Back to resultsEfficacy 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)
Primary Purpose
High-risk Non-muscle Invasive Bladder Cancer
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pembrolizumab
BCG
Sponsored by
About this trial
This is an interventional treatment trial for High-risk Non-muscle Invasive Bladder Cancer focused on measuring programmed cell death receptor 1 (PD-1), programmed cell death ligand 1 (PD-L1), anti-PD-1, anti-PD-L1, BCG, HR NMIBC, Patient Reported Outcome (PRO)
Eligibility Criteria
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
Sites / Locations
- Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)
- Mayo Clinic in Arizona - Phoenix ( Site 1094)Recruiting
- Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)Recruiting
- UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
- University of California Irvine Medical Center ( Site 1061)Recruiting
- Genesis Research LLC ( Site 1065)Recruiting
- Colorado Clinical Research ( Site 1100)Recruiting
- Urological Research Network ( Site 1106)Recruiting
- Mayo Clinic in Florida-Urology ( Site 1097)Recruiting
- University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)Recruiting
- Woodlands Medical Specialists, PA ( Site 8002)
- Emory School of Medicine ( Site 1076)Recruiting
- Advanced Urology ( Site 1092)Recruiting
- Northwestern Memorial Hospital ( Site 1101)Recruiting
- Wichita Urology Group ( Site 1086)Recruiting
- Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)Recruiting
- Henry Ford Health System ( Site 1062)Recruiting
- Michigan Institute of Urology ( Site 1077)Recruiting
- Coastal Urology Associates ( Site 1055)
- Morristown Medical Center ( Site 1090)Recruiting
- Rutgers Cancer Institute of New Jersey ( Site 1059)
- St. Peter's Hospital Cancer Care Center ( Site 1087)
- Monter Cancer Center ( Site 1080)Recruiting
- Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)Recruiting
- Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)Recruiting
- Associated Medical Professionals of NY ( Site 1078)
- TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)Recruiting
- University Hospitals Cleveland Medical Center ( Site 1066)
- Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10Recruiting
- OHSU Knight Cancer Institute ( Site 1075)
- Oregon Urology Institute ( Site 1098)Recruiting
- MidLantic Urology ( Site 1071)Recruiting
- Lancaster Urology ( Site 1079)Recruiting
- University of Pennsylvania ( Site 1088)Recruiting
- Carolina Urologic Research Center ( Site 1085)Recruiting
- Urology Associates [Nashville, TN] ( Site 1072)Recruiting
- Urology Clinics of North Texas, PLLC ( Site 1064)Recruiting
- University Of Texas Southwestern Medical Center ( Site 1053)Recruiting
- Texas Oncology-Fort Worth Cancer Center ( Site 8003)
- Houston Metro Urology ( Site 1111)Recruiting
- Texas Oncology-Plano West ( Site 8001)
- Urology San Antonio Research ( Site 1108)Recruiting
- University of Vermont Medical Center ( Site 1057)Recruiting
- Urology of Virginia ( Site 1070)Recruiting
- GenesisCare North Shore ( Site 0010)Recruiting
- Nothern Cancer Institute ( Site 0003)
- Sydney Adventist Hospital ( Site 0001)
- Epworth Hospital ( Site 0009)Recruiting
- Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)Recruiting
- Univ. Klinik f. Urologie Innsbruck ( Site 0051)
- Medizinische Universität Wien ( Site 0054)Recruiting
- Universitaetsklinik Salzburg ( Site 0053)Recruiting
- UZA University Hospital Antwerp ( Site 0105)Recruiting
- CHU UCL Namur Site de Godinne ( Site 0103)Recruiting
- O.L.V. Ziekenhuis Aalst ( Site 0106)Recruiting
- AZ Maria Middelares Gent ( Site 0102)Recruiting
- UZ Gent ( Site 0101)Recruiting
- Hospital São Carlos-Oncocentro Ce ( Site 1558)
- Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)Recruiting
- Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)
- Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)
- BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)
- Exdeo Clinical Research Inc. ( Site 0165)
- Silverado Resarch Inc. ( Site 0155)
- Horizon Health Network ( Site 0160)Recruiting
- Princess Margaret Cancer Centre ( Site 0153)Recruiting
- CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)Recruiting
- CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)Recruiting
- CHUS - Hopital Fleurimont ( Site 0152)Recruiting
- Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0Recruiting
- Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)Recruiting
- Peking University First Hospital ( Site 1759)Recruiting
- Beijing Cancer hospital-Urinary Surgery ( Site 1755)Recruiting
- The First Affiliated hospital of Xiamen University-Urology ( Site 1776)Recruiting
- SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)Recruiting
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)Recruiting
- The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777)Recruiting
- ShenZhen People's Hospital ( Site 1778)Recruiting
- Harbin Medical University Cancer Hospital-urology ( Site 1772)Recruiting
- Henan Cancer Hospital-Urology ( Site 1770)Recruiting
- Wuhan Union Hospital ( Site 1771)Recruiting
- Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)Recruiting
- Hunan Cancer Hospital ( Site 1763)Recruiting
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( SRecruiting
- The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)Recruiting
- West China Hospital Sichuan University ( Site 1767)Recruiting
- The Second Hospital of Tianjin Medical University ( Site 1769)Recruiting
- Zhejiang Provincial People's Hospital-Urology ( Site 1762)Recruiting
- The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)Recruiting
- Instituto de Cancerología-Oncology ( Site 1609)
- Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad
- Oncomedica S.A.-Oncomedica S.A ( Site 1604)
- Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)
- Administradora Country S.A. - Clinica del Country ( Site 1607)
- Oncologos del Occidente ( Site 1608)
- Hemato Oncologos SA-Oncology ( Site 1601)
- Clínica Imbanaco S.A.S ( Site 1611)
- CIMCA ( Site 1550)Recruiting
- Policlinico San Bosco ( Site 0600)Recruiting
- Tampere University Hospital [Tampere Finland] ( Site 0201)
- Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)Recruiting
- Hôpital Foch-Urology department ( Site 1351)Recruiting
- Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)Recruiting
- Hopital Claude Huriez - CHU de Lille ( Site 1360)Recruiting
- HENRI MONDOR HOSPITAL ( Site 1357)Recruiting
- Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)Recruiting
- Klinikum Weiden ( Site 0259)Recruiting
- Universitaetsklinikum Wuerzburg ( Site 0265)Recruiting
- Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)Recruiting
- Universitaetsklinikum Jena ( Site 0252)Recruiting
- Olympion General Clinic ( Site 0306)Recruiting
- General University Hospital of Patras ( Site 0302)
- ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)Recruiting
- Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)
- University Hospital of Larissa ( Site 0301)Recruiting
- Onco Go, S.A ( Site 1454)
- INTEGRA Cancer Institute ( Site 1451)
- Grupo Medico Angeles-Grupo Medico Angeles ( Site 1453)
- Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)Recruiting
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)Recruiting
- Semmelweis University-Urológiai Klinika ( Site 1301)Recruiting
- Debreceni Egyetem Klinikai Kozpont ( Site 1302)Recruiting
- Ospedale Clinicizzato Santissima Annunziata ( Site 0361)Recruiting
- Ospedale San Raffaele ( Site 0362)Recruiting
- Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)Recruiting
- Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)Recruiting
- Azienda Ospedaliero Universitaria Careggi ( Site 0360)Recruiting
- Osp Generale Reg di Bolzano ( Site 0355)
- Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)Recruiting
- Istituto Tumori Giovanni Paolo II ( Site 0357)
- Ospedale San Martino ( Site 0351)
- Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)Recruiting
- Policlinico Universitario A. Gemelli ( Site 0358)Recruiting
- A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)
- Hirosaki University Hospital ( Site 0407)Recruiting
- Ehime University Hospital ( Site 0414)Recruiting
- University of Tsukuba Hospital ( Site 0412)Recruiting
- St. Marianna University Hospital ( Site 0415)Recruiting
- Kitasato University Hospital ( Site 0403)Recruiting
- Yokosuka Kyosai Hospital ( Site 0406)Recruiting
- Nara Medical University Hospital ( Site 0411)Recruiting
- Hamamatsu University Hospital ( Site 0416)Recruiting
- Chiba Cancer Center ( Site 0401)Recruiting
- Harasanshin Hospital ( Site 0410)Recruiting
- Osaka International Cancer Institute ( Site 0413)Recruiting
- Osaka Metropolitan University Hospital ( Site 0404)Recruiting
- Tokyo Medical and Dental University Hospital ( Site 0409)Recruiting
- Keio University Hospital ( Site 0405)Recruiting
- Asan Medical Center ( Site 0804)
- Korea University Anam Hospital ( Site 0801)Recruiting
- Seoul National University Hospital ( Site 0802)Recruiting
- Samsung Medical Center ( Site 0803)
- University Malaya Medical Centre ( Site 1180)
- Maastricht University Medical Centre ( Site 0453)Recruiting
- Erasmus MC ( Site 0451)Recruiting
- Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)
- Akershus University Hospital ( Site 0553)Recruiting
- Stavanger universitetssykehus ( Site 0555)Recruiting
- Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)
- Oncosalud ( Site 0603)Recruiting
- Hospital Militar Central [Lima, Peru] ( Site 0604)Recruiting
- Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)Recruiting
- Nasz Lekarz Przychodnie Medyczne ( Site 0679)Recruiting
- Pratia MCM Krakow ( Site 0668)
- Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)Recruiting
- Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
- Medical Concierge Centrum Medyczne ( Site 0676)Recruiting
- Luxmed Onkologia sp. z o. o. ( Site 0653)
- Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)Recruiting
- Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)
- Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)Recruiting
- LIFTMED ( Site 0652)
- Clinical Research Center Sp. z o.o. ( Site 0674)Recruiting
- 2CA Braga. Centro Clinico Academico ( Site 0705)Recruiting
- Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)
- Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)
- CHLN Hospital Santa Maria ( Site 0702)Recruiting
- Hospital CUF Descobertas ( Site 0706)
- Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)Recruiting
- Advance Urology and Laparoscopic Center ( Site 0757)
- Ad-Vance Medical Research ( Site 0756)
- Hospital Universitario Lucus Augusti ( Site 0852)Recruiting
- Hospital Universitario Quiron Madrid ( Site 0862)Recruiting
- Clinica Universitaria de Navarra ( Site 0863)
- Fundacio Puigvert ( Site 0864)Recruiting
- Hospital Universitario Gregorio Maranon ( Site 0854)Recruiting
- Clinica Universitaria Navarra - Madrid ( Site 0860)
- MD Anderson Cancer Center Madrid ( Site 0859)Recruiting
- Hospital Universitario Ramon y Cajal ( Site 0857)Recruiting
- Hospital Universitario La Paz ( Site 0866)Recruiting
- Hospital La Fe de Valencia ( Site 0855)Recruiting
- Universitaetsspital Basel ( Site 1201)Recruiting
- Hopitaux Universitaires de Geneve HUG ( Site 1204)Recruiting
- Universitaetsspital Zurich ( Site 1203)Recruiting
- China Medical University Hospital-Department of Urology ( Site 1654)
- Taichung Veterans General Hospital ( Site 1653)
- Taipei Veterans General Hospital ( Site 1652)
- Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)Recruiting
- Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)Recruiting
- Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)Recruiting
- TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)Recruiting
- Dokuz Eylul Universitesi ( Site 0959)
- Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)Recruiting
- Raigmore Hospital ( Site 1006)Recruiting
- St Bartholomew s Hospital ( Site 1008)Recruiting
- St Georges University Hospitals NHS Foundation Trust. ( Site 1005)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)
BCG Monotherapy: Post-induction Cohort A (Arm A-2)
BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)
BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)
BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)
Arm Description
Participants receive BCG (Induction and Maintenance) in combination with 200 mg pembrolizumab administered intravenously (IV) every 3 weeks (Q3W) for 35 doses (~2 years).
Participants receive BCG monotherapy (Induction and Maintenance).
Participants receive BCG (Induction and reduced Maintenance) in combination with 400 mg pembrolizumab administered IV every 6 weeks (Q6W) for 9 doses (~1 year).
Participants receive BCG (Induction and full Maintenance) in combination with 400 mg pembrolizumab administered IV Q6W for 9 doses (~1 year).
Participants receive BCG monotherapy (Induction and Maintenance).
Outcomes
Primary Outcome Measures
Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
CRR is defined as the percentage of participants with CIS achieving a complete response (CR).
Event-Free Survival (EFS) (Cohort B)
EFS is defined as the time from randomization until urothelial carcinoma (UC)-defined event, or death due to any cause.
Secondary Outcome Measures
EFS (Cohort A)
EFS is defined as the time from randomization until UC-defined event, or death due to any cause.
Recurrence-Free Survival (RFS) (Cohorts A and B)
RFS is defined as the time from randomization until the first occurrence of any UC recurrence, progression, or death due to any cause.
Overall Survival (OS) (Cohorts A and B)
OS is defined as the time from randomization to death due to any cause.
Disease Specific Survival (DSS) (Cohorts A and B)
DSS is defined as the time from randomization to death due to bladder cancer.
Time to Cystectomy (Cohorts A and B)
Time to cystectomy is defined as the time from a participant's randomization until the date of cystectomy.
12-Month EFS Rate (Cohort A)
EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 12-month EFS rate is defined as the percentage of participants with EFS at 12 months.
Duration of Response (DOR) (Cohorts A and B)
DOR is defined as the time from first documented CR until end of response or death due to any cause, whichever occurs first.
12-Month DOR Rate (Cohorts A and B)
The 12-month DOR Rate is defined as the percentage of participants with a CR of at least 12 months duration.
Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B)
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B)
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B)
The EORTC-QLQ-NMIBC24 is a 24-item questionnaire developed to supplement the EORTC QLQ-C30 in high-risk NMIBC patients. Each item is scored out of 4 total points (1=Not at All to 4=Very Much). All responses are transformed from 0 to 100, with a high score indicating more symptoms or problems. The change from baseline in EORTC-QLQ-NMIBC24 total score will be presented.
Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (Cohorts A and B)
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.
Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B)
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD in Global Health Status/Quality of Life is defined as the time from baseline to the first onset of a 10 point or greater decrease from baseline in the Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score, with or without subsequent confirmation.
TTD in the EQ-5D-5L VAS (Cohorts A and B)
The EQ-5D-5L VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD in EQ-5D-5L VAS is defined as the time from baseline to the first onset of a 7 point or greater decrease from baseline in EQ-5D-5L VAS, with or without subsequent confirmation, under a right-censoring rule.
CRR by BICR (Cohort B)
CRR is defined as the percentage of participants with CIS achieving a CR.
24-Month EFS Rate (Cohort B)
EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 24-month EFS rate is defined as the percentage of participants with EFS at 24 months.
Full Information
NCT ID
NCT03711032
First Posted
October 15, 2018
Last Updated
October 18, 2023
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT03711032
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)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 24, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
October 12, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-risk Non-muscle Invasive Bladder Cancer
Keywords
programmed cell death receptor 1 (PD-1), programmed cell death ligand 1 (PD-L1), anti-PD-1, anti-PD-L1, BCG, HR NMIBC, Patient Reported Outcome (PRO)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1405 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)
Arm Type
Experimental
Arm Description
Participants receive BCG (Induction and Maintenance) in combination with 200 mg pembrolizumab administered intravenously (IV) every 3 weeks (Q3W) for 35 doses (~2 years).
Arm Title
BCG Monotherapy: Post-induction Cohort A (Arm A-2)
Arm Type
Experimental
Arm Description
Participants receive BCG monotherapy (Induction and Maintenance).
Arm Title
BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)
Arm Type
Experimental
Arm Description
Participants receive BCG (Induction and reduced Maintenance) in combination with 400 mg pembrolizumab administered IV every 6 weeks (Q6W) for 9 doses (~1 year).
Arm Title
BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)
Arm Type
Experimental
Arm Description
Participants receive BCG (Induction and full Maintenance) in combination with 400 mg pembrolizumab administered IV Q6W for 9 doses (~1 year).
Arm Title
BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)
Arm Type
Experimental
Arm Description
Participants receive BCG monotherapy (Induction and Maintenance).
Intervention Type
Biological
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
KEYTRUDA®, MK-3475
Intervention Description
Pembrolizumab IV infusion of 200 mg Q3W for BCG Post-Induction Cohort (Cohort A), or IV infusion of 400 mg Q6W for BCG Naïve Cohort (Cohort B), according to randomization
Intervention Type
Biological
Intervention Name(s)
BCG
Other Intervention Name(s)
TICE® BCG, OncoTICE®
Intervention Description
BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
Primary Outcome Measure Information:
Title
Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
Description
CRR is defined as the percentage of participants with CIS achieving a complete response (CR).
Time Frame
Up to ~3.5 years
Title
Event-Free Survival (EFS) (Cohort B)
Description
EFS is defined as the time from randomization until urothelial carcinoma (UC)-defined event, or death due to any cause.
Time Frame
Up to ~5 years
Secondary Outcome Measure Information:
Title
EFS (Cohort A)
Description
EFS is defined as the time from randomization until UC-defined event, or death due to any cause.
Time Frame
Up to ~5 years
Title
Recurrence-Free Survival (RFS) (Cohorts A and B)
Description
RFS is defined as the time from randomization until the first occurrence of any UC recurrence, progression, or death due to any cause.
Time Frame
Up to ~5 years
Title
Overall Survival (OS) (Cohorts A and B)
Description
OS is defined as the time from randomization to death due to any cause.
Time Frame
Up to ~5 years
Title
Disease Specific Survival (DSS) (Cohorts A and B)
Description
DSS is defined as the time from randomization to death due to bladder cancer.
Time Frame
Up to ~5 years
Title
Time to Cystectomy (Cohorts A and B)
Description
Time to cystectomy is defined as the time from a participant's randomization until the date of cystectomy.
Time Frame
Up to ~5 years
Title
12-Month EFS Rate (Cohort A)
Description
EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 12-month EFS rate is defined as the percentage of participants with EFS at 12 months.
Time Frame
12 months after EFS (up to ~5 years)
Title
Duration of Response (DOR) (Cohorts A and B)
Description
DOR is defined as the time from first documented CR until end of response or death due to any cause, whichever occurs first.
Time Frame
Up to ~5 years
Title
12-Month DOR Rate (Cohorts A and B)
Description
The 12-month DOR Rate is defined as the percentage of participants with a CR of at least 12 months duration.
Time Frame
12 months after CR (up to ~4.5 years)
Title
Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B)
Description
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Time Frame
Up to ~5 years
Title
Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B)
Description
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Time Frame
Up to ~5 years
Title
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B)
Description
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
Time Frame
Baseline, time of last PRO assessment (up to ~2 years)
Title
Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B)
Description
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Time Frame
Baseline, time of last PRO assessment (up to ~2 years)
Title
Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B)
Description
The EORTC-QLQ-NMIBC24 is a 24-item questionnaire developed to supplement the EORTC QLQ-C30 in high-risk NMIBC patients. Each item is scored out of 4 total points (1=Not at All to 4=Very Much). All responses are transformed from 0 to 100, with a high score indicating more symptoms or problems. The change from baseline in EORTC-QLQ-NMIBC24 total score will be presented.
Time Frame
Baseline, time of last PRO assessment (up to ~2 years)
Title
Change from Baseline in European Quality of Life (EuroQoL)-5 Dimensions, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Score (VAS) (Cohorts A and B)
Description
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.
Time Frame
Baseline, time of last PRO assessment (up to ~2 years)
Title
Time to Deterioration (TTD) in the EORTC-QLQ-C30 Global Health Status/Quality of Life (Items 29 and 30) Combined Score (Cohorts A and B)
Description
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD in Global Health Status/Quality of Life is defined as the time from baseline to the first onset of a 10 point or greater decrease from baseline in the Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score, with or without subsequent confirmation.
Time Frame
Time of last PRO assessment (up to ~2 years)
Title
TTD in the EQ-5D-5L VAS (Cohorts A and B)
Description
The EQ-5D-5L VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD in EQ-5D-5L VAS is defined as the time from baseline to the first onset of a 7 point or greater decrease from baseline in EQ-5D-5L VAS, with or without subsequent confirmation, under a right-censoring rule.
Time Frame
Time of last PRO assessment (up to ~2 years)
Title
CRR by BICR (Cohort B)
Description
CRR is defined as the percentage of participants with CIS achieving a CR.
Time Frame
Up to ~3.5 years
Title
24-Month EFS Rate (Cohort B)
Description
EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 24-month EFS rate is defined as the percentage of participants with EFS at 24 months.
Time Frame
24 months after EFS (Up to ~5 years)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toll Free Number
Phone
1-888-577-8839
Email
Trialsites@merck.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
Facility Information:
Facility Name
Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99503
Country
United States
Individual Site Status
Completed
Facility Name
Mayo Clinic in Arizona - Phoenix ( Site 1094)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
480-342-6672
Facility Name
Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
520-618-1010
Facility Name
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Completed
Facility Name
University of California Irvine Medical Center ( Site 1061)
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
714-456-8148
Facility Name
Genesis Research LLC ( Site 1065)
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
310-602-5005
Facility Name
Colorado Clinical Research ( Site 1100)
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
303-996-9649
Facility Name
Urological Research Network ( Site 1106)
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
786-431-2014
Facility Name
Mayo Clinic in Florida-Urology ( Site 1097)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
904-953-7330
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
305-243-2177
Facility Name
Woodlands Medical Specialists, PA ( Site 8002)
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Individual Site Status
Completed
Facility Name
Emory School of Medicine ( Site 1076)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
404-778-4823
Facility Name
Advanced Urology ( Site 1092)
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
678-344-8900
Facility Name
Northwestern Memorial Hospital ( Site 1101)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
312-695-4484
Facility Name
Wichita Urology Group ( Site 1086)
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
316-636-6141
Facility Name
Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
318-683-0411
Facility Name
Henry Ford Health System ( Site 1062)
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
313-916-8862
Facility Name
Michigan Institute of Urology ( Site 1077)
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
248-786-0467
Facility Name
Coastal Urology Associates ( Site 1055)
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Individual Site Status
Completed
Facility Name
Morristown Medical Center ( Site 1090)
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
973-971-5373
Facility Name
Rutgers Cancer Institute of New Jersey ( Site 1059)
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
St. Peter's Hospital Cancer Care Center ( Site 1087)
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Individual Site Status
Completed
Facility Name
Monter Cancer Center ( Site 1080)
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
516-734-8500
Facility Name
Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
2126867500 ext.6383
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
646-501-8206
Facility Name
Associated Medical Professionals of NY ( Site 1078)
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Individual Site Status
Completed
Facility Name
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
513-841-7555
Facility Name
University Hospitals Cleveland Medical Center ( Site 1066)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Completed
Facility Name
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
614-366-7421
Facility Name
OHSU Knight Cancer Institute ( Site 1075)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Individual Site Status
Completed
Facility Name
Oregon Urology Institute ( Site 1098)
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
541-284-5508
Facility Name
MidLantic Urology ( Site 1071)
City
Bala-Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
610-667-0458
Facility Name
Lancaster Urology ( Site 1079)
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
717-431-2285
Facility Name
University of Pennsylvania ( Site 1088)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
215-662-2891
Facility Name
Carolina Urologic Research Center ( Site 1085)
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8434491010257
Facility Name
Urology Associates [Nashville, TN] ( Site 1072)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
615-250-9268
Facility Name
Urology Clinics of North Texas, PLLC ( Site 1064)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-580-1485
Facility Name
University Of Texas Southwestern Medical Center ( Site 1053)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
214-645-8787
Facility Name
Texas Oncology-Fort Worth Cancer Center ( Site 8003)
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Completed
Facility Name
Houston Metro Urology ( Site 1111)
City
Houston
State/Province
Texas
ZIP/Postal Code
77027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
832-549-4395
Facility Name
Texas Oncology-Plano West ( Site 8001)
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Completed
Facility Name
Urology San Antonio Research ( Site 1108)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
832-472-5482
Facility Name
University of Vermont Medical Center ( Site 1057)
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
802-656-9926
Facility Name
Urology of Virginia ( Site 1070)
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
757-452-3463
Facility Name
GenesisCare North Shore ( Site 0010)
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
61294631172
Facility Name
Nothern Cancer Institute ( Site 0003)
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Completed
Facility Name
Sydney Adventist Hospital ( Site 0001)
City
Wahroonga
State/Province
New South Wales
ZIP/Postal Code
2076
Country
Australia
Individual Site Status
Completed
Facility Name
Epworth Hospital ( Site 0009)
City
Richmond
State/Province
Victoria
ZIP/Postal Code
3121
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0390085443
Facility Name
Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)
City
Linz
State/Province
Oberosterreich
ZIP/Postal Code
4020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4373276777727
Facility Name
Univ. Klinik f. Urologie Innsbruck ( Site 0051)
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Completed
Facility Name
Medizinische Universität Wien ( Site 0054)
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4367761942300
Facility Name
Universitaetsklinik Salzburg ( Site 0053)
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+435725527400
Facility Name
UZA University Hospital Antwerp ( Site 0105)
City
Edegem
State/Province
Antwerpen
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3238213718
Facility Name
CHU UCL Namur Site de Godinne ( Site 0103)
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3281423858
Facility Name
O.L.V. Ziekenhuis Aalst ( Site 0106)
City
Aalst
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9300
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3253724378
Facility Name
AZ Maria Middelares Gent ( Site 0102)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3292469522
Facility Name
UZ Gent ( Site 0101)
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+3293322811
Facility Name
Hospital São Carlos-Oncocentro Ce ( Site 1558)
City
Fortaleza
State/Province
Ceara
ZIP/Postal Code
60135-237
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)
City
Curitiba
State/Province
Parana
ZIP/Postal Code
81520-060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+554133615195
Facility Name
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784400
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Completed
Facility Name
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
04014-002
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Active, not recruiting
Facility Name
Exdeo Clinical Research Inc. ( Site 0165)
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2T 1X8
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Silverado Resarch Inc. ( Site 0155)
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 2C1
Country
Canada
Individual Site Status
Completed
Facility Name
Horizon Health Network ( Site 0160)
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5068574780
Facility Name
Princess Margaret Cancer Centre ( Site 0153)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4169462246
Facility Name
CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
4185411000
Facility Name
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
5142523400x5766
Facility Name
CHUS - Hopital Fleurimont ( Site 0152)
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8193461110x12827
Facility Name
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
418525444420414
Facility Name
Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18601238866
Facility Name
Peking University First Hospital ( Site 1759)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613910688432
Facility Name
Beijing Cancer hospital-Urinary Surgery ( Site 1755)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13910571565
Facility Name
The First Affiliated hospital of Xiamen University-Urology ( Site 1776)
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
8613806089889
Facility Name
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-87343392
Facility Name
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
020-81332371
Facility Name
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777)
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
(8620) 34294311
Facility Name
ShenZhen People's Hospital ( Site 1778)
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0755-25533018
Facility Name
Harbin Medical University Cancer Hospital-urology ( Site 1772)
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8613603612355
Facility Name
Henan Cancer Hospital-Urology ( Site 1770)
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8615981828716
Facility Name
Wuhan Union Hospital ( Site 1771)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18602752025
Facility Name
Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13367255851
Facility Name
Hunan Cancer Hospital ( Site 1763)
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 13207139095
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+8602583106666
Facility Name
The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
18994392817
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+86 18149480558
Facility Name
West China Hospital Sichuan University ( Site 1767)
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
（028）85164161
Facility Name
The Second Hospital of Tianjin Medical University ( Site 1769)
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300211
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
13662096232
Facility Name
Zhejiang Provincial People's Hospital-Urology ( Site 1762)
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0571-85893008
Facility Name
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0577-55579590
Facility Name
Instituto de Cancerología-Oncology ( Site 1609)
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
050024
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad
City
Rionegro
State/Province
Antioquia
ZIP/Postal Code
054047
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Oncomedica S.A.-Oncomedica S.A ( Site 1604)
City
Montería
State/Province
Cordoba
ZIP/Postal Code
230001
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)
City
Bogota
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
111321
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Administradora Country S.A. - Clinica del Country ( Site 1607)
City
Bogotá
State/Province
Distrito Capital De Bogota
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Oncologos del Occidente ( Site 1608)
City
Pereira
State/Province
Risaralda
ZIP/Postal Code
660001
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
Hemato Oncologos SA-Oncology ( Site 1601)
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
76001
Country
Colombia
Individual Site Status
Completed
Facility Name
Clínica Imbanaco S.A.S ( Site 1611)
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Individual Site Status
Active, not recruiting
Facility Name
CIMCA ( Site 1550)
City
San José
State/Province
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50683893636
Facility Name
Policlinico San Bosco ( Site 0600)
City
San Jose
ZIP/Postal Code
10103
Country
Costa Rica
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+50683384787
Facility Name
Tampere University Hospital [Tampere Finland] ( Site 0201)
City
Tampere
State/Province
Pirkanmaa
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)
City
Dijon
State/Province
Bourgogne
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33380293761
Facility Name
Hôpital Foch-Urology department ( Site 1351)
City
Suresnes
State/Province
Hauts-de-Seine
ZIP/Postal Code
92150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33146251961
Facility Name
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)
City
Rennes
State/Province
Ille-et-Vilaine
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
33299284270
Facility Name
Hopital Claude Huriez - CHU de Lille ( Site 1360)
City
Lille
State/Province
Nord
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0320444398
Facility Name
HENRI MONDOR HOSPITAL ( Site 1357)
City
Créteil
State/Province
Seine-et-Marne
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+33145178243
Facility Name
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)
City
Munich
State/Province
Bayern
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+498941402522
Facility Name
Klinikum Weiden ( Site 0259)
City
Weiden In Der Oberpfalz
State/Province
Bayern
ZIP/Postal Code
92637
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49963033302
Facility Name
Universitaetsklinikum Wuerzburg ( Site 0265)
City
Wuerzburg
State/Province
Bayern
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4993120132037
Facility Name
Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)
City
Trier
State/Province
Rheinland-Pfalz
ZIP/Postal Code
54292
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+496512082680
Facility Name
Universitaetsklinikum Jena ( Site 0252)
City
Jena
State/Province
Thuringen
ZIP/Postal Code
07747
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+49-3641-9-329901
Facility Name
Olympion General Clinic ( Site 0306)
City
Patras
State/Province
Achaia
ZIP/Postal Code
264 43
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302610464064
Facility Name
General University Hospital of Patras ( Site 0302)
City
Patra
State/Province
Achaia
ZIP/Postal Code
265 04
Country
Greece
Individual Site Status
Completed
Facility Name
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)
City
Chaidari
State/Province
Attiki
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302105831255
Facility Name
Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)
City
Thessaloniki
State/Province
Kentriki Makedonia
ZIP/Postal Code
54007
Country
Greece
Individual Site Status
Completed
Facility Name
University Hospital of Larissa ( Site 0301)
City
Larissa
State/Province
Thessalia
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+302413502811
Facility Name
Onco Go, S.A ( Site 1454)
City
Guatemala City
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
INTEGRA Cancer Institute ( Site 1451)
City
Guatemala
ZIP/Postal Code
01010
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Grupo Medico Angeles-Grupo Medico Angeles ( Site 1453)
City
Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Individual Site Status
Active, not recruiting
Facility Name
Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)
City
Pécs
State/Province
Baranya
ZIP/Postal Code
7621
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
3672507323
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)
City
Szeged
State/Province
Csongrad
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36709411312
Facility Name
Semmelweis University-Urológiai Klinika ( Site 1301)
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36208258762
Facility Name
Debreceni Egyetem Klinikai Kozpont ( Site 1302)
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+36308544051
Facility Name
Ospedale Clinicizzato Santissima Annunziata ( Site 0361)
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390871357783
Facility Name
Ospedale San Raffaele ( Site 0362)
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39022643789
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)
City
Milan
State/Province
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390223902402
Facility Name
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39 0115082032
Facility Name
Azienda Ospedaliero Universitaria Careggi ( Site 0360)
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390557949920
Facility Name
Osp Generale Reg di Bolzano ( Site 0355)
City
Bolzano
State/Province
Trentino-Sudtirol
ZIP/Postal Code
39100
Country
Italy
Individual Site Status
Completed
Facility Name
Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390575255436
Facility Name
Istituto Tumori Giovanni Paolo II ( Site 0357)
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Completed
Facility Name
Ospedale San Martino ( Site 0351)
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Completed
Facility Name
Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)
City
Palermo
ZIP/Postal Code
90123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+39091479432
Facility Name
Policlinico Universitario A. Gemelli ( Site 0358)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+390630154953
Facility Name
A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Completed
Facility Name
Hirosaki University Hospital ( Site 0407)
City
Hirosaki
State/Province
Aomori
ZIP/Postal Code
036-8563
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81172335111
Facility Name
Ehime University Hospital ( Site 0414)
City
Toon
State/Province
Ehime
ZIP/Postal Code
791-0295
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81899645111
Facility Name
University of Tsukuba Hospital ( Site 0412)
City
Tsukuba
State/Province
Ibaraki
ZIP/Postal Code
305-8576
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81298533900
Facility Name
St. Marianna University Hospital ( Site 0415)
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-44-977-8111
Facility Name
Kitasato University Hospital ( Site 0403)
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81427788111
Facility Name
Yokosuka Kyosai Hospital ( Site 0406)
City
Yokosuka
State/Province
Kanagawa
ZIP/Postal Code
238-8558
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81468222710
Facility Name
Nara Medical University Hospital ( Site 0411)
City
Kashihara
State/Province
Nara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81744223051
Facility Name
Hamamatsu University Hospital ( Site 0416)
City
Hamamatsu
State/Province
Shizuoka
ZIP/Postal Code
431-3192
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81-53-435-2111
Facility Name
Chiba Cancer Center ( Site 0401)
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81432645431
Facility Name
Harasanshin Hospital ( Site 0410)
City
Fukuoka
ZIP/Postal Code
812-0033
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81922913434
Facility Name
Osaka International Cancer Institute ( Site 0413)
City
Osaka
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81669451181
Facility Name
Osaka Metropolitan University Hospital ( Site 0404)
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81666452121
Facility Name
Tokyo Medical and Dental University Hospital ( Site 0409)
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81338136111
Facility Name
Keio University Hospital ( Site 0405)
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+81333531211
Facility Name
Asan Medical Center ( Site 0804)
City
Songpagu
State/Province
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Korea University Anam Hospital ( Site 0801)
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+821099288097
Facility Name
Seoul National University Hospital ( Site 0802)
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+82220720361
Facility Name
Samsung Medical Center ( Site 0803)
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
University Malaya Medical Centre ( Site 1180)
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Completed
Facility Name
Maastricht University Medical Centre ( Site 0453)
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31433876543
Facility Name
Erasmus MC ( Site 0451)
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+31107040704
Facility Name
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Individual Site Status
Completed
Facility Name
Akershus University Hospital ( Site 0553)
City
Lorenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4767960000
Facility Name
Stavanger universitetssykehus ( Site 0555)
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4011
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4751518000
Facility Name
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)
City
La Victoria
State/Province
Lima
ZIP/Postal Code
15033
Country
Peru
Individual Site Status
Completed
Facility Name
Oncosalud ( Site 0603)
City
Lima
State/Province
Muni Metro De Lima
ZIP/Postal Code
15036
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51992756559
Facility Name
Hospital Militar Central [Lima, Peru] ( Site 0604)
City
Lima
ZIP/Postal Code
15076
Country
Peru
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+51997468543
Facility Name
Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)
City
Wroclaw
State/Province
Dolnoslaskie
ZIP/Postal Code
50-556
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48601143281
Facility Name
Nasz Lekarz Przychodnie Medyczne ( Site 0679)
City
Torun
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48563004380
Facility Name
Pratia MCM Krakow ( Site 0668)
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Completed
Facility Name
Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)
City
Tarnow
State/Province
Malopolskie
ZIP/Postal Code
33-100
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48728355694
Facility Name
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
City
Siedlce
State/Province
Mazowieckie
ZIP/Postal Code
08-110
Country
Poland
Individual Site Status
Completed
Facility Name
Medical Concierge Centrum Medyczne ( Site 0676)
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-798
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48224166500
Facility Name
Luxmed Onkologia sp. z o. o. ( Site 0653)
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-748
Country
Poland
Individual Site Status
Completed
Facility Name
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)
City
Przemysl
State/Province
Podkarpackie
ZIP/Postal Code
37-700
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48661957237
Facility Name
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)
City
Koscierzyna
State/Province
Pomorskie
ZIP/Postal Code
83-400
Country
Poland
Individual Site Status
Completed
Facility Name
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)
City
Slupsk
State/Province
Pomorskie
ZIP/Postal Code
76-200
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48598460340
Facility Name
LIFTMED ( Site 0652)
City
Rybnik
State/Province
Slaskie
ZIP/Postal Code
44-200
Country
Poland
Individual Site Status
Completed
Facility Name
Clinical Research Center Sp. z o.o. ( Site 0674)
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+48616632513
Facility Name
2CA Braga. Centro Clinico Academico ( Site 0705)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351253027249
Facility Name
Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Individual Site Status
Completed
Facility Name
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Individual Site Status
Completed
Facility Name
CHLN Hospital Santa Maria ( Site 0702)
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351217805056
Facility Name
Hospital CUF Descobertas ( Site 0706)
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Completed
Facility Name
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+351225084000
Facility Name
Advance Urology and Laparoscopic Center ( Site 0757)
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
Individual Site Status
Active, not recruiting
Facility Name
Ad-Vance Medical Research ( Site 0756)
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Individual Site Status
Active, not recruiting
Facility Name
Hospital Universitario Lucus Augusti ( Site 0852)
City
Lugo
State/Province
La Coruna
ZIP/Postal Code
27003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34982296459
Facility Name
Hospital Universitario Quiron Madrid ( Site 0862)
City
Pozuelo de Alarcon
State/Province
Madrid, Comunidad De
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914521987
Facility Name
Clinica Universitaria de Navarra ( Site 0863)
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Completed
Facility Name
Fundacio Puigvert ( Site 0864)
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34934169700
Facility Name
Hospital Universitario Gregorio Maranon ( Site 0854)
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34914269070
Facility Name
Clinica Universitaria Navarra - Madrid ( Site 0860)
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Completed
Facility Name
MD Anderson Cancer Center Madrid ( Site 0859)
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34917878600
Facility Name
Hospital Universitario Ramon y Cajal ( Site 0857)
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34913368263
Facility Name
Hospital Universitario La Paz ( Site 0866)
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34 912 071 876
Facility Name
Hospital La Fe de Valencia ( Site 0855)
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+34961244188
Facility Name
Universitaetsspital Basel ( Site 1201)
City
Basel
State/Province
Basel-Stadt
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+41615565477
Facility Name
Hopitaux Universitaires de Geneve HUG ( Site 1204)
City
Geneve
ZIP/Postal Code
1205
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+41223727876
Facility Name
Universitaetsspital Zurich ( Site 1203)
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+41442555440
Facility Name
China Medical University Hospital-Department of Urology ( Site 1654)
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Taichung Veterans General Hospital ( Site 1653)
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Taipei Veterans General Hospital ( Site 1652)
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Active, not recruiting
Facility Name
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)
City
Ankara
ZIP/Postal Code
06590
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
0905337483275
Facility Name
Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)
City
Eskisehir
ZIP/Postal Code
26480
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905327149696
Facility Name
Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)
City
Istanbul
ZIP/Postal Code
34385
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905325755400
Facility Name
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)
City
Istanbul
ZIP/Postal Code
34722
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905323430723
Facility Name
Dokuz Eylul Universitesi ( Site 0959)
City
Izmir
ZIP/Postal Code
35340
Country
Turkey
Individual Site Status
Active, not recruiting
Facility Name
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)
City
Konya
ZIP/Postal Code
42000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+905322679838
Facility Name
Raigmore Hospital ( Site 1006)
City
Inverness
State/Province
Highland
ZIP/Postal Code
IV2 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+4401463706356
Facility Name
St Bartholomew s Hospital ( Site 1008)
City
London
State/Province
London, City Of
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442078828505
Facility Name
St Georges University Hospitals NHS Foundation Trust. ( Site 1005)
City
London
State/Province
London, City Of
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
+442087253362
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
IPD Sharing URL
http://engagezone.msd.com/ds_documentation.php
Citations:
PubMed Identifier
32162533
Citation
Kamat AM, Shore N, Hahn N, Alanee S, Nishiyama H, Shariat S, Nam K, Kapadia E, Frenkl T, Steinberg G. KEYNOTE-676: Phase III study of BCG and pembrolizumab for persistent/recurrent high-risk NMIBC. Future Oncol. 2020 Apr;16(10):507-516. doi: 10.2217/fon-2019-0817. Epub 2020 Mar 12.
Results Reference
derived
Links:
URL
http://merckclinicaltrials.com
Description
Merck Clinical Trials Information
URL
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475-676&kw=3475-676
Description
Plain Language Summary
Learn more about this trial
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)
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