English Español
Back to Clinical Trials

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: MK-3475-676, 194713, 2018-001967-22
  • NTC ID: NCT03711032
  • Sponsor: Merck Sharp & Dohme LLC
Merck Oncology Clinical Trials Information

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
520-618-1010
Facility: Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)
Tucson, Arizona 85704
United States
Status: Recruiting Contact: Contact
Study Coordinator
714-456-8148
Facility: University of California Irvine Medical Center ( Site 1061)
Orange, California 92868
United States
Status: Recruiting Contact: Contact
Study Coordinator
303-996-9649
Facility: Genesis Research LLC ( Site 1065)
Torrance, California 90505
United States
Status: Recruiting Contact: Contact
Study Coordinator
786-431-2014
Facility: Colorado Clinical Research ( Site 1100)
Lakewood, Colorado 80228
United States
Status: Recruiting Contact: Contact
Study Coordinator
904-953-7330
Facility: Urological Research Network ( Site 1106)
Hialeah, Florida 33016
United States
Status: Recruiting Contact: Contact
Study Coordinator
305-243-2177
Facility: Mayo Clinic in Florida-Urology ( Site 1097)
Jacksonville, Florida 32224
United States
Status: Recruiting Contact: Contact
Study Coordinator
404-778-4823
Facility: Sylvester Comprehensive Cancer Center ( Site 1056)
Miami, Florida 33136
United States
Status: Recruiting Contact: Contact
Study Coordinator
678-344-8900
Facility: Emory School of Medicine ( Site 1076)
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Study Coordinator
316-636-6141
Facility: Advanced Urology ( Site 1092)
Roswell, Georgia 30076
United States
Status: Recruiting Contact: Contact
Study Coordinator
318-683-0411
Facility: Northwestern Memorial Hospital ( Site 1101)
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Contact
Study Coordinator
313-916-8862
Facility: Wichita Urology Group ( Site 1086)
Wichita, Kansas 67226
United States
Status: Recruiting Contact: Contact
Study Coordinator
248-786-0467
Facility: Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)
Shreveport, Louisiana 71106
United States
Status: Recruiting Contact: Contact
Study Coordinator
973-971-5373
Facility: Henry Ford Health System ( Site 1062)
Detroit, Michigan 48202
United States
Status: Recruiting Contact: Contact
Study Coordinator
516-734-8500
Facility: Michigan Institute of Urology ( Site 1077)
Troy, Michigan 48084
United States
Status: Recruiting Contact: Contact
Study Coordinator
2126867500 ext.6383
Facility: Morristown Medical Center ( Site 1090)
Morristown, New Jersey 07960
United States
Status: Recruiting Contact: Contact
Study Coordinator
513-841-7555
Facility: Monter Cancer Center ( Site 1080)
Lake Success, New York 11042
United States
Status: Recruiting Contact: Contact
Study Coordinator
610-667-0458
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
717-431-2285
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
215-662-2891
Facility: Tri-State Urologic Services PSC, Inc. ( Site 1091)
Cincinnati, Ohio 45212
United States
Status: Recruiting Contact: Contact
Study Coordinator
615-250-9268
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
214-645-8787
Facility: Oregon Urology Institute ( Site 1098)
Springfield, Oregon 97477
United States
Status: Recruiting Contact: Contact
Study Coordinator
832-472-5482
Facility: MidLantic Urology ( Site 1071)
Bala-Cynwyd, Pennsylvania 19004
United States
Status: Recruiting Contact: Contact
Study Coordinator
802-656-9926
Facility: Lancaster Urology ( Site 1079)
Lancaster, Pennsylvania 17604
United States
Status: Recruiting Contact: Contact
Study Coordinator
757-452-3463
Facility: University of Pennsylvania ( Site 1088)
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Study Coordinator
+4373276777727
Facility: Carolina Urologic Research Center ( Site 1085)
Myrtle Beach, South Carolina 29572
United States
Status: Recruiting Contact: Contact
Study Coordinator
+4367761942300
Facility: Urology Associates [Nashville, TN] ( Site 1072)
Nashville, Tennessee 37209
United States
Status: Recruiting Contact: Contact
Study Coordinator
+435725527400
Facility: Urology Clinics of North Texas, PLLC ( Site 1064)
Dallas, Texas 75231
United States
Status: Recruiting Contact: Contact
Study Coordinator
+3238213718
Facility: University Of Texas Southwestern Medical Center ( Site 1053)
Dallas, Texas 75390-8843
United States
Status: Recruiting Contact: Contact
Study Coordinator
+3281423858
Facility: Houston Metro Urology ( Site 1111)
Houston, Texas 77027
United States
Status: Recruiting Contact: Contact
Study Coordinator
+3292469522
Facility: Urology San Antonio Research ( Site 1108)
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Study Coordinator
+5585981023963
Facility: University of Vermont Medical Center ( Site 1057)
Burlington, Vermont 05401
United States
Status: Recruiting Contact: Contact
Study Coordinator
+554133615195
Facility: Urology of Virginia ( Site 1070)
Virginia Beach, Virginia 23462
United States
Status: Recruiting Contact: Contact
Study Coordinator
5517 3321.6637
Facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)
Linz, Oberosterreich 4020
Austria
Status: Recruiting Contact: Contact
Study Coordinator
6048515667
Facility: Medizinische Universität Wien ( Site 0054)
Vienna, Wien 1090
Austria
Status: Recruiting Contact: Contact
Study Coordinator
4169462246
Facility: Universitaetsklinik Salzburg ( Site 0053)
Salzburg, Antwerpen 5020
Austria
Status: Recruiting Contact: Contact
Study Coordinator
4185411000
Facility: UZA University Hospital Antwerp ( Site 0105)
Edegem, Namur 2650
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
5142523400x5766
Facility: CHU UCL Namur Site de Godinne ( Site 0103)
Yvoir, Oost-Vlaanderen 5530
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
418525444420414
Facility: O.L.V. Ziekenhuis Aalst ( Site 0106)
Aalst, Oost-Vlaanderen 9300
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
8193461110x12827
Facility: AZ Maria Middelares Gent ( Site 0102)
Gent, Oost-Vlaanderen 9000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+86 13207139095
Facility: UZ Gent ( Site 0101)
Gent, Ceara 9000
Belgium
Status: Recruiting Contact: Contact
Study Coordinator
+8602583106666
Facility: Hospital São Carlos-Oncocentro Ce ( Site 1558)
Fortaleza, Parana 60135-237
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
0577-55579590
Facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)
Curitiba, Sao Paulo 81520-060
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
3176594902
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
57-3226138826
Facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)
São Paulo, British Columbia 04014-002
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
573108965914
Facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)
Sao Paulo, British Columbia 01321-001
Brazil
Status: Recruiting Contact: Contact
Study Coordinator
573174365020
Facility: Exdeo Clinical Research Inc. ( Site 0165)
Abbotsford, New Brunswick V2T 1X8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
573123887343
Facility: Horizon Health Network ( Site 0160)
Moncton, Quebec E1C 6Z8
Canada
Status: Recruiting Contact: Contact
Study Coordinator
573155028668
Facility: Princess Margaret Cancer Centre ( Site 0153)
Toronto, Quebec M5G 2M9
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+50683893636
Facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)
Chicoutimi, Quebec G7H 5H6
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+50683384787
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
+358331164621
Facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec City, Hunan G1J 1Z4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
33380293761
Facility: CHUS - Hopital Fleurimont ( Site 0152)
Sherbrooke, Jiangsu J1H 5N4
Canada
Status: Recruiting Contact: Contact
Study Coordinator
+33146251961
Facility: Hunan Cancer Hospital ( Site 1763)
Changsha, Zhejiang 410013
China
Status: Recruiting Contact: Contact
Study Coordinator
33299284270
Facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Nanjing, Antioquia 210000
China
Status: Recruiting Contact: Contact
Study Coordinator
+33145178243
Facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)
Wenzhou, Cordoba 325000
China
Status: Recruiting Contact: Contact
Study Coordinator
+498941402522
Facility: Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad
Rionegro, Distrito Capital De Bogota 054047
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+49963033302
Facility: Oncomedica S.A.-Oncomedica S.A ( Site 1604)
Montería, Distrito Capital De Bogota 230001
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+4993120132037
Facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)
Bogota, Risaralda 111321
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+496512082680
Facility: Administradora Country S.A. - Clinica del Country ( Site 1607)
Bogotá, Valle Del Cauca 110221
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+49-3641-9-329901
Facility: Oncologos del Occidente ( Site 1608)
Pereira, Valle Del Cauca 660001
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+302610999791
Facility: Hemato Oncologos SA-Oncology ( Site 1601)
Cali, San Jose 76001
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+302105831255
Facility: Instituto de investigaciones Centro Medico Imbanaco ( Site 1611)
Cali, Pirkanmaa 10103
Colombia
Status: Recruiting Contact: Contact
Study Coordinator
+302310898721
Facility: CIMCA ( Site 1550)
San José, Bourgogne 10103
Costa Rica
Status: Recruiting Contact: Contact
Study Coordinator
+302413502811
Facility: Policlinico San Bosco ( Site 0600)
San Jose, Hauts-de-Seine 33520
Costa Rica
Status: Recruiting Contact: Contact
Study Coordinator
+50259042511
Facility: Tampere University Hospital [Tampere Finland] ( Site 0201)
Tampere, Ille-et-Vilaine 21079
Finland
Status: Recruiting Contact: Contact
Study Coordinator
+50222790939
Facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)
Dijon, Seine-et-Marne 92150
France
Status: Recruiting Contact: Contact
Study Coordinator
+50240492110
Facility: Hôpital Foch-Urology department ( Site 1351)
Suresnes, Bayern 35033
France
Status: Recruiting Contact: Contact
Study Coordinator
3672507323
Facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)
Rennes, Bayern 94000
France
Status: Recruiting Contact: Contact
Study Coordinator
+36709411312
Facility: HENRI MONDOR HOSPITAL ( Site 1357)
Créteil, Bayern 81675
France
Status: Recruiting Contact: Contact
Study Coordinator
+36208258762
Facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)
Munich, Rheinland-Pfalz 92637
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+36308544051
Facility: Klinikum Weiden ( Site 0259)
Weiden In Der Oberpfalz, Thuringen 97080
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+390871357783
Facility: Universitaetsklinikum Wuerzburg ( Site 0265)
Wuerzburg, Achaia 54292
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+39022643789
Facility: Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)
Trier, Attiki 07747
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+390223902402
Facility: Universitaetsklinikum Jena ( Site 0252)
Jena, Kentriki Makedonia 265 04
Germany
Status: Recruiting Contact: Contact
Study Coordinator
+39 0115082032
Facility: General University Hospital of Patras ( Site 0302)
Patra, Thessalia 124 62
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+390557949920
Facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)
Chaidari, Baranya 54007
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+390471908953
Facility: Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)
Thessaloniki, Csongrad 411 10
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+390575255436
Facility: University Hospital of Larissa ( Site 0301)
Larissa, Abruzzo 01010
Greece
Status: Recruiting Contact: Contact
Study Coordinator
+39091479432
Facility: Intervasc ( Site 1454)
Guatemala City, Lombardia 01010
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+390630154953
Facility: INTEGRA Cancer Institute ( Site 1451)
Guatemala, Milano 01015
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+390458123876
Facility: Grupo Medico Angeles-Grupo Medico Angeles ( Site 1453)
Guatemala, Piemonte 7621
Guatemala
Status: Recruiting Contact: Contact
Study Coordinator
+81172335111
Facility: Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)
Pécs, Toscana 6725
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+81899645111
Facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)
Szeged, Trentino-Sudtirol 1082
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+81298533900
Facility: Semmelweis University-Urológiai Klinika ( Site 1301)
Budapest, Aomori 4032
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+81427788111
Facility: Debreceni Egyetem Klinikai Kozpont ( Site 1302)
Debrecen, Ehime 66100
Hungary
Status: Recruiting Contact: Contact
Study Coordinator
+81468222710
Facility: Ospedale Clinicizzato Santissima Annunziata ( Site 0361)
Chieti, Ibaraki 20132
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81744223051
Facility: Ospedale San Raffaele ( Site 0362)
Milano, Kanagawa 20133
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81-53-435-2111
Facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)
Milan, Kanagawa 10128
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81432645431
Facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)
Torino, Nara 50134
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81922913434
Facility: Azienda Ospedaliero Universitaria Careggi ( Site 0360)
Firenze, Shizuoka 39100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81669451181
Facility: Osp Generale Reg di Bolzano ( Site 0355)
Bolzano, Seoul 52100
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81666452121
Facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)
Arezzo, Limburg 70124
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+81338136111
Facility: Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)
Palermo, Rogaland 00168
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+82220720361
Facility: Policlinico Universitario A. Gemelli ( Site 0358)
Roma, Lima 37126
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+31433876543
Facility: A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)
Verona, Muni Metro De Lima 036-8563
Italy
Status: Recruiting Contact: Contact
Study Coordinator
+31107040704
Facility: Hirosaki University Hospital ( Site 0407)
Hirosaki, Dolnoslaskie 791-0295
Japan
Status: Recruiting Contact: Contact
Study Coordinator
31887556308
Facility: Ehime University Hospital ( Site 0414)
Toon, Kujawsko-pomorskie 305-8576
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+4767960000
Facility: University of Tsukuba Hospital ( Site 0412)
Tsukuba, Malopolskie 252-0375
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+4751518000
Facility: Kitasato University Hospital ( Site 0403)
Sagamihara, Malopolskie 238-8558
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+51992756559
Facility: Yokosuka Kyosai Hospital ( Site 0406)
Yokosuka, Mazowieckie 634-8522
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+51997468543
Facility: Nara Medical University Hospital ( Site 0411)
Kashihara, Mazowieckie 431-3192
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+48601143281
Facility: Hamamatsu University Hospital ( Site 0416)
Hamamatsu, Mazowieckie 260-8717
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+48563004380
Facility: Chiba Cancer Center ( Site 0401)
Chiba, Podkarpackie 812-0033
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+48728355694
Facility: Harasanshin Hospital ( Site 0410)
Fukuoka, Pomorskie 5418567
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+48504283093
Facility: Osaka International Cancer Institute ( Site 0413)
Osaka, Pomorskie 545-8586
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+48224166500
Facility: Osaka Metropolitan University Hospital ( Site 0404)
Osaka, Slaskie 113-8519
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+48661957237
Facility: Tokyo Medical and Dental University Hospital ( Site 0409)
Tokyo, Wielkopolskie 160-8582
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+48598460340
Facility: Keio University Hospital ( Site 0405)
Tokyo, La Coruna 05505
Japan
Status: Recruiting Contact: Contact
Study Coordinator
+48616632513
Facility: Korea University Anam Hospital ( Site 0801)
Seoul, Navarra 03080
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+351217805056
Facility: Seoul National University Hospital ( Site 0802)
Seoul, Basel-Stadt 06351
Korea, Republic of
Status: Recruiting Contact: Contact
Study Coordinator
+351225084000
Facility: Maastricht University Medical Centre ( Site 0453)
Maastricht, London, City Of 3015 GD
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+34982296459
Facility: Erasmus MC ( Site 0451)
Rotterdam, London, City Of 3584 CX
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+34914521987
Facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)
Utrecht, 1478
Netherlands
Status: Recruiting Contact: Contact
Study Coordinator
+34934169700
Facility: Akershus University Hospital ( Site 0553)
Lorenskog, 4011
Norway
Status: Recruiting Contact: Contact
Study Coordinator
+34914269070
Facility: Stavanger universitetssykehus ( Site 0555)
Stavanger, 15033
Norway
Status: Recruiting Contact: Contact
Study Coordinator
+34917878600
Facility: Oncosalud ( Site 0603)
Lima, 15076
Peru
Status: Recruiting Contact: Contact
Study Coordinator
+34 912 071 876
Facility: Hospital Militar Central [Lima, Peru] ( Site 0604)
Lima, 50-556
Peru
Status: Recruiting Contact: Contact
Study Coordinator
+34961244188
Facility: Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)
Wroclaw, 87-100
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+41615565477
Facility: Nasz Lekarz Przychodnie Medyczne ( Site 0679)
Torun, 30-510
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+41223727876
Facility: Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)
Tarnow, 08-110
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+886422052121 ext.4440
Facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
Siedlce, 02-798
Poland
Status: Recruiting Contact: Contact
Study Coordinator
886-4-2359-2525 ext.5124
Facility: Medical Concierge Centrum Medyczne ( Site 0676)
Warsaw, 01-748
Poland
Status: Recruiting Contact: Contact
Study Coordinator
886-2-28757519#306
Facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)
Przemysl, 83-400
Poland
Status: Recruiting Contact: Contact
Study Coordinator
0905337483275
Facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)
Slupsk, 44-200
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+905323430723
Facility: Clinical Research Center Sp. z o.o. ( Site 0674)
Poznan, 4710-243
Poland
Status: Recruiting Contact: Contact
Study Coordinator
+4401463706356
Facility: 2CA Braga. Centro Clinico Academico ( Site 0705)
Braga, 3000-075
Portugal
Status: Recruiting Contact: Contact
Study Coordinator
+442078828505
Facility: CHLN Hospital Santa Maria ( Site 0702)
Lisboa, 1998-018
Portugal
Status: Recruiting Contact: N/A
Facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)
Porto, 00716
Portugal
Status: Recruiting Contact: N/A
Facility: Advance Urology and Laparoscopic Center ( Site 0757)
Ponce, 00717
Puerto Rico
Status: Recruiting Contact: N/A
Facility: Ad-Vance Medical Research ( Site 0756)
Ponce, 27003
Puerto Rico
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Lucus Augusti ( Site 0852)
Lugo, 28223
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Quiron Madrid ( Site 0862)
Pozuelo de Alarcon, 31008
Spain
Status: Recruiting Contact: N/A
Facility: Fundacio Puigvert ( Site 0864)
Barcelona, 28007
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Gregorio Maranon ( Site 0854)
Madrid, 28027
Spain
Status: Recruiting Contact: N/A
Facility: MD Anderson Cancer Center Madrid ( Site 0859)
Madrid, 28034
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario Ramon y Cajal ( Site 0857)
Madrid, 28046
Spain
Status: Recruiting Contact: N/A
Facility: Hospital Universitario La Paz ( Site 0866)
Madrid, 46026
Spain
Status: Recruiting Contact: N/A
Facility: Hospital La Fe de Valencia ( Site 0855)
Valencia, 4031
Spain
Status: Recruiting Contact: N/A
Facility: Universitaetsspital Basel ( Site 1201)
Basel, 1205
Switzerland
Status: Recruiting Contact: N/A
Facility: Hopitaux Universitaires de Geneve HUG ( Site 1204)
Geneve, 8091
Switzerland
Status: Recruiting Contact: N/A
Facility: Universitaetsspital Zurich ( Site 1203)
Zurich, 40447
Switzerland
Status: Recruiting Contact: N/A
Facility: China Medical University Hospital-Department of Urology ( Site 1654)
Taichung, 407
Taiwan
Status: Recruiting Contact: N/A
Facility: Taichung Veterans General Hospital ( Site 1653)
Taichung, 11217
Taiwan
Status: Recruiting Contact: N/A
Facility: Taipei Veterans General Hospital ( Site 1652)
Taipei, 34385
Taiwan
Status: Recruiting Contact: N/A
Facility: Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)
Stanbul, 06590
Turkey
Status: Recruiting Contact: N/A
Facility: Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)
Ankara, 26480
Turkey
Status: Recruiting Contact: N/A
Facility: Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)
Eskisehir, 34722
Turkey
Status: Recruiting Contact: N/A
Facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)
Istanbul, 35340
Turkey
Status: Recruiting Contact: N/A
Facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)
Konya, IV2 3UJ
Turkey
Status: Recruiting Contact: N/A
Facility: Raigmore Hospital ( Site 1006)
Inverness, EC1A 7BE
United Kingdom
Status: Recruiting Contact: N/A
Facility: St Bartholomew s Hospital ( Site 1008)
London, SW17 0QT
United Kingdom
Status: Recruiting Contact: N/A
Facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1005)
London,
United Kingdom
Status: Recruiting Contact: N/A