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NCT04640623Active, not recruitingPhase 2

A Study of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the overall complete response (CR) rate in participants treated with TAR-200 in combination with cetrelimab (Cohort 1), or TAR-200 alone (Cohort 2), or cetrelimab alone (Cohort 3) with Carcinoma in Situ (CIS), with or without concomitant high-grade Ta or T1 papillary disease; and disease-free survival (DFS) in participants treated with TAR-200 alone with papillary disease only (Cohort 4).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
220 (actual)
First submitted
20 Nov 2020
Start date
18 Dec 2020
Primary completion date
3 Jul 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04640623
EU CT number
2023-506146-23-00
EudraCT number
2020-002646-16

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 220
  • From 18 Dec 2020 to the primary completion date, 3 Jul 2025
  • 113 sites in 16 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.

Prior treatment

  • Must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder. Ta/T1/CIS of the upper urinary tract (including renal pelvis and ureter) is allowable if treated with complete nephroureterectomy more than 24 months prior to randomization
  • Received a live virus vaccine within 30 days prior to the initiation of study treatment. Inactivated (non-live or non-replicating) vaccines approved or authorized for emergency use (for example, COVID-19) by local health authorities are allowed
  • Prior therapy with an anti-programmed-cell death 1 (PD-1), anti-PD-ligand 2 (L2) agent, or with an agent directed to another co-inhibitory T-cell receptor

Other illness

  • Presence or history of histologically confirmed, muscle-invasive, locally advanced, nonresectable, or metastatic urothelial carcinoma (that is, T2, T3, T4, and/or Stage IV)
  • Active hepatitis B or C infection (for example, participants with history of hepatitis C infection but undetectable hepatitis C virus polymerase chain reaction (PCR) test and participants with history of hepatitis B infection with positive hepatitis B surface antigen (HBsAg) antibody and undetectable PCR are allowed)

Who the study is looking for

  • Histologically confirmed diagnosis of persistent or recurrent high-risk non-muscle invasive bladder cancer (HR-NMIBC), (carcinoma in situ \[CIS\] or tumor in situ \[Tis\]), with or without papillary disease (T1, high-grade Ta) or papillary disease only (high-grade Ta or any T1 and absence of CIS), within 12 months of completion of the last dose of Bacillus Calmette-Guerin (BCG) therapy, in participants who have received adequate BCG. Mixed histology tumors are allowed if urothelial differentiation (transitional cell histology) is predominant. However, the presence of neuroendocrine, micropapillary, signet ring cell, plasmacytoid, or sarcomatoid features will make a participant ineligible. For participants with lamina propria invasion (T1) on the screening biopsy/ transurethral resection of bladder tumor (TURBT), muscularis propria must be present in order to rule out Muscle Invasive Bladder Cancer (MIBC)
  • All visible papillary disease must be fully resected (absent) prior to randomization (residual CIS is acceptable for participants eligible for Cohorts 1, 2, and 3 only) and documented in the electronic case report form (eCRF) at screening cystoscopy. For participants with papillary disease only (Cohort 4), local urine cytology at screening must be negative or atypical (for High-Grade Urothelial Carcinoma \[HGUC\])
  • Participants must be ineligible for or have elected not to undergo radical cystectomy
  • BCG-unresponsive high-risk NMIBC after treatment with adequate BCG therapy defined as a minimum of 5 of 6 full doses of an induction course (adequate induction) plus 2 of 3 doses of a maintenance course, or at least 2 of 6 doses of a second induction course
  • Eastern Cooperative Oncology Group (ECOG) performance status Grade 0, 1, or 2

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

Full criteria on ClinicalTrials.gov

Sites (113)

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

SiteCityCountrySite status
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Eastern Health Research
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Box HillAustraliaUnknown status
Macquarie University Hospital
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SydneyAustraliaUnknown status
Hopital Erasme
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AnderlechtBelgiumActive, not recruiting
AZ ST-JAN Brugge A.V.
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BruggeBelgiumActive, not recruiting
Az Sint-Lucas
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BruggeBelgiumActive, not recruiting
Az Maria Middelares Gent
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GentBelgiumActive, not recruiting
Universitair Ziekenhuis Gent
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GentBelgiumActive, not recruiting
Vitaz
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Sint-NiklaasBelgiumActive, not recruiting
Exdeo Clinical Research Inc
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Abbotsford British ColumbiaCanadaUnknown status
William Osler Health System
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BramptonCanadaUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
Université de Sherbrooke
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SherbrookeCanadaUnknown status
Princess Margaret Hospital- UHN
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TorontoCanadaUnknown status
Urologicum Duisburg
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DuisburgGermanyActive, not recruiting
Urologie Bayenthal
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KölnGermanyActive, not recruiting
Urologie Neandertal
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MettmannGermanyActive, not recruiting
Universitaet Muenster
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MuensterGermanyActive, not recruiting
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
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NuertingenGermanyActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Hospital Universitario Puerta del Mar
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CadizSpainActive, not recruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Virgen de la Victoria
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MálagaSpainActive, not recruiting
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceActive, not recruiting
Polyclinique Bordeaux Nord Aquitaine
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Bordeaux CedexFranceActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Clinique Du Parc
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Castelnauv Le LezFranceActive, not recruiting
Hopital Prive Sevigne
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Cesson SevigneFranceActive, not recruiting
Hopital Prive Toulon Hyeres Sainte Marguerite
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HyèresFranceActive, not recruiting
Polyclinique De Limoges
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Limoges Cedex IFranceActive, not recruiting
Hospital Edouard Herriot
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Lyon Cedex 03FranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Centre De Cancerologue Du Grand Montpellier
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MontpellierFranceActive, not recruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Centre Hospitalier Prive Saint Gregoire
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Saint-GrégoireFranceActive, not recruiting
Les Hopitaux Universitaires de Strasbourg
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StrasbourgFranceActive, not recruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceActive, not recruiting
NHS Greater Glasgow and Clyde
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GlasgowUnited KingdomUnknown status
Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomUnknown status
General Hospital Of Thessaloniki Papageorgiou
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EfkarpiaGreeceActive, not recruiting
General Hospital Of Thessloniki G Gennimatas
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ThessalonikiGreeceActive, not recruiting
University of Florence
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FlorenceItalyActive, not recruiting
Ospedale San Raffaele S.r.l.
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MilanItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Aso Co.,Ltd Iizuka Hospital
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IizukaJapanUnknown status
St Marianna University Hospital
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KanagawaJapanUnknown status
Nara Medical University Hospital
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Kashihara-shiJapanUnknown status
Kimitsu Chuo Hospital
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Kisarazu-shiJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
JOHAS Osaka Rosai Hospital
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OsakaJapanUnknown status
Toranomon Hospital
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TokyoJapanUnknown status
Toyama University Hospital
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ToyamaJapanUnknown status
Fujita Health University Hospital
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ToyoakeJapanUnknown status
University of Tsukuba Hospital
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TsukubaJapanUnknown status
Yokohama City University Medical Center
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YokohamaJapanUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
Keimyung University Dongsan Hospital
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DaeguSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Chonnam National University Hospital
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GwangjuSouth KoreaUnknown status
Gangnam Severance Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Severance hospital
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SeoulSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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YangsanSouth KoreaUnknown status
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
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AmsterdamNetherlandsActive, not recruiting
Canisius Wilhelmina Ziekenhuis
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NijmegenNetherlandsActive, not recruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalActive, not recruiting
Champalimaud Clinical Centre
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LisbonPortugalActive, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalActive, not recruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalActive, not recruiting
Hertzen Oncology Research Institute
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MoscowRussiaUnknown status
Privolzhsky District Medical Centre
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Nizhny NovgorodRussiaUnknown status
Avicenna Medical Center
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NovosibirskRussiaUnknown status
A. Tsyb Medical Radiological Research Center
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ObninskRussiaUnknown status
BHI of Omsk region "Clinical Oncology Dispensary"
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OmskRussiaUnknown status
Ultrasound Clinic 4D
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PyatigorskRussiaUnknown status
Saratov State Medical University
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SaratovRussiaUnknown status
Multifunctional clinical medical center 'Medical city'
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TyumenRussiaUnknown status
Bashkir State Medical University
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UfaRussiaUnknown status
Chernihivskyi oblasnyi onkolohichnyi dyspanser
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ChernihivUkraineUnknown status
Asklepion LLC
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KievUkraineUnknown status
Sumy Regional Clinical Oncology Centre
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SumyUkraineUnknown status
Urology Austin
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AustinUnited StatesUnknown status
Urologic Consultants of Southeastern Pennsylvania
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Bala-CynwydUnited StatesUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
The Urology Group
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CincinnatiUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
The Urology Center of Colorado
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DenverUnited StatesUnknown status
Foothills Urology - Golden Off
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GoldenUnited StatesUnknown status
Urology of Indiana
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GreenwoodUnited StatesUnknown status
DuPage Medical Group
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LisleUnited StatesUnknown status
University of Southern California
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Los AngelesUnited StatesUnknown status
Urology Associates PC
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NashvilleUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
NYU Langone Health
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New YorkUnited StatesUnknown status
Thomas Jefferson University
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PhiladelphiaUnited StatesUnknown status
Urology San Antonio Research
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San AntonioUnited StatesUnknown status
Genesis Healthcare Partners - Genesis Research Greater Los Angeles
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Sherman OaksUnited StatesUnknown status
Spokane Urology
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SpokaneUnited StatesUnknown status
SUNY Upstate Medical University
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SyracuseUnited StatesUnknown status
Associated Medical Professionals
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SyracuseUnited StatesUnknown status
Michigan Institute of Urology
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TroyUnited StatesUnknown status
Del Sol Research Management, LLC
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TucsonUnited StatesUnknown status
Wichita Urology Group
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WichitaUnited StatesUnknown status

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