memorial Hospital
RECRUITINGSpringfield, Illinois, 62781, United States
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The Iowa Clinic PC
RECRUITINGWest Des Moines, Iowa, 50266, United States
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The Research Institute of the McGill University Health Centre (MUHC)
RECRUITINGMontreal, Quebec, H3H 2R9, Canada
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Trinity Health Medical Center - Brighton
RECRUITINGBrighton, Michigan, 48114, United States
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Trinity Health Medical Center - Canton
RECRUITINGCanton, Michigan, 48188, United States
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Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITINGAnn Arbor, Michigan, 48106, United States
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Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITINGPontiac, Michigan, 48341, United States
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Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITINGLivonia, Michigan, 48154, United States
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UC Irvine Health/Chao Family Comprehensive Cancer Center
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
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UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
RECRUITINGIrvine, California, 92612, United States
Contact Email: •••••@•••••
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UF Health Cancer Institute - Gainesville
RECRUITINGGainesville, Florida, 32610, United States
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UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITINGAnkeny, Iowa, 50023, United States
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UI Health Care Mission Cancer and Blood - Des Moines Clinic
RECRUITINGDes Moines, Iowa, 50309, United States
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UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITINGDes Moines, Iowa, 50314, United States
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UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITINGWaukee, Iowa, 50263, United States
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UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITINGClive, Iowa, 50325, United States
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UI Healthcare Mission Cancer and Blood - Pella
RECRUITINGPella, Iowa, 50219, United States
Contact Email: •••••@•••••
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UNC Lineberger Comprehensive Cancer Center
RECRUITINGChapel Hill, North Carolina, 27599, United States
Contact Email: •••••@•••••
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UPMC Cancer Center - Monroeville
RECRUITINGMonroeville, Pennsylvania, 15146, United States
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UPMC Cancer Center at UPMC Horizon
RECRUITINGFarrell, Pennsylvania, 16121, United States
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UPMC Cancer Center at UPMC Northwest
RECRUITINGSeneca, Pennsylvania, 16346, United States
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UPMC Cancer Center-Washington
RECRUITINGWashington, Pennsylvania, 15301, United States
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UPMC Cancer Centers - Arnold Palmer Pavilion
RECRUITINGGreensburg, Pennsylvania, 15601, United States
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UPMC Hillman Cancer Center
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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UPMC Hillman Cancer Center - Monroeville
RECRUITINGMonroeville, Pennsylvania, 15146, United States
Contact Email: •••••@•••••
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UPMC Hillman Cancer Center - New Castle
RECRUITINGNew Castle, Pennsylvania, 16105, United States
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UPMC Hillman Cancer Center Erie
RECRUITINGErie, Pennsylvania, 16505, United States
Contact Email: •••••@•••••
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UPMC Washington Hospital Radiation Oncology
RECRUITINGWashington, Pennsylvania, 15301, United States
Contact Email: •••••@•••••
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UPMC-Magee Womens Hospital
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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UPMC-Passavant Hospital
RECRUITINGPittsburgh, Pennsylvania, 15237, United States
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UPMC-Saint Margaret
RECRUITINGPittsburgh, Pennsylvania, 15215, United States
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UPMC-Shadyside Hospital
RECRUITINGPittsburgh, Pennsylvania, 15232, United States
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USC / Norris Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90033, United States
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University of Kansas Cancer Center
RECRUITINGKansas City, Kansas, 66160, United States
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University of Kansas Cancer Center - Briarcliff
RECRUITINGKansas City, Missouri, 64116, United States
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University of Kansas Cancer Center - Lee's Summit
RECRUITINGLee's Summit, Missouri, 64064, United States
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University of Kansas Cancer Center - North
RECRUITINGKansas City, Missouri, 64154, United States
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University of Kansas Cancer Center-Overland Park
RECRUITINGOverland Park, Kansas, 66210, United States
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University of Kansas Hospital-Indian Creek Campus
RECRUITINGOverland Park, Kansas, 66211, United States
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University of Kansas Hospital-Westwood Cancer Center
RECRUITINGWestwood, Kansas, 66205, United States
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University of Michigan Health - Sparrow Lansing
RECRUITINGLansing, Michigan, 48912, United States
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University of Michigan Health - West
RECRUITINGWyoming, Michigan, 49519, United States
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Vermont Medical Center
RECRUITINGBurlington, Vermont, 05401, United States
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University of Vermont and State Agricultural College
RECRUITINGBurlington, Vermont, 05405, United States
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University of Virginia Cancer Center
RECRUITINGCharlottesville, Virginia, 22908, United States
Contact Email: •••••@•••••
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VCU Community Memorial Health Center
RECRUITINGSouth Hill, Virginia, 23970, United States
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VCU Massey Comprehensive Cancer Center
RECRUITINGRichmond, Virginia, 23298, United States
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West Michigan Cancer Center
RECRUITINGKalamazoo, Michigan, 49007, United States
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West Virginia University Healthcare
RECRUITINGMorgantown, West Virginia, 26506, United States
Contact Email: •••••@•••••
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