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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,397

Participants

Timeline

Start Date

December 24, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

November 20, 2034

Conditions
High-risk Non-muscle Invasive Bladder Cancer
Interventions
BIOLOGICAL

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

BIOLOGICAL

BCG

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

Trial Locations (206)

1082

Semmelweis University-Urológiai Klinika ( Site 1301), Budapest

1090

Medizinische Universität Wien ( Site 0054), Vienna

1205

Hopitaux Universitaires de Geneve HUG ( Site 1204), Geneva

1478

Akershus University Hospital ( Site 0553), Lorenskog

2065

GenesisCare North Shore ( Site 0010), St Leonards

Northern Cancer Institute. ( Site 0003), St Leonards

2076

Sydney Adventist Hospital ( Site 0001), Wahroonga

2650

UZA University Hospital Antwerp ( Site 0105), Edegem

3121

Epworth Hospital ( Site 0009), Richmond

4011

Stavanger universitetssykehus ( Site 0555), Stavanger

4020

Ordensklinikum Linz GmbH Elisabethinen ( Site 0052), Linz

4031

Universitaetsspital Basel ( Site 1201), Basel

4032

Debreceni Egyetem Klinikai Kozpont ( Site 1302), Debrecen

5020

Universitaetsklinik Salzburg ( Site 0053), Salzburg

5530

CHU UCL Namur Site de Godinne ( Site 0103), Yvoir

6020

Univ. Klinik f. Urologie Innsbruck ( Site 0051), Innsbruck

6725

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

7621

Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304), Pécs

8091

Universitaetsspital Zurich ( Site 1203), Zurich

9000

AZ Maria Middelares Gent ( Site 0102), Ghent

UZ Gent ( Site 0101), Ghent

9300

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

10010

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

10016

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

10103

CIMCA ( Site 1550), San José

Policlinico San Bosco ( Site 0600), San José

10128

Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366), Turin

11042

R.J. Zuckerberg Cancer Center ( Site 1080), Lake Success

12208

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

13210

Associated Medical Professionals of NY ( Site 1078), Syracuse

15033

Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601), La Victoria

15036

Oncosalud ( Site 0603), Lima

15076

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

16132

Ospedale San Martino ( Site 0351), Genova

17604

Lancaster Urology ( Site 1079), Lancaster

19004

MidLantic Urology ( Site 1071), Bala-Cynwyd

19104

University of Pennsylvania ( Site 1088), Philadelphia

20132

IRCCS Ospedale San Raffaele ( Site 0362), Milan

20133

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

21000

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

23462

Urology of Virginia ( Site 1070), Virginia Beach

26480

Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953), Eskişehir

27003

Hospital Universitario Lucus Augusti ( Site 0852), Lugo

28007

Hospital Universitario Gregorio Maranon ( Site 0854), Madrid

28027

Clinica Universitaria Navarra - Madrid ( Site 0860), Madrid

28033

MD Anderson Cancer Center Madrid ( Site 0859), Madrid

28034

Hospital Universitario Ramon y Cajal ( Site 0857), Madrid

28046

Hospital Universitario La Paz ( Site 0866), Madrid

28223

Hospital Universitario Quiron Madrid ( Site 0862), Pozuelo de Alarcón

29572

Carolina Urologic Research Center ( Site 1085), Myrtle Beach

30076

Advanced Urology ( Site 1092), Roswell

30322

Emory School of Medicine ( Site 1076), Atlanta

31008

Clinica Universitaria de Navarra ( Site 0863), Pamplona

32224

Mayo Clinic in Florida-Urology ( Site 1097), Jacksonville

32503

Woodlands Medical Specialists, PA ( Site 8002), Pensacola

33016

Urological Research Network ( Site 1106), Hialeah

33136

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

33520

Tampere University Hospital [Tampere Finland] ( Site 0201), Tampere

34385

Memorial Sisli Hastanesi-Medical Oncology ( Site 0965), Istanbul

34722

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

35000

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

35340

Dokuz Eylul Universitesi ( Site 0959), Izmir

37126

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

37209

Urology Associates [Nashville, TN] ( Site 1072), Nashville

39100

Osp Generale Reg di Bolzano ( Site 0355), Bolzano

42000

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961), Konya

43210

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

44106

University Hospitals Cleveland Medical Center ( Site 1066), Cleveland

45212

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

46026

Hospital La Fe de Valencia ( Site 0855), Valencia

48084

Michigan Institute of Urology ( Site 1077), Troy

48202

Henry Ford Health System ( Site 1062), Detroit

50134

Azienda Ospedaliero Universitaria Careggi ( Site 0360), Florence

52100

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

54007

Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303), Thessaloniki

54292

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

59037

Hopital Claude Huriez - CHU de Lille ( Site 1360), Lille

59100

University Malaya Medical Centre ( Site 1180), Kuala Lumpur

60611

Northwestern Memorial Hospital ( Site 1101), Chicago

66100

Ospedale Clinicizzato Santissima Annunziata ( Site 0361), Chieti

67226

Wichita Urology Group ( Site 1086), Wichita

70124

Istituto Tumori Giovanni Paolo II ( Site 0357), Bari

71106

Ochsner LSU Health Shreveport - Regional Urology ( Site 1099), Shreveport

75093

Texas Oncology-Plano West ( Site 8001), Plano

75231

Urology Clinics of North Texas, PLLC ( Site 1064), Dallas

75390

University Of Texas Southwestern Medical Center ( Site 1053), Dallas

76001

Hemato Oncologos SA-Oncology ( Site 1601), Santiago de Cali

76104

Texas Oncology-Fort Worth Cancer Center ( Site 8003), Fort Worth

77027

Houston Metro Urology ( Site 1111), Houston

78229

Urology San Antonio Research ( Site 1108), San Antonio

80228

Colorado Clinical Research ( Site 1100), Lakewood

81675

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

85054

Mayo Clinic in Arizona - Phoenix ( Site 1094), Phoenix

85704

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

90095

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

90123

Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352), Palermo

90505

Genesis Research LLC ( Site 1065), Torrance

92150

Hôpital Foch-Urology department ( Site 1351), Suresnes

92637

Klinikum Weiden ( Site 0259), Weiden in Der Oberpfalz

92868

University of California Irvine Medical Center ( Site 1061), Orange

94000

HENRI MONDOR HOSPITAL ( Site 1357), Créteil

97080

Universitaetsklinikum Wuerzburg ( Site 0265), Würzburg

97210

OHSU Knight Cancer Institute ( Site 1075), Portland

97477

Oregon Urology Institute ( Site 1098), Springfield

99503

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

100021

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

100034

Peking University First Hospital ( Site 1759), Beijing

100142

Beijing Cancer hospital-Urinary Surgery ( Site 1755), Beijing

110221

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

111321

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

150081

Harbin Medical University Cancer Hospital-urology ( Site 1772), Harbin

210008

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

215004

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

230002

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

300211

The Second Hospital of Tianjin Medical University ( Site 1769), Tianjin

310014

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

325000

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

361003

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

400030

Chongqing University Cancer Hospital ( Site 1784), Chongqing

410013

Hunan Cancer Hospital ( Site 1763), Changsha

430000

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

430010

Wuhan Union Hospital ( Site 1771), Wuhan

450008

Henan Cancer Hospital-Urology ( Site 1770), Zhengzhou

510060

SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752), Guangzhou

510120

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

510289

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

518020

ShenZhen People's Hospital ( Site 1778), Shenzhen

610041

West China Hospital Sichuan University ( Site 1767), Chengdu

661001

Oncologos del Occidente ( Site 1608), Pereira

710061

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

760042

Clínica Imbanaco S.A.S ( Site 1611), Santiago de Cali

81520060

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

08724

Coastal Urology Associates ( Site 1055), Brick

07960

Morristown Medical Center ( Site 1090), Morristown

08903

Rutgers Cancer Institute of New Jersey ( Site 1059), New Brunswick

05401

University of Vermont Medical Center ( Site 1057), Burlington

60135-237

Hospital São Carlos-Oncocentro Ce ( Site 1558), Fortaleza

14784-400

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

01246-000

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

01321-001

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

04014-002

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

V2T 1X8

Exdeo Clinical Research Inc. ( Site 0165), Abbotsford

V8T 2C1

Silverado Resarch Inc. ( Site 0155), Victoria

E1C 6Z8

Horizon Health Network ( Site 0160), Moncton

M5G 2M9

Princess Margaret Cancer Centre ( Site 0153), Toronto

G7H 5H6

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

H1T 2M4

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

G1J 1Z4

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

J1H 5N4

CHUS - Hopital Fleurimont ( Site 0152), Sherbrooke

050024

Instituto de Cancerología-Oncology ( Site 1609), Medellín

054047

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

07747

Universitaetsklinikum Jena ( Site 0252), Jena

264 43

Olympion General Clinic ( Site 0306), Pátrai

265 04

General University Hospital of Patras ( Site 0302), Pátrai

124 62

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304), Chaïdári

411 10

University Hospital of Larissa ( Site 0301), Larissa

01010

INTEGRA Cancer Institute ( Site 1451), Guatemala City

Onco Go, S.A ( Site 1454), Guatemala City

01015

Grupo Medico Angeles ( Site 1453), Guatemala City

00168

Policlinico Universitario A. Gemelli ( Site 0358), Roma

036-8563

Hirosaki University Hospital ( Site 0407), Hirosaki

791-0295

Ehime University Hospital ( Site 0414), Tōon

305-8576

University of Tsukuba Hospital ( Site 0412), Tsukuba

216-8511

St. Marianna University Hospital ( Site 0415), Kawasaki

252-0375

Kitasato University Hospital ( Site 0403), Sagamihara

238-8558

Yokosuka Kyosai Hospital ( Site 0406), Yokosuka

634-8522

Nara Medical University Hospital ( Site 0411), Kashihara

431-3192

Hamamatsu University Hospital ( Site 0416), Hamamatsu

260-8717

Chiba Cancer Center ( Site 0401), Chiba

812-0033

Harasanshin Hospital ( Site 0410), Fukuoka

541-8567

Osaka International Cancer Institute ( Site 0413), Osaka

545-8586

Osaka Metropolitan University Hospital ( Site 0404), Osaka

113-8519

Institute of Science Tokyo Hospital ( Site 0409), Tokyo

160-8582

Keio University Hospital ( Site 0405), Tokyo

6229 HX

Maastricht University Medical Centre ( Site 0453), Maastricht

3015 GD

Erasmus MC ( Site 0451), Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455), Utrecht

61-731

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

87-100

MICS Centrum Medyczne Torun ( Site 0679), Torun

30-510

Pratia MCM Krakow ( Site 0668), Krakow

33-100

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

50-556

Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669), Wroclaw

08-110

Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654), Siedlce

01-748

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

02-798

Medical Concierge Centrum Medyczne ( Site 0676), Warsaw

37-700

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

83-400

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

76-200

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

44-200

LIFTMED ( Site 0652), Rybnik

1649-035

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

4710-243

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

3000-075

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

1099-023

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

1998-018

Hospital CUF Descobertas ( Site 0706), Lisbon

4200-072

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

00716

Advance Urology and Laparoscopic Center ( Site 0757), Ponce

00717

Ad-Vance Medical Research ( Site 0756), Ponce

05505

Asan Medical Center ( Site 0804), Songpagu

02841

Korea University Anam Hospital ( Site 0801), Seoul

03080

Seoul National University Hospital ( Site 0802), Seoul

06351

Samsung Medical Center ( Site 0803), Seoul

08025

Fundacio Puigvert ( Site 0864), Barcelona

06590

Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966), Ankara

IV2 3UJ

Raigmore Hospital ( Site 1006), Inverness

EC1A 7BE

St Bartholomew s Hospital ( Site 1008), London

SW17 0QT

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

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY