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)

NCT ID: NCT03711032

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1397 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-24

Study Completion Date

2034-11-20

Brief Summary

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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.

Detailed Description

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Conditions

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High-risk Non-muscle Invasive Bladder Cancer

Keywords

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)

Participants receive BCG (Induction and Maintenance) in combination with 200 mg pembrolizumab administered intravenously (IV) every 3 weeks (Q3W) for 35 doses (\~2 years).

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

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

BCG

Intervention Type BIOLOGICAL

BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

BCG Monotherapy: Post-induction Cohort A (Arm A-2)

Participants receive BCG monotherapy (Induction and Maintenance).

Group Type EXPERIMENTAL

BCG

Intervention Type BIOLOGICAL

BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)

Participants receive BCG (Induction and reduced Maintenance) in combination with 400 mg pembrolizumab administered IV every 6 weeks (Q6W) for 9 doses (\~1 year).

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

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

BCG

Intervention Type BIOLOGICAL

BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)

Participants receive BCG (Induction and full Maintenance) in combination with 400 mg pembrolizumab administered IV Q6W for 9 doses (\~1 year).

Group Type EXPERIMENTAL

Pembrolizumab

Intervention Type BIOLOGICAL

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

BCG

Intervention Type BIOLOGICAL

BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)

Participants receive BCG monotherapy (Induction and Maintenance).

Group Type EXPERIMENTAL

BCG

Intervention Type BIOLOGICAL

BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

Interventions

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Pembrolizumab

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

BCG

BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy

Intervention Type BIOLOGICAL

Other Intervention Names

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KEYTRUDA® MK-3475 TICE® BCG OncoTICE®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)

Anchorage, Alaska, United States

Site Status

Mayo Clinic in Arizona - Phoenix ( Site 1094)

Phoenix, Arizona, United States

Site Status

Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)

Tucson, Arizona, United States

Site Status

UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro

Los Angeles, California, United States

Site Status

University of California Irvine Medical Center ( Site 1061)

Orange, California, United States

Site Status

Genesis Research LLC ( Site 1065)

Torrance, California, United States

Site Status

Colorado Clinical Research ( Site 1100)

Lakewood, Colorado, United States

Site Status

Urological Research Network ( Site 1106)

Hialeah, Florida, United States

Site Status

Mayo Clinic in Florida-Urology ( Site 1097)

Jacksonville, Florida, United States

Site Status

University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)

Miami, Florida, United States

Site Status

Woodlands Medical Specialists, PA ( Site 8002)

Pensacola, Florida, United States

Site Status

Emory School of Medicine ( Site 1076)

Atlanta, Georgia, United States

Site Status

Advanced Urology ( Site 1092)

Roswell, Georgia, United States

Site Status

Northwestern Memorial Hospital ( Site 1101)

Chicago, Illinois, United States

Site Status

Wichita Urology Group ( Site 1086)

Wichita, Kansas, United States

Site Status

Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)

Shreveport, Louisiana, United States

Site Status

Henry Ford Health System ( Site 1062)

Detroit, Michigan, United States

Site Status

Michigan Institute of Urology ( Site 1077)

Troy, Michigan, United States

Site Status

Coastal Urology Associates ( Site 1055)

Brick, New Jersey, United States

Site Status

Morristown Medical Center ( Site 1090)

Morristown, New Jersey, United States

Site Status

Rutgers Cancer Institute of New Jersey ( Site 1059)

New Brunswick, New Jersey, United States

Site Status

St. Peter's Hospital Cancer Care Center ( Site 1087)

Albany, New York, United States

Site Status

R.J. Zuckerberg Cancer Center ( Site 1080)

Lake Success, New York, United States

Site Status

Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)

New York, New York, United States

Site Status

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)

New York, New York, United States

Site Status

Associated Medical Professionals of NY ( Site 1078)

Syracuse, New York, United States

Site Status

TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)

Cincinnati, Ohio, United States

Site Status

University Hospitals Cleveland Medical Center ( Site 1066)

Cleveland, Ohio, United States

Site Status

Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10

Columbus, Ohio, United States

Site Status

OHSU Knight Cancer Institute ( Site 1075)

Portland, Oregon, United States

Site Status

Oregon Urology Institute ( Site 1098)

Springfield, Oregon, United States

Site Status

MidLantic Urology ( Site 1071)

Bala-Cynwyd, Pennsylvania, United States

Site Status

Lancaster Urology ( Site 1079)

Lancaster, Pennsylvania, United States

Site Status

University of Pennsylvania ( Site 1088)

Philadelphia, Pennsylvania, United States

Site Status

Carolina Urologic Research Center ( Site 1085)

Myrtle Beach, South Carolina, United States

Site Status

Urology Associates [Nashville, TN] ( Site 1072)

Nashville, Tennessee, United States

Site Status

Urology Clinics of North Texas, PLLC ( Site 1064)

Dallas, Texas, United States

Site Status

University Of Texas Southwestern Medical Center ( Site 1053)

Dallas, Texas, United States

Site Status

Texas Oncology-Fort Worth Cancer Center ( Site 8003)

Fort Worth, Texas, United States

Site Status

Houston Metro Urology ( Site 1111)

Houston, Texas, United States

Site Status

Texas Oncology-Plano West ( Site 8001)

Plano, Texas, United States

Site Status

Urology San Antonio Research ( Site 1108)

San Antonio, Texas, United States

Site Status

University of Vermont Medical Center ( Site 1057)

Burlington, Vermont, United States

Site Status

Urology of Virginia ( Site 1070)

Virginia Beach, Virginia, United States

Site Status

GenesisCare North Shore ( Site 0010)

St Leonards, New South Wales, Australia

Site Status

Northern Cancer Institute. ( Site 0003)

St Leonards, New South Wales, Australia

Site Status

Sydney Adventist Hospital ( Site 0001)

Wahroonga, New South Wales, Australia

Site Status

Epworth Hospital ( Site 0009)

Richmond, Victoria, Australia

Site Status

Univ. Klinik f. Urologie Innsbruck ( Site 0051)

Innsbruck, Tyrol, Austria

Site Status

Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)

Linz, Upper Austria, Austria

Site Status

Medizinische Universität Wien ( Site 0054)

Vienna, Vienna, Austria

Site Status

Universitaetsklinik Salzburg ( Site 0053)

Salzburg, , Austria

Site Status

UZA University Hospital Antwerp ( Site 0105)

Edegem, Antwerpen, Belgium

Site Status

CHU UCL Namur Site de Godinne ( Site 0103)

Yvoir, Namur, Belgium

Site Status

O.L.V. Ziekenhuis Aalst ( Site 0106)

Aalst, Oost-Vlaanderen, Belgium

Site Status

AZ Maria Middelares Gent ( Site 0102)

Ghent, Oost-Vlaanderen, Belgium

Site Status

UZ Gent ( Site 0101)

Ghent, Oost-Vlaanderen, Belgium

Site Status

Hospital São Carlos-Oncocentro Ce ( Site 1558)

Fortaleza, Ceará, Brazil

Site Status

Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)

Curitiba, Paraná, Brazil

Site Status

Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)

Barretos, São Paulo, Brazil

Site Status

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)

São Paulo, , Brazil

Site Status

BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)

São Paulo, , Brazil

Site Status

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)

São Paulo, , Brazil

Site Status

Exdeo Clinical Research Inc. ( Site 0165)

Abbotsford, British Columbia, Canada

Site Status

Silverado Resarch Inc. ( Site 0155)

Victoria, British Columbia, Canada

Site Status

Horizon Health Network ( Site 0160)

Moncton, New Brunswick, Canada

Site Status

Princess Margaret Cancer Centre ( Site 0153)

Toronto, Ontario, Canada

Site Status

CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)

Chicoutimi, Quebec, Canada

Site Status

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)

Montreal, Quebec, Canada

Site Status

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0

Québec, Quebec, Canada

Site Status

CHUS - Hopital Fleurimont ( Site 0152)

Sherbrooke, Quebec, Canada

Site Status

Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)

Beijing, Beijing Municipality, China

Site Status

Peking University First Hospital ( Site 1759)

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer hospital-Urinary Surgery ( Site 1755)

Beijing, Beijing Municipality, China

Site Status

Chongqing University Cancer Hospital ( Site 1784)

Chongqing, Chongqing Municipality, China

Site Status

The First Affiliated hospital of Xiamen University-Urology ( Site 1776)

Xiamen, Fujian, China

Site Status

SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777)

Guangzhou, Guangdong, China

Site Status

Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)

Guangzhou, Guangdong, China

Site Status

ShenZhen People's Hospital ( Site 1778)

Shenzhen, Guangdong, China

Site Status

Harbin Medical University Cancer Hospital-urology ( Site 1772)

Harbin, Heilongjiang, China

Site Status

Henan Cancer Hospital-Urology ( Site 1770)

Zhengzhou, Henan, China

Site Status

Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)

Wuhan, Hubei, China

Site Status

Wuhan Union Hospital ( Site 1771)

Wuhan, Hubei, China

Site Status

Hunan Cancer Hospital ( Site 1763)

Changsha, Hunan, China

Site Status

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S

Nanjing, Jiangsu, China

Site Status

The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)

Suzhou, Jiangsu, China

Site Status

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)

Xi'an, Shaanxi, China

Site Status

West China Hospital Sichuan University ( Site 1767)

Chengdu, Sichuan, China

Site Status

The Second Hospital of Tianjin Medical University ( Site 1769)

Tianjin, Tianjin Municipality, China

Site Status

Zhejiang Provincial People's Hospital-Urology ( Site 1762)

Hangzhou, Zhejiang, China

Site Status

The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)

Wenzhou, Zhejiang, China

Site Status

Instituto de Cancerología-Oncology ( Site 1609)

Medellín, Antioquia, Colombia

Site Status

Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad

Rionegro, Antioquia, Colombia

Site Status

Administradora Country S.A. - Clinica del Country ( Site 1607)

Bogotá, Bogota D.C., Colombia

Site Status

Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)

Bogotá, Bogota D.C., Colombia

Site Status

Oncomedica S.A.-Oncomedica S.A ( Site 1604)

Montería, Departamento de Córdoba, Colombia

Site Status

Oncologos del Occidente ( Site 1608)

Pereira, Risaralda Department, Colombia

Site Status

Hemato Oncologos SA-Oncology ( Site 1601)

Cali, Valle del Cauca Department, Colombia

Site Status

Clínica Imbanaco S.A.S ( Site 1611)

Cali, Valle del Cauca Department, Colombia

Site Status

CIMCA ( Site 1550)

San José, Provincia de San José, Costa Rica

Site Status

Policlinico San Bosco ( Site 0600)

San José, , Costa Rica

Site Status

Tampere University Hospital [Tampere Finland] ( Site 0201)

Tampere, Pirkanmaa, Finland

Site Status

Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)

Dijon, Bourgogne-Franche-Comté, France

Site Status

Hôpital Foch-Urology department ( Site 1351)

Suresnes, Hauts-de-Seine, France

Site Status

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)

Rennes, Ille-et-Vilaine, France

Site Status

Hopital Claude Huriez - CHU de Lille ( Site 1360)

Lille, Nord, France

Site Status

HENRI MONDOR HOSPITAL ( Site 1357)

Créteil, Seine-et-Marne, France

Site Status

Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)

Munich, Bavaria, Germany

Site Status

Klinikum Weiden ( Site 0259)

Weiden in Der Oberpfalz, Bavaria, Germany

Site Status

Universitaetsklinikum Wuerzburg ( Site 0265)

Würzburg, Bavaria, Germany

Site Status

Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)

Trier, Rhineland-Palatinate, Germany

Site Status

Universitaetsklinikum Jena ( Site 0252)

Jena, Thuringia, Germany

Site Status

Olympion General Clinic ( Site 0306)

Pátrai, Achaia, Greece

Site Status

General University Hospital of Patras ( Site 0302)

Pátrai, Achaia, Greece

Site Status

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)

Chaïdári, Attica, Greece

Site Status

Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)

Thessaloniki, Central Macedonia, Greece

Site Status

University Hospital of Larissa ( Site 0301)

Larissa, Thessaly, Greece

Site Status

INTEGRA Cancer Institute ( Site 1451)

Guatemala City, , Guatemala

Site Status

Onco Go, S.A ( Site 1454)

Guatemala City, , Guatemala

Site Status

Grupo Medico Angeles ( Site 1453)

Guatemala City, , Guatemala

Site Status

Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)

Pécs, Baranya, Hungary

Site Status

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)

Szeged, Csongrád megye, Hungary

Site Status

Semmelweis University-Urológiai Klinika ( Site 1301)

Budapest, , Hungary

Site Status

Debreceni Egyetem Klinikai Kozpont ( Site 1302)

Debrecen, , Hungary

Site Status

Ospedale Clinicizzato Santissima Annunziata ( Site 0361)

Chieti, Abruzzo, Italy

Site Status

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)

Milan, Milano, Italy

Site Status

Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)

Turin, Piedmont, Italy

Site Status

Osp Generale Reg di Bolzano ( Site 0355)

Bolzano, Trentino-Alto Adige, Italy

Site Status

Azienda Ospedaliero Universitaria Careggi ( Site 0360)

Florence, Tuscany, Italy

Site Status

Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)

Arezzo, , Italy

Site Status

Istituto Tumori Giovanni Paolo II ( Site 0357)

Bari, , Italy

Site Status

Ospedale San Martino ( Site 0351)

Genova, , Italy

Site Status

IRCCS Ospedale San Raffaele ( Site 0362)

Milan, , Italy

Site Status

Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)

Palermo, , Italy

Site Status

Policlinico Universitario A. Gemelli ( Site 0358)

Roma, , Italy

Site Status

A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)

Verona, , Italy

Site Status

Hirosaki University Hospital ( Site 0407)

Hirosaki, Aomori, Japan

Site Status

Ehime University Hospital ( Site 0414)

Tōon, Ehime, Japan

Site Status

University of Tsukuba Hospital ( Site 0412)

Tsukuba, Ibaraki, Japan

Site Status

St. Marianna University Hospital ( Site 0415)

Kawasaki, Kanagawa, Japan

Site Status

Kitasato University Hospital ( Site 0403)

Sagamihara, Kanagawa, Japan

Site Status

Yokosuka Kyosai Hospital ( Site 0406)

Yokosuka, Kanagawa, Japan

Site Status

Nara Medical University Hospital ( Site 0411)

Kashihara, Nara, Japan

Site Status

Hamamatsu University Hospital ( Site 0416)

Hamamatsu, Shizuoka, Japan

Site Status

Chiba Cancer Center ( Site 0401)

Chiba, , Japan

Site Status

Harasanshin Hospital ( Site 0410)

Fukuoka, , Japan

Site Status

Osaka International Cancer Institute ( Site 0413)

Osaka, , Japan

Site Status

Osaka Metropolitan University Hospital ( Site 0404)

Osaka, , Japan

Site Status

Institute of Science Tokyo Hospital ( Site 0409)

Tokyo, , Japan

Site Status

Keio University Hospital ( Site 0405)

Tokyo, , Japan

Site Status

University Malaya Medical Centre ( Site 1180)

Kuala Lumpur, , Malaysia

Site Status

Maastricht University Medical Centre ( Site 0453)

Maastricht, Limburg, Netherlands

Site Status

Erasmus MC ( Site 0451)

Rotterdam, South Holland, Netherlands

Site Status

Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)

Utrecht, , Netherlands

Site Status

Akershus University Hospital ( Site 0553)

Lorenskog, Akershus, Norway

Site Status

Stavanger universitetssykehus ( Site 0555)

Stavanger, Rogaland, Norway

Site Status

Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)

La Victoria, Lima region, Peru

Site Status

Oncosalud ( Site 0603)

Lima, Muni Metro de Lima, Peru

Site Status

Hospital Militar Central [Lima, Peru] ( Site 0604)

Lima, , Peru

Site Status

Clinical Research Center Sp. z o.o. ( Site 0674)

Poznan, Greater Poland Voivodeship, Poland

Site Status

MICS Centrum Medyczne Torun ( Site 0679)

Torun, Kuyavian-Pomeranian Voivodeship, Poland

Site Status

Pratia MCM Krakow ( Site 0668)

Krakow, Lesser Poland Voivodeship, Poland

Site Status

Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)

Tarnów, Lesser Poland Voivodeship, Poland

Site Status

Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)

Siedlce, Masovian Voivodeship, Poland

Site Status

Luxmed Onkologia sp. z o. o. ( Site 0653)

Warsaw, Masovian Voivodeship, Poland

Site Status

Medical Concierge Centrum Medyczne ( Site 0676)

Warsaw, Masovian Voivodeship, Poland

Site Status

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)

Przemyśl, Podkarpackie Voivodeship, Poland

Site Status

Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)

Kościerzyna, Pomeranian Voivodeship, Poland

Site Status

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)

Słupsk, Pomeranian Voivodeship, Poland

Site Status

LIFTMED ( Site 0652)

Rybnik, Silesian Voivodeship, Poland

Site Status

Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 0702)

Lisbon, Lisbon District, Portugal

Site Status

Unidade Local de Saude de Braga - Hospital de Braga ( Site 0705)

Braga, , Portugal

Site Status

Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)

Coimbra, , Portugal

Site Status

Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)

Lisbon, , Portugal

Site Status

Hospital CUF Descobertas ( Site 0706)

Lisbon, , Portugal

Site Status

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)

Porto, , Portugal

Site Status

Advance Urology and Laparoscopic Center ( Site 0757)

Ponce, , Puerto Rico

Site Status

Ad-Vance Medical Research ( Site 0756)

Ponce, , Puerto Rico

Site Status

Asan Medical Center ( Site 0804)

Songpagu, Seoul, South Korea

Site Status

Korea University Anam Hospital ( Site 0801)

Seoul, , South Korea

Site Status

Seoul National University Hospital ( Site 0802)

Seoul, , South Korea

Site Status

Samsung Medical Center ( Site 0803)

Seoul, , South Korea

Site Status

Hospital Universitario Lucus Augusti ( Site 0852)

Lugo, La Coruna, Spain

Site Status

Hospital Universitario Quiron Madrid ( Site 0862)

Pozuelo de Alarcón, Madrid, Comunidad de, Spain

Site Status

Clinica Universitaria de Navarra ( Site 0863)

Pamplona, Navarre, Spain

Site Status

Fundacio Puigvert ( Site 0864)

Barcelona, , Spain

Site Status

Hospital Universitario Gregorio Maranon ( Site 0854)

Madrid, , Spain

Site Status

Clinica Universitaria Navarra - Madrid ( Site 0860)

Madrid, , Spain

Site Status

MD Anderson Cancer Center Madrid ( Site 0859)

Madrid, , Spain

Site Status

Hospital Universitario Ramon y Cajal ( Site 0857)

Madrid, , Spain

Site Status

Hospital Universitario La Paz ( Site 0866)

Madrid, , Spain

Site Status

Hospital La Fe de Valencia ( Site 0855)

Valencia, , Spain

Site Status

Universitaetsspital Basel ( Site 1201)

Basel, Canton of Basel-City, Switzerland

Site Status

Hopitaux Universitaires de Geneve HUG ( Site 1204)

Geneva, , Switzerland

Site Status

Universitaetsspital Zurich ( Site 1203)

Zurich, , Switzerland

Site Status

Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)

Ankara, , Turkey (Türkiye)

Site Status

Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)

Eskişehir, , Turkey (Türkiye)

Site Status

Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)

Istanbul, , Turkey (Türkiye)

Site Status

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)

Istanbul, , Turkey (Türkiye)

Site Status

Dokuz Eylul Universitesi ( Site 0959)

Izmir, , Turkey (Türkiye)

Site Status

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)

Konya, , Turkey (Türkiye)

Site Status

Raigmore Hospital ( Site 1006)

Inverness, Highland, United Kingdom

Site Status

St Bartholomew s Hospital ( Site 1008)

London, London, City of, United Kingdom

Site Status

St Georges University Hospitals NHS Foundation Trust. ( Site 1005)

London, London, City of, United Kingdom

Site Status

Countries

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Taiwan United States Australia Austria Belgium Brazil Canada China Colombia Costa Rica Finland France Germany Greece Guatemala Hungary Italy Japan Malaysia Netherlands Norway Peru Poland Portugal Puerto Rico South Korea Spain Switzerland Turkey (Türkiye) United Kingdom

References

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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.

Reference Type DERIVED
PMID: 32162533 (View on PubMed)

Related Links

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Other Identifiers

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MK-3475-676

Identifier Type: OTHER

Identifier Source: secondary_id

194713

Identifier Type: OTHER

Identifier Source: secondary_id

jRCT2031200390

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-501817-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1282-1555

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-001967-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

3475-676

Identifier Type: -

Identifier Source: org_study_id