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Brief Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)

A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)

INTRODUCTION

  • Org Study ID: 3475-676
  • Secondary ID: N/A
  • NCT ID: NCT03711032
  • Sponsor: Merck Sharp & Dohme LLC

BRIEF SUMMARY

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

  • Overall Status
    Recruiting
  • Start Date
    December 24, 2018
  • Phase
    Phase 3
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)

Primary Outcome 1 - Timeframe: Up to ~3.5 years

Primary Outcome 2 - Measure: Event-Free Survival (EFS) (Cohort B)

Primary Outcome 2 - Timeframe: Up to ~5 years

CONDITION

  • High-risk Non-muscle Invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
* Have locally and blinded independent central review (BICR)-confirmed histological diagnosis of high-risk non-muscle invasive (T1, high grade Ta and/or CIS) UC of the bladder

- * Has undergone cystoscopy/ transurethral resection of bladder tumor (TURBT) to remove all resectable disease

- * Has provided tissue for biomarker analysis

- * Has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

- * Has adequate organ function

- * During the treatment period and for ≥7 days after the last dose of BCG, male participants are EITHER abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent, OR, must agree to use contraception unless confirmed to be azoospermic

- * Female participants who are not pregnant, not breastfeeding, and either not a woman of child bearing potential (WOCBP); or are a WOCBP who agrees to use a contraception method that is highly effective or remains abstinent from heterosexual intercourse during the treatment period and for ≥7 days after the last dose of BCG or 120 days after the last dose of pembrolizumab, whichever comes last
BCG Post-induction Cohort (Cohort A) Only
* Has been treated with one adequate course of BCG induction therapy for the treatment of HR NMIBC

- * Following adequate BCG induction therapy, must have persistent or recurrent HR NMIBC
Exclusion Criteria:
* Has a history of or concurrent locally advanced (i.e., T2, T3, T4) or metastatic UC

- * Has concurrent extra-vesical (i.e, urethra, ureter, renal pelvis) non-muscle invasive urothelial carcinoma or a history of extra-vesical non-muscle invasive UC

- * Has received prior therapy with anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor

- * Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks of start of study treatment

- * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks of start of study treatment

- * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days of start of study treatment

- * Has a known additional malignancy that is progressing or requires active treatment within the past 3 years

- * Has an active autoimmune disease that has required systemic treatment in past 2 years

- * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

- * Has one or more of the following contraindications to BCG: prior BCG sepsis or systemic infection, total bladder incontinence, or an adverse experience to a previous BCG instillation that resulted in treatment discontinuation and precludes retreating with BCG

- * Has an active infection or diagnosis requiring systemic antimicrobial therapy

- * Has a known history of human immunodeficiency virus (HIV) infection

- * Has a known history of Hepatitis B or known active Hepatitis C virus infection

- * Has current active tuberculosis

- * Has had an allogenic-tissue/solid organ transplant

- * Has any contraindication(s) to IV contrast or is otherwise unable to have screening imaging with IV contrast performed
BCG Post-induction Cohort (Cohort A) Only - Has persistent T1 disease following an induction course of BCG
BCG Naïve Cohort (Cohort B) Only
- Has received any prior treatment with BCG for their NMIBC within the past 2 years prior to study entry

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Medical Director

Role: Study Director

Affiliation: Merck Sharp & Dohme LLC

Overall Contact

Name: Medical Director

Phone: 1-888-577-8839

Email: Trialsites@merck.com

LOCATION

Facility Status Contact
Facility: Mayo Clinic in Arizona - Phoenix ( Site 1094)
Phoenix, Arizona 85054
United States
Status: Recruiting Contact: Contact
Study Coordinator
480-342-6672

Facility: Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)
Tucson, Arizona 85704
United States
Status: Recruiting Contact: Contact
Study Coordinator
520-618-1010

Facility: University of California Irvine Medical Center ( Site 1061)
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Study Coordinator
714-456-8148

Facility: Genesis Research LLC ( Site 1065)
Torrance, California 90505
United States
Status: Recruiting Contact: Contact
Study Coordinator
310-602-5005

Facility: Colorado Clinical Research ( Site 1100)
Lakewood, Colorado 80228
United States
Status: Recruiting Contact: Contact
Study Coordinator
303-996-9649

Facility: Urological Research Network ( Site 1106)
Hialeah, Florida 33016
United States
Status: Recruiting Contact: Contact
Study Coordinator
786-431-2014

Facility: Mayo Clinic in Florida-Urology ( Site 1097)
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Study Coordinator
904-953-7330

Facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)
Miami, Florida 33136
United States
Status: Recruiting Contact: Contact
Study Coordinator
305-243-2177

Facility: Emory School of Medicine ( Site 1076)
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Study Coordinator
404-778-4823

Facility: Advanced Urology ( Site 1092)
Roswell, Georgia 30076
United States
Status: Recruiting Contact: Contact
Study Coordinator
678-344-8900

Facility: Northwestern Memorial Hospital ( Site 1101)
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
Study Coordinator
312-695-4484

Facility: Wichita Urology Group ( Site 1086)
Wichita, Kansas 67226
United States
Status: Recruiting Contact: Contact
Study Coordinator
316-636-6141

Facility: Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)
Shreveport, Louisiana 71106
United States
Status: Recruiting Contact: Contact
Study Coordinator
318-683-0411

Facility: Henry Ford Health System ( Site 1062)
Detroit, Michigan 48202
United States
Status: Recruiting Contact: Contact
Study Coordinator
313-916-8862

Facility: Michigan Institute of Urology ( Site 1077)
Troy, Michigan 48084
United States
Status: Recruiting Contact: Contact
Study Coordinator
248-786-0467

Facility: Morristown Medical Center ( Site 1090)
Morristown, New Jersey 07960
United States
Status: Recruiting Contact: Contact
Study Coordinator
973-971-5373

Facility: Monter Cancer Center ( Site 1080)
Lake Success, New York 11042
United States
Status: Recruiting Contact: Contact
Study Coordinator
516-734-8500

Facility: Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)
New York, New York 10010
United States
Status: Recruiting Contact: Contact
Study Coordinator
2126867500 ext.6383

Facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)
New York, New York 10016
United States
Status: Recruiting Contact: Contact
Study Coordinator
646-501-8206

Facility: TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: Contact
Study Coordinator
513-841-7555

Facility: Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10
Columbus, Ohio 43210
United States
Status: Recruiting Contact: Contact
Study Coordinator
614-366-7421

Facility: Oregon Urology Institute ( Site 1098)
Springfield, Oregon 97477
United States
Status: Recruiting Contact: Contact
Study Coordinator
541-284-5508

Facility: MidLantic Urology ( Site 1071)
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Study Coordinator
610-667-0458

Facility: Lancaster Urology ( Site 1079)
Lancaster, Pennsylvania 17604
United States
Status: Recruiting Contact: Contact
Study Coordinator
717-431-2285

Facility: University of Pennsylvania ( Site 1088)
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Study Coordinator
215-662-2891

Facility: Carolina Urologic Research Center ( Site 1085)
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Study Coordinator
8434491010257

Facility: Urology Associates [Nashville, TN] ( Site 1072)
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Study Coordinator
615-250-9268

Facility: Urology Clinics of North Texas, PLLC ( Site 1064)
Dallas, Texas 75231
United States
Status: Recruiting Contact: Contact
Study Coordinator
214-580-1485

Facility: University Of Texas Southwestern Medical Center ( Site 1053)
Dallas, Texas 75390
United States
Status: Recruiting Contact: Contact
Study Coordinator
214-645-8787

Facility: Houston Metro Urology ( Site 1111)
Houston, Texas 77027
United States
Status: Recruiting Contact: Contact
Study Coordinator
832-549-4395

Facility: Urology San Antonio Research ( Site 1108)
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Study Coordinator
832-472-5482

Facility: University of Vermont Medical Center ( Site 1057)
Burlington, Vermont 05401
United States
Status: Recruiting Contact: Contact
Study Coordinator
802-656-9926

Facility: Urology of Virginia ( Site 1070)
Virginia Beach, Virginia 23462
United States
Status: Recruiting Contact: Contact
Study Coordinator
757-452-3463

Facility: GenesisCare North Shore ( Site 0010)
St Leonards, New South Wales 2065
Australia
Status: Recruiting Contact: Contact
Study Coordinator
61294631172

Facility: Epworth Hospital ( Site 0009)
Richmond, Victoria 3121
Australia
Status: Recruiting Contact: Contact
Study Coordinator
0390085443

Facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)
Linz, Oberosterreich 4020
Austria
Status: Recruiting Contact: Contact
Study Coordinator
+4373276777727

Facility: Medizinische Universität Wien ( Site 0054)
Vienna, Wien 1090
Austria
Status: Recruiting Contact: Contact
Study Coordinator
+4367761942300

Facility: Universitaetsklinik Salzburg ( Site 0053)
Salzburg, 5020
Austria
Status: Recruiting Contact: Contact
Study Coordinator
+435725527400

Facility: UZA University Hospital Antwerp ( Site 0105)
Edegem, Antwerpen 2650
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3238213718

Facility: CHU UCL Namur Site de Godinne ( Site 0103)
Yvoir, Namur 5530
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3281423858

Facility: O.L.V. Ziekenhuis Aalst ( Site 0106)
Aalst, Oost-Vlaanderen 9300
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3253724378

Facility: AZ Maria Middelares Gent ( Site 0102)
Gent, Oost-Vlaanderen 9000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3292469522

Facility: UZ Gent ( Site 0101)
Gent, Oost-Vlaanderen 9000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+3293322811

Facility: Hospital São Carlos-Oncocentro Ce ( Site 1558)
Fortaleza, Ceara 60135-237
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
+5585981023963

Facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)
Curitiba, Parana 81520060
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
+554133615195

Facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)
Barretos, Sao Paulo 14784400
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
5517 3321.6637

Facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)
São Paulo, Sao Paulo 01246-000
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
551138058871

Facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)
São Paulo, Sao Paulo 04014-002
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
+551144500300

Facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)
Sao Paulo, 01321-001
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
5511981982259

Facility: Exdeo Clinical Research Inc. ( Site 0165)
Abbotsford, British Columbia V2T 1X8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
6048515667

Facility: Horizon Health Network ( Site 0160)
Moncton, New Brunswick E1C 6Z8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
5068574780

Facility: Princess Margaret Cancer Centre ( Site 0153)
Toronto, Ontario M5G 2M9
Canada
Status: Recruiting Contact: Contact
Study Coordinator
4169462246

Facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)
Chicoutimi, Quebec G7H 5H6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
4185411000

Facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)
Montreal, Quebec H1T 2M4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
5142523400x5766

Facility: CHUS - Hopital Fleurimont ( Site 0152)
Sherbrooke, Quebec J1H 5N4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
8193461110x12827

Facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec, G1J 1Z4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
418525444420414

Facility: Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)
Beijing, Beijing 100021
China
Status: Recruiting Contact: Contact
Study Coordinator
18601238866

Facility: Peking University First Hospital ( Site 1759)
Beijing, Beijing 100034
China
Status: Recruiting Contact: Contact
Study Coordinator
+8613910688432

Facility: Beijing Cancer hospital-Urinary Surgery ( Site 1755)
Beijing, Beijing 100142
China
Status: Recruiting Contact: Contact
Study Coordinator
13910571565

Facility: The First Affiliated hospital of Xiamen University-Urology ( Site 1776)
Xiamen, Fujian 361003
China
Status: Recruiting Contact: Contact
Study Coordinator
8613806089889

Facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)
Guangzhou, Guangdong 510060
China
Status: Recruiting Contact: Contact
Study Coordinator
020-87343392

Facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)
Guangzhou, Guangdong 510120
China
Status: Recruiting Contact: Contact
Study Coordinator
020-81332371

Facility: The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777)
Guangzhou, Guangdong 510120
China
Status: Recruiting Contact: Contact
Study Coordinator
(8620) 34294311

Facility: ShenZhen People's Hospital ( Site 1778)
Shenzhen, Guangdong 518020
China
Status: Recruiting Contact: Contact
Study Coordinator
0755-25533018

Facility: Harbin Medical University Cancer Hospital-urology ( Site 1772)
Harbin, Heilongjiang 150081
China
Status: Recruiting Contact: Contact
Study Coordinator
+8613603612355

Facility: Henan Cancer Hospital-Urology ( Site 1770)
Zhengzhou, Henan 450008
China
Status: Recruiting Contact: Contact
Study Coordinator
+8615981828716

Facility: Wuhan Union Hospital ( Site 1771)
Wuhan, Hubei 430022
China
Status: Recruiting Contact: Contact
Study Coordinator
18602752025

Facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)
Wuhan, Hubei 430030
China
Status: Recruiting Contact: Contact
Study Coordinator
13367255851

Facility: Hunan Cancer Hospital ( Site 1763)
Changsha, Hunan 410013
China
Status: Recruiting Contact: Contact
Study Coordinator
+86 13207139095

Facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Nanjing, Jiangsu 210000
China
Status: Recruiting Contact: Contact
Study Coordinator
+8602583106666

Facility: The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)
Suzhou, Jiangsu 215004
China
Status: Recruiting Contact: Contact
Study Coordinator
18994392817

Facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)
Xi'an, Shaanxi 710061
China
Status: Recruiting Contact: Contact
Study Coordinator
+86 18149480558

Facility: West China Hospital Sichuan University ( Site 1767)
Cheng Du, Sichuan 610041
China
Status: Recruiting Contact: Contact
Study Coordinator
(028)85164161

Facility: The Second Hospital of Tianjin Medical University ( Site 1769)
Tianjin, Tianjin 300211
China
Status: Recruiting Contact: Contact
Study Coordinator
13662096232

Facility: Zhejiang Provincial People's Hospital-Urology ( Site 1762)
Hangzhou, Zhejiang 310014
China
Status: Recruiting Contact: Contact
Study Coordinator
0571-85893008

Facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)
Wenzhou, Zhejiang 325000
China
Status: Recruiting Contact: Contact
Study Coordinator
0577-55579590

Facility: Instituto de Cancerología-Oncology ( Site 1609)
Medellín, Antioquia 050024
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
3183065866

Facility: Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad
Rionegro, Antioquia 054047
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
3176594902

Facility: Oncomedica S.A.-Oncomedica S.A ( Site 1604)
Montería, Cordoba 230001
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
57-3226138826

Facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)
Bogota, Distrito Capital De Bogota 111321
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
573108965914

Facility: Administradora Country S.A. - Clinica del Country ( Site 1607)
Bogotá, Distrito Capital De Bogota 110221
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
573174365020

Facility: Oncologos del Occidente ( Site 1608)
Pereira, Risaralda 660001
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
573123887343

Facility: Hemato Oncologos SA-Oncology ( Site 1601)
Cali, Valle Del Cauca 76001
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
573212195102

Facility: Clínica Imbanaco S.A.S ( Site 1611)
Cali, Valle Del Cauca
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
573155028668

Facility: CIMCA ( Site 1550)
San José, San Jose 10103
Costa Rica
Status: Recruiting Contact: Contact
Study Coordinator
+50683893636

Facility: Policlinico San Bosco ( Site 0600)
San Jose, 10103
Costa Rica
Status: Recruiting Contact: Contact
Study Coordinator
+50683384787

Facility: Tampere University Hospital [Tampere Finland] ( Site 0201)
Tampere, Pirkanmaa 33520
Finland
Status: Recruiting Contact: Contact
Study Coordinator
+358331164621

Facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)
Dijon, Bourgogne 21000
France
Status: Recruiting Contact: Contact
Study Coordinator
33380293761

Facility: Hôpital Foch-Urology department ( Site 1351)
Suresnes, Hauts-de-Seine 92150
France
Status: Recruiting Contact: Contact
Study Coordinator
+33146251961

Facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)
Rennes, Ille-et-Vilaine 35033
France
Status: Recruiting Contact: Contact
Study Coordinator
33299284270

Facility: Hopital Claude Huriez - CHU de Lille ( Site 1360)
Lille, Nord 59037
France
Status: Recruiting Contact: Contact
Study Coordinator
0320444398

Facility: HENRI MONDOR HOSPITAL ( Site 1357)
Créteil, Seine-et-Marne 94000
France
Status: Recruiting Contact: Contact
Study Coordinator
+33145178243

Facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)
Munich, Bayern 81675
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+498941402522

Facility: Klinikum Weiden ( Site 0259)
Weiden In Der Oberpfalz, Bayern 92637
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+49963033302

Facility: Universitaetsklinikum Wuerzburg ( Site 0265)
Wuerzburg, Bayern 97080
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+4993120132037

Facility: Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)
Trier, Rheinland-Pfalz 54292
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+496512082680

Facility: Universitaetsklinikum Jena ( Site 0252)
Jena, Thuringen 07747
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+49-3641-9-329901

Facility: Olympion General Clinic ( Site 0306)
Patras, Achaia 264 43
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+302610464064

Facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)
Chaidari, Attiki 124 62
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+302105831255

Facility: University Hospital of Larissa ( Site 0301)
Larissa, Thessalia 411 10
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+302413502811

Facility: Intervasc ( Site 1454)
Guatemala City, 01010
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+50259042511

Facility: INTEGRA Cancer Institute ( Site 1451)
Guatemala, 01010
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+50222790939

Facility: Grupo Medico Angeles-Grupo Medico Angeles ( Site 1453)
Guatemala, 01015
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+50240492110

Facility: Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)
Pécs, Baranya 7621
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
3672507323

Facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)
Szeged, Csongrad 6725
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+36709411312

Facility: Semmelweis University-Urológiai Klinika ( Site 1301)
Budapest, 1082
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+36208258762

Facility: Debreceni Egyetem Klinikai Kozpont ( Site 1302)
Debrecen, 4032
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+36308544051

Facility: Ospedale Clinicizzato Santissima Annunziata ( Site 0361)
Chieti, Abruzzo 66100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390871357783

Facility: Ospedale San Raffaele ( Site 0362)
Milano, Lombardia 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+39022643789

Facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)
Milan, Milano 20133
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390223902402

Facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)
Torino, Piemonte 10128
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+39 0115082032

Facility: Azienda Ospedaliero Universitaria Careggi ( Site 0360)
Firenze, Toscana 50134
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390557949920

Facility: Osp Generale Reg di Bolzano ( Site 0355)
Bolzano, Trentino-Sudtirol 39100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390471908953

Facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)
Arezzo, 52100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390575255436

Facility: Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)
Palermo, 90123
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+39091479432

Facility: Policlinico Universitario A. Gemelli ( Site 0358)
Roma, 00168
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390630154953

Facility: A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)
Verona, 37126
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+390458123876

Facility: Hirosaki University Hospital ( Site 0407)
Hirosaki, Aomori 036-8563
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81172335111

Facility: Ehime University Hospital ( Site 0414)
Toon, Ehime 791-0295
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81899645111

Facility: University of Tsukuba Hospital ( Site 0412)
Tsukuba, Ibaraki 305-8576
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81298533900

Facility: St. Marianna University Hospital ( Site 0415)
Kawasaki, Kanagawa 216-8511
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-44-977-8111

Facility: Kitasato University Hospital ( Site 0403)
Sagamihara, Kanagawa 252-0375
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81427788111

Facility: Yokosuka Kyosai Hospital ( Site 0406)
Yokosuka, Kanagawa 238-8558
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81468222710

Facility: Nara Medical University Hospital ( Site 0411)
Kashihara, Nara 634-8522
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81744223051

Facility: Hamamatsu University Hospital ( Site 0416)
Hamamatsu, Shizuoka 431-3192
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81-53-435-2111

Facility: Chiba Cancer Center ( Site 0401)
Chiba, 260-8717
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81432645431

Facility: Harasanshin Hospital ( Site 0410)
Fukuoka, 812-0033
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81922913434

Facility: Osaka International Cancer Institute ( Site 0413)
Osaka, 541-8567
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81669451181

Facility: Osaka Metropolitan University Hospital ( Site 0404)
Osaka, 545-8586
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81666452121

Facility: Tokyo Medical and Dental University Hospital ( Site 0409)
Tokyo, 113-8519
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81338136111

Facility: Keio University Hospital ( Site 0405)
Tokyo, 160-8582
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+81333531211

Facility: Korea University Anam Hospital ( Site 0801)
Seoul, 02841
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+821099288097

Facility: Seoul National University Hospital ( Site 0802)
Seoul, 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+82220720361

Facility: Maastricht University Medical Centre ( Site 0453)
Maastricht, Limburg 6202AZ
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+31433876543

Facility: Erasmus MC ( Site 0451)
Rotterdam, Zuid-Holland 3015GD
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+31107040704

Facility: Akershus University Hospital ( Site 0553)
Lorenskog, Akershus 1478
Norway
Status: Recruiting Contact: Contact
Study Coordinator
+4767960000

Facility: Stavanger universitetssykehus ( Site 0555)
Stavanger, Rogaland 4011
Norway
Status: Recruiting Contact: Contact
Study Coordinator
+4751518000

Facility: Oncosalud ( Site 0603)
Lima, Muni Metro De Lima 15036
Peru
Status: Recruiting Contact: Contact
Study Coordinator
+51992756559

Facility: Hospital Militar Central [Lima, Peru] ( Site 0604)
Lima, 15076
Peru
Status: Recruiting Contact: Contact
Study Coordinator
+51997468543

Facility: Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)
Wroclaw, Dolnoslaskie 50-556
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48601143281

Facility: Nasz Lekarz Przychodnie Medyczne ( Site 0679)
Torun, Kujawsko-pomorskie 87-100
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48563004380

Facility: Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)
Tarnow, Malopolskie 33-100
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48728355694

Facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
Siedlce, Mazowieckie 08-110
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48504283093

Facility: Medical Concierge Centrum Medyczne ( Site 0676)
Warsaw, Mazowieckie 02-798
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48224166500

Facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)
Przemysl, Podkarpackie 37-700
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48661957237

Facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)
Slupsk, Pomorskie 76-200
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48598460340

Facility: Clinical Research Center Sp. z o.o. ( Site 0674)
Poznan, Wielkopolskie 61-731
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+48616632513

Facility: 2CA Braga. Centro Clinico Academico ( Site 0705)
Braga, 4710-243
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+351253027249

Facility: CHLN Hospital Santa Maria ( Site 0702)
Lisboa, 1649-035
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+351217805056

Facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)
Porto, 4200-072
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+351225084000

Facility: Advance Urology and Laparoscopic Center ( Site 0757)
Ponce, 00716
Puerto Rico
Status: Recruiting Contact: Contact
Study Coordinator
7874329059

Facility: Ad-Vance Medical Research ( Site 0756)
Ponce, 00717
Puerto Rico
Status: Recruiting Contact: Contact
Study Coordinator
7878406448

Facility: Hospital Universitario Lucus Augusti ( Site 0852)
Lugo, La Coruna 27003
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34982296459

Facility: Hospital Universitario Quiron Madrid ( Site 0862)
Pozuelo de Alarcon, Madrid, Comunidad De 28223
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34914521987

Facility: Fundacio Puigvert ( Site 0864)
Barcelona, 08025
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34934169700

Facility: Hospital Universitario Gregorio Maranon ( Site 0854)
Madrid, 28007
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34914269070

Facility: MD Anderson Cancer Center Madrid ( Site 0859)
Madrid, 28033
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34917878600

Facility: Hospital Universitario Ramon y Cajal ( Site 0857)
Madrid, 28034
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34913368263

Facility: Hospital Universitario La Paz ( Site 0866)
Madrid, 28046
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34 912 071 876

Facility: Hospital La Fe de Valencia ( Site 0855)
Valencia, 46026
Spain
Status: Recruiting Contact: Contact
Study Coordinator
+34961244188

Facility: Universitaetsspital Basel ( Site 1201)
Basel, Basel-Stadt 4031
Switzerland
Status: Recruiting Contact: Contact
Study Coordinator
+41615565477

Facility: Hopitaux Universitaires de Geneve HUG ( Site 1204)
Geneve, 1205
Switzerland
Status: Recruiting Contact: Contact
Study Coordinator
+41223727876

Facility: Universitaetsspital Zurich ( Site 1203)
Zurich, 8091
Switzerland
Status: Recruiting Contact: Contact
Study Coordinator
+41442555440

Facility: China Medical University Hospital-Department of Urology ( Site 1654)
Taichung, 40447
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
+886422052121 ext.4440

Facility: Taichung Veterans General Hospital ( Site 1653)
Taichung, 407
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
886-4-2359-2525 ext.5124

Facility: Taipei Veterans General Hospital ( Site 1652)
Taipei, 11217
Taiwan
Status: Recruiting Contact: Contact
Study Coordinator
886-2-28757519#306

Facility: Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)
Ankara, 06590
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
0905337483275

Facility: Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)
Eskisehir, 26480
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905327149696

Facility: Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)
Istanbul, 34385
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905325755400

Facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)
Istanbul, 34722
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905323430723

Facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)
Konya, 42000
Turkey
Status: Recruiting Contact: Contact
Study Coordinator
+905322679838

Facility: Raigmore Hospital ( Site 1006)
Inverness, Highland IV2 3UJ
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+4401463706356

Facility: St Bartholomew s Hospital ( Site 1008)
London, London, City Of EC1A 7BE
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+442078828505

Facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1005)
London, London, City Of SW17 0QT
United Kingdom
Status: Recruiting Contact: Contact
Study Coordinator
+442087253362