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NCT06770582RecruitingPhase 2

Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial

Randomized Phase II Trial of Pembrolizumab and Radiation vs. Radiation and Concurrent Chemotherapy for High-Grade T1 Bladder Cancer (PARRC Trial)

Source: ClinicalTrials.gov · Last updated 19 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
160 (estimated)
First submitted
9 Jan 2025
Start date
3 Jun 2025
Primary completion date
1 Feb 2032
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT06770582

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 160
  • From 3 Jun 2025 to the primary completion date, 1 Feb 2032
  • 147 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (147)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Research Institute of the McGill University Health Centre (MUHC)
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MontrealCanadaRecruiting
CHU de Quebec-L'Hotel-Dieu de Quebec (HDQ)
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QuébecCanadaSuspended
McFarland Clinic - Ames
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AmesUnited StatesRecruiting
Mary Greeley Medical Center
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AmesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Ankeny Clinic
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AnkenyUnited StatesRecruiting
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann ArborUnited StatesRecruiting
Ascension Northeast Wisconsin-Saint Elizabeth Cancer Center-Appleton
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AppletonUnited StatesRecruiting
Duluth Clinic Ashland
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AshlandUnited StatesRecruiting
Northwest Wisconsin Cancer Center
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AshlandUnited StatesRecruiting
Grady Health System
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AtlantaUnited StatesRecruiting
Emory Saint Joseph's Hospital
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AtlantaUnited StatesRecruiting
Emory University Hospital Midtown
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AtlantaUnited StatesRecruiting
Emory University Hospital/Winship Cancer Institute
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AtlantaUnited StatesRecruiting
Emory Proton Therapy Center
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AtlantaUnited StatesRecruiting
Mount Sinai Comprehensive Cancer Center at Aventura
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AventuraUnited StatesRecruiting
AIS Cancer Center at San Joaquin Community Hospital
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BakersfieldUnited StatesRecruiting
Memorial Sloan Kettering Basking Ridge
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Basking RidgeUnited StatesRecruiting
Mary Bird Perkins Cancer Center
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Baton RougeUnited StatesRecruiting
Louisiana Hematology Oncology Associates LLC
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Baton RougeUnited StatesRecruiting
Sanford Joe Lueken Cancer Center
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BemidjiUnited StatesActive, not recruiting
Central Vermont Medical Center/National Life Cancer Treatment
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Berlin CornersUnited StatesRecruiting
Massachusetts General Hospital Cancer Center
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BostonUnited StatesRecruiting
Essentia Health Saint Joseph's Medical Center
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BrainerdUnited StatesRecruiting
Trinity Health Medical Center - Brighton
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BrightonUnited StatesRecruiting
Ascension Southeast Wisconsin Hospital-Elmbrook Campus-Brookfield
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BrookfieldUnited StatesRecruiting
University of Vermont and State Agricultural College
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BurlingtonUnited StatesRecruiting
University of Vermont Medical Center
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BurlingtonUnited StatesRecruiting
Trinity Health Medical Center - Canton
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CantonUnited StatesRecruiting
Saint Francis Medical Center
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Cape GirardeauUnited StatesRecruiting
Christiana Care Health System-Concord Health Center
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Chadds FordUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesRecruiting
University of Virginia Cancer Center
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CharlottesvilleUnited StatesRecruiting
Chelsea Hospital
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ChelseaUnited StatesRecruiting
Rush MD Anderson Cancer Center
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ChicagoUnited StatesRecruiting
Ascension Calumet Hospital-Chilton
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ChiltonUnited StatesRecruiting
Mercy Cancer Center-West Lakes
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CliveUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
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CliveUnited StatesRecruiting
Riverside Methodist Hospital
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ColumbusUnited StatesRecruiting
Doctors Hospital
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ColumbusUnited StatesRecruiting
Grant Medical Center
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ColumbusUnited StatesRecruiting
Memorial Sloan Kettering Commack
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CommackUnited StatesRecruiting
Carle at The Riverfront
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DanvilleUnited StatesRecruiting
Geisinger Medical Center
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DanvilleUnited StatesRecruiting
Decatur Memorial Hospital
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DecaturUnited StatesRecruiting
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesRecruiting
Essentia Health - Deer River Clinic
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Deer RiverUnited StatesRecruiting
Iowa Methodist Medical Center
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Des MoinesUnited StatesRecruiting
Broadlawns Medical Center
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Laurel Clinic
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Des MoinesUnited StatesRecruiting
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Des Moines Clinic
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Des MoinesUnited StatesRecruiting
Geisinger Cancer Center Dickson City
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Dickson CityUnited StatesRecruiting
Dublin Methodist Hospital
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DublinUnited StatesRecruiting
Essentia Health Saint Mary's Medical Center
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DuluthUnited StatesRecruiting
Miller-Dwan Hospital
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DuluthUnited StatesRecruiting
Essentia Health Cancer Center
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DuluthUnited StatesRecruiting
Shaw Cancer Center
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EdwardsUnited StatesRecruiting
Carle Physician Group-Effingham
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EffinghamUnited StatesRecruiting
Crossroads Cancer Center
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EffinghamUnited StatesRecruiting
UPMC Hillman Cancer Center Erie
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ErieUnited StatesRecruiting
Sanford Broadway Medical Center
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FargoUnited StatesActive, not recruiting
Sanford Roger Maris Cancer Center
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FargoUnited StatesActive, not recruiting
Parkland Health Center - Farmington
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FarmingtonUnited StatesRecruiting
UPMC Cancer Center at UPMC Horizon
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FarrellUnited StatesRecruiting
Highlands Oncology Group - Fayetteville
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FayettevilleUnited StatesRecruiting
UF Health Cancer Institute - Gainesville
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GainesvilleUnited StatesRecruiting
Mary Bird Perkins Cancer Center - Gonzales
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GonzalesUnited StatesRecruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
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GreensburgUnited StatesRecruiting
Memorial Sloan Kettering Westchester
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HarrisonUnited StatesRecruiting
Penn State Milton S. Hershey Medical Center
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HersheyUnited StatesRecruiting
Essentia Health Hibbing Clinic
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HibbingUnited StatesRecruiting
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
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IrvineUnited StatesRecruiting
Bronson Methodist Hospital
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KalamazooUnited StatesRecruiting
West Michigan Cancer Center
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KalamazooUnited StatesRecruiting
University of Kansas Cancer Center - North
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center - Briarcliff
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Kansas CityUnited StatesRecruiting
University of Kansas Cancer Center
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Kansas CityUnited StatesRecruiting
University of Michigan Health - Sparrow Lansing
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LansingUnited StatesRecruiting
University of Kansas Cancer Center - Lee's Summit
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Lee's SummitUnited StatesRecruiting
Geisinger Medical Oncology-Lewisburg
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LewisburgUnited StatesRecruiting
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesRecruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesRecruiting
Los Angeles General Medical Center
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Los AngelesUnited StatesRecruiting
OhioHealth Mansfield Hospital
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MansfieldUnited StatesRecruiting
OhioHealth Marion General Hospital
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MarionUnited StatesRecruiting
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesRecruiting
Bon Secours Memorial Regional Medical Center
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MechanicsvilleUnited StatesRecruiting
Ascension Columbia Saint Mary's Hospital-Ozaukee Campus-Mequon
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MequonUnited StatesRecruiting
Mary Bird Perkins Cancer Center - Metairie
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MetairieUnited StatesRecruiting
Mount Sinai Medical Center
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Miami BeachUnited StatesRecruiting
Memorial Sloan Kettering Monmouth
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MiddletownUnited StatesRecruiting
Bon Secours Saint Francis Medical Center
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MidlothianUnited StatesRecruiting
Ascension Columbia Saint Mary's Hospital-Milwaukee Campus
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MilwaukeeUnited StatesRecruiting
UPMC Cancer Center - Monroeville
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MonroevilleUnited StatesRecruiting
UPMC Hillman Cancer Center - Monroeville
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MonroevilleUnited StatesRecruiting
Memorial Sloan Kettering Bergen
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MontvaleUnited StatesRecruiting
West Virginia University Healthcare
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MorgantownUnited StatesRecruiting
Helen F Graham Cancer Center
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NewarkUnited StatesRecruiting
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesRecruiting
UPMC Hillman Cancer Center - New Castle
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New CastleUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
Carle Cancer Institute Normal
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NormalUnited StatesRecruiting
Carle BroMenn Medical Center
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NormalUnited StatesRecruiting
HSHS Saint Elizabeth's Hospital
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O'FallonUnited StatesRecruiting
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesRecruiting
UC Irvine Health- Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Lake Regional Hospital
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Osage BeachUnited StatesRecruiting
University of Kansas Hospital-Indian Creek Campus
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Overland ParkUnited StatesRecruiting
University of Kansas Cancer Center-Overland Park
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Overland ParkUnited StatesRecruiting
UI Healthcare Mission Cancer and Blood - Pella
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PellaUnited StatesRecruiting
UPMC-Saint Margaret
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PittsburghUnited StatesRecruiting
UPMC-Shadyside Hospital
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PittsburghUnited StatesRecruiting
UPMC Hillman Cancer Center
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PittsburghUnited StatesRecruiting
UPMC-Passavant Hospital
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PittsburghUnited StatesRecruiting
UPMC-Magee Womens Hospital
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PittsburghUnited StatesRecruiting
Michigan Healthcare Professionals Pontiac
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PontiacUnited StatesRecruiting
Trinity Health Saint Joseph Mercy Oakland Hospital
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PontiacUnited StatesRecruiting
Ascension All Saints Hospital-Spring Street-Racine
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RacineUnited StatesRecruiting
Bon Secours Saint Mary's Hospital
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RichmondUnited StatesRecruiting
Bon Secours Cancer Institute at Reynolds Crossing
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RichmondUnited StatesRecruiting
VCU Massey Comprehensive Cancer Center
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RichmondUnited StatesRecruiting
Highlands Oncology Group - Rogers
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RogersUnited StatesRecruiting
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesRecruiting
Essentia Health Sandstone
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SandstoneUnited StatesRecruiting
UPMC Cancer Center at UPMC Northwest
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SenecaUnited StatesRecruiting
VCU Community Memorial Health Center
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South HillUnited StatesRecruiting
Highlands Oncology Group
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SpringdaleUnited StatesRecruiting
Springfield Clinic
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SpringfieldUnited StatesRecruiting
Southern Illinois University School of Medicine
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SpringfieldUnited StatesRecruiting
Springfield Memorial Hospital
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SpringfieldUnited StatesRecruiting
Missouri Baptist Medical Center
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St LouisUnited StatesRecruiting
Mercy Hospital South
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St LouisUnited StatesRecruiting
Mercy Hospital Saint Louis
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St LouisUnited StatesRecruiting
Missouri Baptist Sullivan Hospital
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SullivanUnited StatesRecruiting
Banner University Medical Center - Tucson
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TucsonUnited StatesRecruiting
Memorial Sloan Kettering Nassau
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UniondaleUnited StatesRecruiting
Carle Cancer Center
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UrbanaUnited StatesRecruiting
Essentia Health Virginia Clinic
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VirginiaUnited StatesRecruiting
UPMC Washington Hospital Radiation Oncology
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WashingtonUnited StatesRecruiting
UPMC Cancer Center-Washington
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WashingtonUnited StatesRecruiting
UI Health Care Mission Cancer and Blood - Waukee Clinic
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WaukeeUnited StatesRecruiting
Ascension Southeast Wisconsin Hospital-Mayfair Road-Wauwatosa
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WauwatosaUnited StatesRecruiting
The Iowa Clinic PC
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West Des MoinesUnited StatesRecruiting
Marshfield Medical Center - Weston
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WestonUnited StatesRecruiting
University of Kansas Hospital-Westwood Cancer Center
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WestwoodUnited StatesRecruiting
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesRecruiting
University of Michigan Health - West
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WyomingUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.