Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)
7 other identifiers
interventional
1,397
28 countries
197
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2018
Longer than P75 for phase_3
197 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
October 18, 2018
CompletedStudy Start
First participant enrolled
December 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 20, 2034
May 1, 2026
April 1, 2026
7.6 years
October 15, 2018
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
CRR is defined as the percentage of participants with carcinoma in situ (CIS) achieving a complete response (CR).
Up to ~3.5 years
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.
Up to ~5 years
Secondary Outcomes (18)
EFS (Cohort A)
Up to ~5 years
Recurrence-Free Survival (RFS) (Cohorts A and B)
Up to ~5 years
Overall Survival (OS) (Cohorts A and B)
Up to ~5 years
Disease Specific Survival (DSS) (Cohorts A and B)
Up to ~5 years
Time to Cystectomy (Cohorts A and B)
Up to ~5 years
- +13 more secondary outcomes
Study Arms (5)
BCG plus Pembrolizumab: Post-induction Cohort A (Arm A-1)
EXPERIMENTALParticipants receive BCG (Induction and Maintenance) in combination with 200 mg pembrolizumab administered intravenously (IV) every 3 weeks (Q3W) for 35 doses (\~2 years).
BCG Monotherapy: Post-induction Cohort A (Arm A-2)
EXPERIMENTALParticipants receive BCG monotherapy (Induction and Maintenance).
BCG plus Pembrolizumab: BCG Naïve Cohort B-Reduced Maintenance (Arm B-1)
EXPERIMENTALParticipants receive BCG (Induction and reduced Maintenance) in combination with 400 mg pembrolizumab administered IV every 6 weeks (Q6W) for 9 doses (\~1 year).
BCG plus Pembrolizumab: BCG Naïve Cohort B-Full Maintenance (Arm B-2)
EXPERIMENTALParticipants receive BCG (Induction and full Maintenance) in combination with 400 mg pembrolizumab administered IV Q6W for 9 doses (\~1 year).
BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)
EXPERIMENTALParticipants receive BCG monotherapy (Induction and Maintenance).
Interventions
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 (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (209)
Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)
Anchorage, Alaska, 99503, United States
Mayo Clinic in Arizona - Phoenix ( Site 1094)
Phoenix, Arizona, 85054, United States
Del Sol Research Management, LLC ( Site 1096)
Tucson, Arizona, 85715, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 1052)
Los Angeles, California, 90095, United States
University of California Irvine Medical Center ( Site 1061)
Orange, California, 92868, United States
Genesis Research LLC ( Site 1065)
Torrance, California, 90505, United States
Colorado Clinical Research ( Site 1100)
Lakewood, Colorado, 80228, United States
Urological Research Network ( Site 1106)
Hialeah, Florida, 33016, United States
Mayo Clinic in Florida-Urology ( Site 1097)
Jacksonville, Florida, 32224, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)
Miami, Florida, 33136, United States
Woodlands Medical Specialists, PA ( Site 8002)
Pensacola, Florida, 32503, United States
Emory School of Medicine ( Site 1076)
Atlanta, Georgia, 30322, United States
Advanced Urology ( Site 1092)
Roswell, Georgia, 30076, United States
Northwestern Memorial Hospital ( Site 1101)
Chicago, Illinois, 60611, United States
Wichita Urology Group ( Site 1086)
Wichita, Kansas, 67226, United States
Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)
Shreveport, Louisiana, 71106, United States
Henry Ford Hospital ( Site 1062)
Detroit, Michigan, 48202, United States
Michigan Institute of Urology ( Site 1077)
Troy, Michigan, 48084, United States
Coastal Urology Associates ( Site 1055)
Brick, New Jersey, 08724, United States
Morristown Medical Center ( Site 1090)
Morristown, New Jersey, 07960, United States
Rutgers Cancer Institute of New Jersey ( Site 1059)
New Brunswick, New Jersey, 08901, United States
St. Peter's Hospital Cancer Care Center ( Site 1087)
Albany, New York, 12208, United States
R.J. Zuckerberg Cancer Center ( Site 1080)
Lake Success, New York, 11042, United States
Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)
New York, New York, 10010, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)
New York, New York, 10016, United States
Associated Medical Professionals of NY ( Site 1078)
Syracuse, New York, 13210, United States
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)
Cincinnati, Ohio, 45212, United States
University Hospitals Cleveland Medical Center ( Site 1066)
Cleveland, Ohio, 44106, United States
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 1067)
Columbus, Ohio, 43210, United States
OHSU Knight Cancer Institute ( Site 1075)
Portland, Oregon, 97210, United States
Oregon Urology Institute ( Site 1098)
Springfield, Oregon, 97477, United States
MidLantic Urology ( Site 1071)
Bala-Cynwyd, Pennsylvania, 19004, United States
Lancaster Urology ( Site 1079)
Lancaster, Pennsylvania, 17604, United States
University of Pennsylvania ( Site 1088)
Philadelphia, Pennsylvania, 19104, United States
Carolina Urologic Research Center ( Site 1085)
Myrtle Beach, South Carolina, 29572, United States
Urology Associates [Nashville, TN] ( Site 1072)
Nashville, Tennessee, 37209, United States
Urology Clinics of North Texas, PLLC ( Site 1064)
Dallas, Texas, 75231, United States
University Of Texas Southwestern Medical Center ( Site 1053)
Dallas, Texas, 75390, United States
Texas Oncology-Fort Worth Cancer Center ( Site 8003)
Fort Worth, Texas, 76104, United States
Houston Metro Urology ( Site 1111)
Houston, Texas, 77027, United States
Texas Oncology-Plano West ( Site 8001)
Plano, Texas, 75093, United States
Urology San Antonio Research ( Site 1108)
San Antonio, Texas, 78229, United States
University of Vermont Medical Center ( Site 1057)
Burlington, Vermont, 05401, United States
Urology of Virginia ( Site 1070)
Virginia Beach, Virginia, 23462, United States
GenesisCare North Shore ( Site 0010)
St Leonards, New South Wales, 2065, Australia
Northern Cancer Institute. ( Site 0003)
St Leonards, New South Wales, 2065, Australia
Sydney Adventist Hospital ( Site 0001)
Wahroonga, New South Wales, 2076, Australia
Epworth Hospital ( Site 0009)
Richmond, Victoria, 3121, Australia
Medizinische Universität Wien ( Site 0054)
Vienna, State of Vienna, 1090, Austria
Univ. Klinik f. Urologie Innsbruck ( Site 0051)
Innsbruck, Tyrol, 6020, Austria
Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)
Linz, Upper Austria, 4020, Austria
Universitaetsklinik Salzburg ( Site 0053)
Salzburg, 5020, Austria
UZA University Hospital Antwerp ( Site 0105)
Edegem, Antwerpen, 2650, Belgium
CHU UCL Namur Site de Godinne ( Site 0103)
Yvoir, Namur, 5530, Belgium
AZORG Campus Aalst-Moorselbaan ( Site 0106)
Aalst, Oost-Vlaanderen, 9300, Belgium
AZ Maria Middelares Gent ( Site 0102)
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Gent ( Site 0101)
Ghent, Oost-Vlaanderen, 9000, Belgium
Hospital São Carlos-Oncocentro Ce ( Site 1558)
Fortaleza, Ceará, 60135-237, Brazil
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)
Curitiba, Paraná, 81520-060, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)
Barretos, São Paulo, 14784-400, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)
São Paulo, 01246-000, Brazil
BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)
São Paulo, 01321-001, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)
São Paulo, 04014-002, Brazil
Exdeo Clinical Research Inc. ( Site 0165)
Abbotsford British Columbia, British Columbia, V2T 1X8, Canada
Silverado Resarch Inc. ( Site 0155)
Victoria, British Columbia, V8T 2C1, Canada
Horizon Health Network ( Site 0160)
Moncton, New Brunswick, E1C 6Z8, Canada
Princess Margaret Cancer Centre ( Site 0153)
Toronto, Ontario, M5G 2M9, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)
Chicoutimi, Quebec, G7H 5H6, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)
Montreal, Quebec, H1T 2M4, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0151)
Québec, Quebec, G1J 1Z4, Canada
CHUS - Hopital Fleurimont ( Site 0152)
Sherbrooke, Quebec, J1H 5N4, Canada
Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)
Beijing, Beijing Municipality, 100021, China
Peking University First Hospital ( Site 1759)
Beijing, Beijing Municipality, 100034, China
Beijing Cancer hospital-Urinary Surgery ( Site 1755)
Beijing, Beijing Municipality, 100142, China
Chongqing University Cancer Hospital ( Site 1784)
Chongqing, Chongqing Municipality, 400030, China
The First Affiliated hospital of Xiamen University-Urology ( Site 1776)
Xiamen, Fujian, 361003, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)
Guangzhou, Guangdong, 510060, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 1777)
Guangzhou, Guangdong, 510120, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)
Guangzhou, Guangdong, 510289, China
ShenZhen People's Hospital ( Site 1778)
Shenzhen, Guangdong, 518020, China
Harbin Medical University Cancer Hospital ( Site 1772)
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital-Urology ( Site 1770)
Zhengzhou, Henan, 450008, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)
Wuhan, Hubei, 430000, China
Wuhan Union Hospital ( Site 1771)
Wuhan, Hubei, 430022, China
Hunan Cancer Hospital ( Site 1763)
Changsha, Hunan, 410013, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 1758)
Nanjing, Jiangsu, 210008, China
The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)
Xi'an, Shaanxi, 710061, China
West China Hospital Sichuan University ( Site 1767)
Chengdu, Sichuan, 610041, China
The Second Hospital of Tianjin Medical University ( Site 1769)
Tianjin, Tianjin Municipality, 300211, China
Zhejiang Provincial People's Hospital-Urology ( Site 1762)
Hangzhou, Zhejiang, 310014, China
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)
Wenzhou, Zhejiang, 325000, China
Instituto de Cancerología-Oncology ( Site 1609)
Medellín, Antioquia, 050024, Colombia
Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad ( Site 1606)
Rionegro, Antioquia, 054047, Colombia
Administradora Country S.A. - Clinica del Country ( Site 1607)
Bogotá, Bogota D.C., 110221, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)
Bogotá, Bogota D.C., 111321, Colombia
IMAT S.A.S ( Site 1604)
Montería, Departamento de Córdoba, 230002, Colombia
Oncologos del Occidente ( Site 1608)
Pereira, Risaralda Department, 661001, Colombia
Hemato Oncologos SA-Oncology ( Site 1601)
Cali, Valle del Cauca Department, 76001, Colombia
Clínica Imbanaco S.A.S ( Site 1611)
Cali, Valle del Cauca Department, 760042, Colombia
CIMCA ( Site 1550)
San José, Provincia de San José, 10103, Costa Rica
Policlinico San Bosco ( Site 0600)
San José, 10103, Costa Rica
Tampere University Hospital [Tampere Finland] ( Site 0201)
Tampere, Pirkanmaa, 33520, Finland
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)
Dijon, Bourgogne-Franche-Comté, 21000, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)
Rennes, Brittany Region, 35000, France
Hôpital Foch-Urology department ( Site 1351)
Suresnes, Hauts-de-Seine, 92150, France
Hopital Claude Huriez - CHU de Lille ( Site 1360)
Lille, Nord, 59037, France
HENRI MONDOR HOSPITAL ( Site 1357)
Créteil, Seine-et-Marne, 94000, France
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)
Munich, Bavaria, 81675, Germany
Klinikum Weiden ( Site 0259)
Weiden in Der Oberpfalz, Bavaria, 92637, Germany
Universitaetsklinikum Wuerzburg ( Site 0265)
Würzburg, Bavaria, 97080, Germany
Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)
Trier, Rhineland-Palatinate, 54292, Germany
Universitaetsklinikum Jena ( Site 0252)
Jena, Thuringia, 07747, Germany
Olympion General Clinic ( Site 0306)
Pátrai, Achaia, 264 43, Greece
General University Hospital of Patras ( Site 0302)
Pátrai, Achaia, 265 04, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)
Chaïdári, Attica, 124 62, Greece
Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)
Thessaloniki, Central Macedonia, 54007, Greece
University Hospital of Larissa ( Site 0301)
Larissa, Thessaly, 411 10, Greece
INTEGRA Cancer Institute ( Site 1451)
Guatemala City, 01010, Guatemala
Onco Go, S.A ( Site 1454)
Guatemala City, 01010, Guatemala
Grupo Medico Angeles ( Site 1453)
Guatemala City, 01015, Guatemala
Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)
Pécs, Baranya, 7621, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)
Szeged, Csongrád megye, 6725, Hungary
Semmelweis University-Urológiai Klinika ( Site 1301)
Budapest, 1082, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1302)
Debrecen, 4032, Hungary
Ospedale Clinicizzato Santissima Annunziata ( Site 0361)
Chieti, Abruzzo, 66100, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)
Milan, Milano, 20133, Italy
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)
Turin, Piedmont, 10128, Italy
Osp Generale Reg di Bolzano ( Site 0355)
Bolzano, Trentino-Alto Adige, 39100, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 0360)
Florence, Tuscany, 50134, Italy
Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)
Arezzo, 52100, Italy
Istituto Tumori Giovanni Paolo II ( Site 0357)
Bari, 70124, Italy
Ospedale San Martino ( Site 0351)
Genova, 16132, Italy
IRCCS Ospedale San Raffaele ( Site 0362)
Milan, 20132, Italy
Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)
Palermo, 90123, Italy
Policlinico Universitario A. Gemelli ( Site 0358)
Roma, 00168, Italy
A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)
Verona, 37126, Italy
Hirosaki University Hospital ( Site 0407)
Hirosaki, Aomori, 036-8563, Japan
Ehime University Hospital ( Site 0414)
Tōon, Ehime, 791-0295, Japan
University of Tsukuba Hospital ( Site 0412)
Tsukuba, Ibaraki, 305-8576, Japan
St. Marianna University Hospital ( Site 0415)
Kawasaki, Kanagawa, 216-8511, Japan
Kitasato University Hospital ( Site 0403)
Sagamihara, Kanagawa, 252-0375, Japan
Yokosuka Kyosai Hospital ( Site 0406)
Yokosuka, Kanagawa, 238-8558, Japan
Nara Medical University Hospital ( Site 0411)
Kashihara, Nara, 634-8522, Japan
Hamamatsu University Hospital ( Site 0416)
Hamamatsu, Shizuoka, 431-3192, Japan
Chiba Cancer Center ( Site 0401)
Chiba, 260-8717, Japan
Harasanshin Hospital ( Site 0410)
Fukuoka, 812-0033, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 0413)
Osaka, 541-8567, Japan
Osaka Metropolitan University Hospital ( Site 0404)
Osaka, 545-8586, Japan
Institute of Science Tokyo Hospital ( Site 0409)
Tokyo, 113-8519, Japan
Keio University Hospital ( Site 0405)
Tokyo, 160-8582, Japan
University Malaya Medical Centre ( Site 1180)
Kuala Lumpur, 59100, Malaysia
Maastricht University Medical Centre ( Site 0453)
Maastricht, Limburg, 6229 HX, Netherlands
Erasmus MC ( Site 0451)
Rotterdam, South Holland, 3015 GD, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)
Utrecht, 3584 CX, Netherlands
Akershus University Hospital ( Site 0553)
Lorenskog, Akershus, 1478, Norway
Stavanger universitetssykehus ( Site 0555)
Stavanger, Rogaland, 4011, Norway
Oncosalud ( Site 0603)
Lima, Lima Province, 15036, Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)
La Victoria, Lima region, 15033, Peru
Hospital Militar Central [Lima, Peru] ( Site 0604)
Lima, 15076, Peru
Clinical Research Center Sp. z o.o. ( Site 0674)
Poznan, Greater Poland Voivodeship, 61-731, Poland
MICS Centrum Medyczne Torun ( Site 0679)
Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland
Pratia MCM Krakow ( Site 0668)
Krakow, Lesser Poland Voivodeship, 30-510, Poland
Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)
Wroclaw, Lower Silesian Voivodeship, 50-556, Poland
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
Siedlce, Masovian Voivodeship, 08-110, Poland
Luxmed Onkologia sp. z o. o. ( Site 0653)
Warsaw, Masovian Voivodeship, 01-748, Poland
Medical Concierge Centrum Medyczne ( Site 0676)
Warsaw, Masovian Voivodeship, 02-798, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)
Przemyśl, Podkarpackie Voivodeship, 37-700, Poland
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)
Kościerzyna, Pomeranian Voivodeship, 83-400, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)
Słupsk, Pomeranian Voivodeship, 76-200, Poland
LIFTMED ( Site 0652)
Rybnik, Silesian Voivodeship, 44-200, Poland
Unidade Local de Saude de Braga - Hospital de Braga ( Site 0705)
Braga, 4710-243, Portugal
Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)
Coimbra, 3000-075, Portugal
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)
Lisbon, 1099-023, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 0702)
Lisbon, 1649-035, Portugal
Hospital CUF Descobertas ( Site 0706)
Lisbon, 1998-018, Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)
Porto, 4200-072, Portugal
Advance Urology and Laparoscopic Center ( Site 0757)
Ponce, 00716, Puerto Rico
Ad-Vance Medical Research ( Site 0756)
Ponce, 00717, Puerto Rico
Asan Medical Center ( Site 0804)
Songpagu, Seoul, 05505, South Korea
Korea University Anam Hospital ( Site 0801)
Seoul, 02841, South Korea
Seoul National University Hospital ( Site 0802)
Seoul, 03080, South Korea
Samsung Medical Center ( Site 0803)
Seoul, 06351, South Korea
Hospital Universitario Lucus Augusti ( Site 0852)
Lugo, La Coruna, 27003, Spain
Hospital Universitario Quiron Madrid ( Site 0862)
Pozuelo de Alarcón, Madrid, Comunidad de, 28223, Spain
Clinica Universitaria de Navarra ( Site 0863)
Pamplona, Navarre, 31008, Spain
Fundacio Puigvert ( Site 0864)
Barcelona, 08025, Spain
Hospital Universitario Gregorio Maranon ( Site 0854)
Madrid, 28009, Spain
Clinica Universitaria Navarra - Madrid ( Site 0860)
Madrid, 28027, Spain
MD Anderson Cancer Center Madrid ( Site 0859)
Madrid, 28033, Spain
Hospital Universitario Ramon y Cajal ( Site 0857)
Madrid, 28034, Spain
Hospital Universitario La Paz ( Site 0866)
Madrid, 28046, Spain
Hospital La Fe de Valencia ( Site 0855)
Valencia, 46026, Spain
Universitaetsspital Basel ( Site 1201)
Basel, Canton of Basel-City, 4031, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 1204)
Geneva, 1205, Switzerland
Universitaetsspital Zurich ( Site 1203)
Zurich, 8091, Switzerland
China Medical University Hospital-Department of Urology ( Site 1654)
Taichung, 40447, Taiwan
Taichung Veterans General Hospital ( Site 1653)
Taichung, 407, Taiwan
Taipei Veterans General Hospital ( Site 1652)
Taipei, 112, Taiwan
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)
Ankara, 06590, Turkey (Türkiye)
Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)
Eskişehir, 26480, Turkey (Türkiye)
Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)
Istanbul, 34385, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)
Istanbul, 34722, Turkey (Türkiye)
Dokuz Eylul Universitesi ( Site 0959)
Izmir, 35340, Turkey (Türkiye)
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)
Konya, 42000, Turkey (Türkiye)
Raigmore Hospital ( Site 1006)
Inverness, Highland, IV2 3UJ, United Kingdom
St Bartholomew s Hospital ( Site 1008)
London, London, City of, EC1A 7BE, United Kingdom
St Georges University Hospitals NHS Foundation Trust. ( Site 1005)
London, London, City of, SW17 0QT, United Kingdom
Related Publications (1)
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.
PMID: 32162533DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 15, 2018
First Posted
October 18, 2018
Study Start
December 24, 2018
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
November 20, 2034
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf