Clinical trial NCT03711032: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: 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)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-10-18
Enrollment: 1397
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are looking for new ways to treat high-risk non muscle invasive bladder cancer (HR NMIBC). NMIBC is cancer in the tissue that lines the inside of the bladder but has not spread to the bladder muscle or outside of the bladder. High-risk means NMIBC may have a high chance of getting worse or coming back after treatment.

The goals of this study are to learn: 1. If more people who receive pembrolizumab with Bacillus Calmette-Guerin (BCG) have no signs of cancer in their body and live longer without the cancer growing, spreading, or coming back compared to people who receive BCG alone. 2. About the safety and how well people tolerate BCG alone or in combination with pembrolizumab.


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

Primary outcomes:
measure: Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
timeFrame: Up to ~3.5 years
measure: Event-Free Survival (EFS) (Cohort B)
timeFrame: Up to ~5 years
Secondary outcomes:
measure: EFS (Cohort A)
timeFrame: Up to ~5 years
measure: Recurrence-Free Survival (RFS) (Cohorts A and B)
timeFrame: Up to ~5 years
measure: Overall Survival (OS) (Cohorts A and B)
timeFrame: Up to ~5 years
measure: Disease Specific Survival (DSS) (Cohorts A and B)
timeFrame: Up to ~5 years
measure: Time to Cystectomy (Cohorts A and B)
timeFrame: Up to ~5 years
measure: 12-Month EFS Rate (Cohort A)
timeFrame: 12 months after EFS (up to ~5 years)
measure: Duration of Response (DOR) (Cohorts A and B)
timeFrame: Up to ~5 years
measure: 12-Month DOR Rate (Cohorts A and B)
timeFrame: 12 months after CR (up to ~4.5 years)
measure: Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B)
timeFrame: Up to ~5 years
measure: Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B)
timeFrame: Up to ~5 years
measure: 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)
timeFrame: Baseline, time of last PRO assessment (up to ~2 years)
measure: Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B)
timeFrame: Baseline, time of last PRO assessment (up to ~2 years)
measure: Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B)
timeFrame: Baseline, time of last PRO assessment (up to ~2 years)
measure: 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)
timeFrame: Baseline, time of last PRO assessment (up to ~2 years)
measure: 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)
timeFrame: Time of last PRO assessment (up to ~2 years)
measure: TTD in the EQ-5D-5L VAS (Cohorts A and B)
timeFrame: Time of last PRO assessment (up to ~2 years)
measure: CRR by BICR (Cohort B)
timeFrame: Up to ~3.5 years
measure: 24-Month EFS Rate (Cohort B)
timeFrame: 24 months after EFS (Up to ~5 years)
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)
state: Alaska
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix ( Site 1094)
state: Arizona
city: Tucson
country: United States
facility: Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
state: California
city: Orange
country: United States
facility: University of California Irvine Medical Center ( Site 1061)
state: California
city: Torrance
country: United States
facility: Genesis Research LLC ( Site 1065)
state: California
city: Lakewood
country: United States
facility: Colorado Clinical Research ( Site 1100)
state: Colorado
city: Hialeah
country: United States
facility: Urological Research Network ( Site 1106)
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida-Urology ( Site 1097)
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)
state: Florida
city: Pensacola
country: United States
facility: Woodlands Medical Specialists, PA ( Site 8002)
state: Florida
city: Atlanta
country: United States
facility: Emory School of Medicine ( Site 1076)
state: Georgia
city: Roswell
country: United States
facility: Advanced Urology ( Site 1092)
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital ( Site 1101)
state: Illinois
city: Wichita
country: United States
facility: Wichita Urology Group ( Site 1086)
state: Kansas
city: Shreveport
country: United States
facility: Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 1062)
state: Michigan
city: Troy
country: United States
facility: Michigan Institute of Urology ( Site 1077)
state: Michigan
city: Brick
country: United States
facility: Coastal Urology Associates ( Site 1055)
state: New Jersey
city: Morristown
country: United States
facility: Morristown Medical Center ( Site 1090)
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 1059)
state: New Jersey
city: Albany
country: United States
facility: St. Peter's Hospital Cancer Care Center ( Site 1087)
state: New York
city: Lake Success
country: United States
facility: R.J. Zuckerberg Cancer Center ( Site 1080)
state: New York
city: New York
country: United States
facility: Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)
state: New York
city: Syracuse
country: United States
facility: Associated Medical Professionals of NY ( Site 1078)
state: New York
city: Cincinnati
country: United States
facility: TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center ( Site 1066)
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10
state: Ohio
city: Portland
country: United States
facility: OHSU Knight Cancer Institute ( Site 1075)
state: Oregon
city: Springfield
country: United States
facility: Oregon Urology Institute ( Site 1098)
state: Oregon
city: Bala-Cynwyd
country: United States
facility: MidLantic Urology ( Site 1071)
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster Urology ( Site 1079)
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania ( Site 1088)
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center ( Site 1085)
state: South Carolina
city: Nashville
country: United States
facility: Urology Associates [Nashville, TN] ( Site 1072)
state: Tennessee
city: Dallas
country: United States
facility: Urology Clinics of North Texas, PLLC ( Site 1064)
state: Texas
city: Dallas
country: United States
facility: University Of Texas Southwestern Medical Center ( Site 1053)
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology-Fort Worth Cancer Center ( Site 8003)
state: Texas
city: Houston
country: United States
facility: Houston Metro Urology ( Site 1111)
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano West ( Site 8001)
state: Texas
city: San Antonio
country: United States
facility: Urology San Antonio Research ( Site 1108)
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center ( Site 1057)
state: Vermont
city: Virginia Beach
country: United States
facility: Urology of Virginia ( Site 1070)
state: Virginia
city: St Leonards
country: Australia
facility: GenesisCare North Shore ( Site 0010)
state: New South Wales
city: St Leonards
country: Australia
facility: Northern Cancer Institute. ( Site 0003)
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital ( Site 0001)
state: New South Wales
city: Richmond
country: Australia
facility: Epworth Hospital ( Site 0009)
state: Victoria
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)
state: Oberosterreich
city: Innsbruck
country: Austria
facility: Univ. Klinik f. Urologie Innsbruck ( Site 0051)
state: Tirol
city: Vienna
country: Austria
facility: Medizinische Universität Wien ( Site 0054)
state: Wien
city: Salzburg
country: Austria
facility: Universitaetsklinik Salzburg ( Site 0053)
city: Edegem
country: Belgium
facility: UZA University Hospital Antwerp ( Site 0105)
state: Antwerpen
city: Yvoir
country: Belgium
facility: CHU UCL Namur Site de Godinne ( Site 0103)
state: Namur
city: Aalst
country: Belgium
facility: O.L.V. Ziekenhuis Aalst ( Site 0106)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: AZ Maria Middelares Gent ( Site 0102)
state: Oost-Vlaanderen
city: Gent
country: Belgium
facility: UZ Gent ( Site 0101)
state: Oost-Vlaanderen
city: Fortaleza
country: Brazil
facility: Hospital São Carlos-Oncocentro Ce ( Site 1558)
state: Ceara
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)
state: Parana
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)
city: Sao Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)
city: Sao Paulo
country: Brazil
facility: Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)
city: Abbotsford
country: Canada
facility: Exdeo Clinical Research Inc. ( Site 0165)
state: British Columbia
city: Victoria
country: Canada
facility: Silverado Resarch Inc. ( Site 0155)
state: British Columbia
city: Moncton
country: Canada
facility: Horizon Health Network ( Site 0160)
state: New Brunswick
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0153)
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)
state: Quebec
city: Montreal
country: Canada
facility: CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS - Hopital Fleurimont ( Site 0152)
state: Quebec
city: Quebec
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital ( Site 1759)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-Urinary Surgery ( Site 1755)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 1784)
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated hospital of Xiamen University-Urology ( Site 1776)
state: Fujian
city: Guangzhou
country: China
facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)
state: Guangdong
city: Shenzhen
country: China
facility: ShenZhen People's Hospital ( Site 1778)
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital-urology ( Site 1772)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-Urology ( Site 1770)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 1771)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 1763)
state: Hunan
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
state: Jiangsu
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)
state: Jiangsu
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)
state: Shaanxi
city: Cheng Du
country: China
facility: West China Hospital Sichuan University ( Site 1767)
state: Sichuan
city: Tianjin
country: China
facility: The Second Hospital of Tianjin Medical University ( Site 1769)
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital-Urology ( Site 1762)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)
state: Zhejiang
city: Medellín
country: Colombia
facility: Instituto de Cancerología-Oncology ( Site 1609)
state: Antioquia
city: Rionegro
country: Colombia
facility: Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad
state: Antioquia
city: Montería
country: Colombia
facility: Oncomedica S.A.-Oncomedica S.A ( Site 1604)
state: Cordoba
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)
state: Distrito Capital De Bogota
city: Bogotá
country: Colombia
facility: Administradora Country S.A. - Clinica del Country ( Site 1607)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente ( Site 1608)
state: Risaralda
city: Cali
country: Colombia
facility: Hemato Oncologos SA-Oncology ( Site 1601)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: Clínica Imbanaco S.A.S ( Site 1611)
state: Valle Del Cauca
city: San José
country: Costa Rica
facility: CIMCA ( Site 1550)
state: San Jose
city: San Jose
country: Costa Rica
facility: Policlinico San Bosco ( Site 0600)
city: Tampere
country: Finland
facility: Tampere University Hospital [Tampere Finland] ( Site 0201)
state: Pirkanmaa
city: Dijon
country: France
facility: Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)
state: Bourgogne
city: Suresnes
country: France
facility: Hôpital Foch-Urology department ( Site 1351)
state: Hauts-de-Seine
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)
state: Ille-et-Vilaine
city: Lille
country: France
facility: Hopital Claude Huriez - CHU de Lille ( Site 1360)
state: Nord
city: Créteil
country: France
facility: HENRI MONDOR HOSPITAL ( Site 1357)
state: Seine-et-Marne
city: Munich
country: Germany
facility: Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)
state: Bayern
city: Weiden In Der Oberpfalz
country: Germany
facility: Klinikum Weiden ( Site 0259)
state: Bayern
city: Wuerzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg ( Site 0265)
state: Bayern
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)
state: Rheinland-Pfalz
city: Jena
country: Germany
facility: Universitaetsklinikum Jena ( Site 0252)
state: Thuringen
city: Patras
country: Greece
facility: Olympion General Clinic ( Site 0306)
state: Achaia
city: Patra
country: Greece
facility: General University Hospital of Patras ( Site 0302)
state: Achaia
city: Chaidari
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)
state: Attiki
city: Thessaloniki
country: Greece
facility: Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)
state: Kentriki Makedonia
city: Larissa
country: Greece
facility: University Hospital of Larissa ( Site 0301)
state: Thessalia
city: Guatemala City
country: Guatemala
facility: Onco Go, S.A ( Site 1454)
city: Guatemala
country: Guatemala
facility: INTEGRA Cancer Institute ( Site 1451)
city: Guatemala
country: Guatemala
facility: Grupo Medico Angeles ( Site 1453)
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)
state: Baranya
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)
state: Csongrad
city: Budapest
country: Hungary
facility: Semmelweis University-Urológiai Klinika ( Site 1301)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 1302)
city: Chieti
country: Italy
facility: Ospedale Clinicizzato Santissima Annunziata ( Site 0361)
state: Abruzzo
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)
state: Milano
city: Torino
country: Italy
facility: Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)
state: Piemonte
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi ( Site 0360)
state: Toscana
city: Bolzano
country: Italy
facility: Osp Generale Reg di Bolzano ( Site 0355)
state: Trentino-Sudtirol
city: Arezzo
country: Italy
facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II ( Site 0357)
city: Genova
country: Italy
facility: Ospedale San Martino ( Site 0351)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele ( Site 0362)
city: Palermo
country: Italy
facility: Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli ( Site 0358)
city: Verona
country: Italy
facility: A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital ( Site 0407)
state: Aomori
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 0414)
state: Ehime
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital ( Site 0412)
state: Ibaraki
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital ( Site 0415)
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital ( Site 0403)
state: Kanagawa
city: Yokosuka
country: Japan
facility: Yokosuka Kyosai Hospital ( Site 0406)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 0411)
state: Nara
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 0416)
state: Shizuoka
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0401)
city: Fukuoka
country: Japan
facility: Harasanshin Hospital ( Site 0410)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 0413)
city: Osaka
country: Japan
facility: Osaka Metropolitan University Hospital ( Site 0404)
city: Tokyo
country: Japan
facility: Institute of Science Tokyo Hospital ( Site 0409)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 0405)
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 0804)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital ( Site 0801)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 0802)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 0803)
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre ( Site 1180)
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre ( Site 0453)
state: Limburg
city: Rotterdam
country: Netherlands
facility: Erasmus MC ( Site 0451)
state: Zuid-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)
city: Lorenskog
country: Norway
facility: Akershus University Hospital ( Site 0553)
state: Akershus
city: Stavanger
country: Norway
facility: Stavanger universitetssykehus ( Site 0555)
state: Rogaland
city: La Victoria
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)
state: Lima
city: Lima
country: Peru
facility: Oncosalud ( Site 0603)
state: Muni Metro De Lima
city: Lima
country: Peru
facility: Hospital Militar Central [Lima, Peru] ( Site 0604)
city: Wroclaw
country: Poland
facility: Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)
state: Dolnoslaskie
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun ( Site 0679)
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Pratia MCM Krakow ( Site 0668)
state: Malopolskie
city: Tarnow
country: Poland
facility: Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)
state: Malopolskie
city: Siedlce
country: Poland
facility: Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
state: Mazowieckie
city: Warsaw
country: Poland
facility: Medical Concierge Centrum Medyczne ( Site 0676)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Luxmed Onkologia sp. z o. o. ( Site 0653)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)
state: Podkarpackie
city: Koscierzyna
country: Poland
facility: Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)
state: Pomorskie
city: Slupsk
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)
state: Pomorskie
city: Rybnik
country: Poland
facility: LIFTMED ( Site 0652)
state: Slaskie
city: Poznan
country: Poland
facility: Clinical Research Center Sp. z o.o. ( Site 0674)
state: Wielkopolskie
city: Lisbon
country: Portugal
facility: Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 0702)
state: Lisboa
city: Braga
country: Portugal
facility: Unidade Local de Saude de Braga - Hospital de Braga ( Site 0705)
city: Coimbra
country: Portugal
facility: Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)
city: Lisboa
country: Portugal
facility: Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas ( Site 0706)
city: Porto
country: Portugal
facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)
city: Ponce
country: Puerto Rico
facility: Advance Urology and Laparoscopic Center ( Site 0757)
city: Ponce
country: Puerto Rico
facility: Ad-Vance Medical Research ( Site 0756)
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti ( Site 0852)
state: La Coruna
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quiron Madrid ( Site 0862)
state: Madrid, Comunidad De
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra ( Site 0863)
state: Navarra
city: Barcelona
country: Spain
facility: Fundacio Puigvert ( Site 0864)
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Maranon ( Site 0854)
city: Madrid
country: Spain
facility: Clinica Universitaria Navarra - Madrid ( Site 0860)
city: Madrid
country: Spain
facility: MD Anderson Cancer Center Madrid ( Site 0859)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 0857)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 0866)
city: Valencia
country: Spain
facility: Hospital La Fe de Valencia ( Site 0855)
city: Basel
country: Switzerland
facility: Universitaetsspital Basel ( Site 1201)
state: Basel-Stadt
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve HUG ( Site 1204)
city: Zurich
country: Switzerland
facility: Universitaetsspital Zurich ( Site 1203)
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)
city: Eskisehir
country: Turkey
facility: Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)
city: Istanbul
country: Turkey
facility: Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)
city: Izmir
country: Turkey
facility: Dokuz Eylul Universitesi ( Site 0959)
city: Konya
country: Turkey
facility: Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)
city: Inverness
country: United Kingdom
facility: Raigmore Hospital ( Site 1006)
state: Highland
city: London
country: United Kingdom
facility: St Bartholomew s Hospital ( Site 1008)
state: London, City Of
city: London
country: United Kingdom
facility: St Georges University Hospitals NHS Foundation Trust. ( Site 1005)
state: London, City Of
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
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.