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)

March 20, 2024 updated by: Merck Sharp & Dohme LLC

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)

This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with BCG, compared to BCG monotherapy, in participants with HR NMIBC that is either persistent or recurrent following adequate BCG induction (Cohort A), or that is naïve to BCG treatment (Cohort B). The primary hypothesis for Cohort A is that the combination of pembrolizumab plus BCG has a superior complete response rate (CRR) as assessed by central pathology review compared to BCG in participants with carcinoma in situ (CIS). The primary hypothesis for Cohort B is that the combination of pembrolizumab plus BCG (either reduced maintenance or full maintenance) has a superior Event Free Survival (EFS) compared to BCG.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1405

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • GenesisCare North Shore ( Site 0010)
        • Contact:
          • Study Coordinator
          • Phone Number: 61294631172
      • St Leonards, New South Wales, Australia, 2065
        • Completed
        • Northern Cancer Institute. ( Site 0003)
      • Wahroonga, New South Wales, Australia, 2076
        • Completed
        • Sydney Adventist Hospital ( Site 0001)
    • Victoria
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Epworth Hospital ( Site 0009)
        • Contact:
          • Study Coordinator
          • Phone Number: 0390085443
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Universitaetsklinik Salzburg ( Site 0053)
        • Contact:
          • Study Coordinator
          • Phone Number: +435725527400
    • Oberosterreich
      • Linz, Oberosterreich, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH Elisabethinen ( Site 0052)
        • Contact:
          • Study Coordinator
          • Phone Number: +4373276777727
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Completed
        • Univ. Klinik f. Urologie Innsbruck ( Site 0051)
    • Wien
      • Vienna, Wien, Austria, 1090
        • Recruiting
        • Medizinische Universität Wien ( Site 0054)
        • Contact:
          • Study Coordinator
          • Phone Number: +4367761942300
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • UZA University Hospital Antwerp ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: +3238213718
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Recruiting
        • CHU UCL Namur Site de Godinne ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: +3281423858
    • Oost-Vlaanderen
      • Aalst, Oost-Vlaanderen, Belgium, 9300
        • Recruiting
        • O.L.V. Ziekenhuis Aalst ( Site 0106)
        • Contact:
          • Study Coordinator
          • Phone Number: +3253724378
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • UZ Gent ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: +3293322811
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares Gent ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +3292469522
  • Brazil
      • Sao Paulo, Brazil, 01321-001
        • Active, not recruiting
        • BP - A Beneficencia Portuguesa de São Paulo ( Site 1559)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60135-237
        • Active, not recruiting
        • Hospital São Carlos-Oncocentro Ce ( Site 1558)
    • Parana
      • Curitiba, Parana, Brazil, 81520060
        • Active, not recruiting
        • Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551)
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784400
        • Active, not recruiting
        • Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553)
      • São Paulo, Sao Paulo, Brazil, 04014-002
        • Active, not recruiting
        • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554)
      • São Paulo, Sao Paulo, Brazil, 01246-000
        • Completed
        • ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560)
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Recruiting
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
        • Contact:
          • Study Coordinator
          • Phone Number: 418525444420414
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2T 1X8
        • Active, not recruiting
        • Exdeo Clinical Research Inc. ( Site 0165)
      • Victoria, British Columbia, Canada, V8T 2C1
        • Completed
        • Silverado Resarch Inc. ( Site 0155)
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
        • Recruiting
        • Horizon Health Network ( Site 0160)
        • Contact:
          • Study Coordinator
          • Phone Number: 5068574780
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 0153)
        • Contact:
          • Study Coordinator
          • Phone Number: 4169462246
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Recruiting
        • CIUSSS du Saguenay-Lac-St-Jean ( Site 0164)
        • Contact:
          • Study Coordinator
          • Phone Number: 4185411000
      • Montreal, Quebec, Canada, H1T 2M4
        • Recruiting
        • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157)
        • Contact:
          • Study Coordinator
          • Phone Number: 5142523400x5766
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Recruiting
        • CHUS - Hopital Fleurimont ( Site 0152)
        • Contact:
          • Study Coordinator
          • Phone Number: 8193461110x12827
  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital-Urinary Surgery ( Site 1755)
        • Contact:
          • Study Coordinator
          • Phone Number: 13910571565
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital ( Site 1759)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613910688432
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766)
        • Contact:
          • Study Coordinator
          • Phone Number: 18601238866
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated hospital of Xiamen University-Urology ( Site 1776)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613806089889
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-87343392
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777)
        • Contact:
          • Study Coordinator
          • Phone Number: (8620) 34294311
      • Guangzhou, Guangdong, China, 510289
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751)
        • Contact:
          • Study Coordinator
          • Phone Number: 020-81332371
      • Shenzhen, Guangdong, China, 518020
        • Recruiting
        • ShenZhen People's Hospital ( Site 1778)
        • Contact:
          • Study Coordinator
          • Phone Number: 0755-25533018
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital-urology ( Site 1772)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613603612355
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital-Urology ( Site 1770)
        • Contact:
          • Study Coordinator
          • Phone Number: +8615981828716
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital ( Site 1771)
        • Contact:
          • Study Coordinator
          • Phone Number: 18602752025
      • Wuhan, Hubei, China, 430000
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology ( Site 1768)
        • Contact:
          • Study Coordinator
          • Phone Number: 13367255851
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 1763)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13207139095
    • Jiangsu
      • NanJing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
        • Contact:
          • Study Coordinator
          • Phone Number: +8602583106666
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University-Urology ( Site 1773)
        • Contact:
          • Study Coordinator
          • Phone Number: 18994392817
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 18149480558
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital Sichuan University ( Site 1767)
        • Contact:
          • Study Coordinator
          • Phone Number: （028）85164161
    • Tianjin
      • Tianjin, Tianjin, China, 300211
        • Recruiting
        • The Second Hospital of Tianjin Medical University ( Site 1769)
        • Contact:
          • Study Coordinator
          • Phone Number: 13662096232
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital-Urology ( Site 1762)
        • Contact:
          • Study Coordinator
          • Phone Number: 0571-85893008
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774)
        • Contact:
          • Study Coordinator
          • Phone Number: 0577-55579590
  • Colombia
    • Antioquia
      • Medellín, Antioquia, Colombia, 050024
        • Active, not recruiting
        • Instituto de Cancerología-Oncology ( Site 1609)
      • Rionegro, Antioquia, Colombia, 054047
        • Active, not recruiting
        • Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad
    • Cordoba
      • Montería, Cordoba, Colombia, 230002
        • Active, not recruiting
        • Oncomedica S.A.-Oncomedica S.A ( Site 1604)
    • Distrito Capital De Bogota
      • Bogota, Distrito Capital De Bogota, Colombia, 111321
        • Active, not recruiting
        • Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605)
      • Bogotá, Distrito Capital De Bogota, Colombia, 110221
        • Active, not recruiting
        • Administradora Country S.A. - Clinica del Country ( Site 1607)
    • Risaralda
      • Pereira, Risaralda, Colombia, 660001
        • Active, not recruiting
        • Oncologos del Occidente ( Site 1608)
    • Valle Del Cauca
      • Cali, Valle Del Cauca, Colombia, 76001
        • Completed
        • Hemato Oncologos SA-Oncology ( Site 1601)
      • Cali, Valle Del Cauca, Colombia, 760042
        • Active, not recruiting
        • Clínica Imbanaco S.A.S ( Site 1611)
  • Costa Rica
      • San Jose, Costa Rica, 10103
        • Active, not recruiting
        • Policlinico San Bosco ( Site 0600)
    • San Jose
      • San José, San Jose, Costa Rica, 10103
        • Active, not recruiting
        • CIMCA ( Site 1550)
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Active, not recruiting
        • Tampere University Hospital [Tampere Finland] ( Site 0201)
  • France
    • Bourgogne
      • Dijon, Bourgogne, France, 21000
        • Recruiting
        • Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355)
        • Contact:
          • Study Coordinator
          • Phone Number: 33380293761
    • Hauts-de-Seine
      • Suresnes, Hauts-de-Seine, France, 92150
        • Recruiting
        • Hôpital Foch-Urology department ( Site 1351)
        • Contact:
          • Study Coordinator
          • Phone Number: +33146251961
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35000
        • Recruiting
        • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353)
        • Contact:
          • Study Coordinator
          • Phone Number: 33299284270
    • Nord
      • Lille, Nord, France, 59037
        • Recruiting
        • Hopital Claude Huriez - CHU de Lille ( Site 1360)
        • Contact:
          • Study Coordinator
          • Phone Number: 0320444398
    • Seine-et-Marne
      • Créteil, Seine-et-Marne, France, 94000
        • Recruiting
        • HENRI MONDOR HOSPITAL ( Site 1357)
        • Contact:
          • Study Coordinator
          • Phone Number: +33145178243
  • Germany
    • Bayern
      • Munich, Bayern, Germany, 81675
        • Recruiting
        • Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266)
        • Contact:
          • Study Coordinator
          • Phone Number: +498941402522
      • Weiden In Der Oberpfalz, Bayern, Germany, 92637
        • Recruiting
        • Klinikum Weiden ( Site 0259)
        • Contact:
          • Study Coordinator
          • Phone Number: +49963033302
      • Wuerzburg, Bayern, Germany, 97080
        • Recruiting
        • Universitaetsklinikum Wuerzburg ( Site 0265)
        • Contact:
          • Study Coordinator
          • Phone Number: +4993120132037
    • Rheinland-Pfalz
      • Trier, Rheinland-Pfalz, Germany, 54292
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262)
        • Contact:
          • Study Coordinator
          • Phone Number: +496512082680
    • Thuringen
      • Jena, Thuringen, Germany, 07747
        • Recruiting
        • Universitaetsklinikum Jena ( Site 0252)
        • Contact:
          • Study Coordinator
          • Phone Number: +49-3641-9-329901
  • Greece
    • Achaia
      • Patra, Achaia, Greece, 265 04
        • Completed
        • General University Hospital of Patras ( Site 0302)
      • Patras, Achaia, Greece, 264 43
        • Recruiting
        • Olympion General Clinic ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +302610464064
    • Attiki
      • Chaidari, Attiki, Greece, 124 62
        • Recruiting
        • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: +302105831255
    • Kentriki Makedonia
      • Thessaloniki, Kentriki Makedonia, Greece, 54007
        • Completed
        • Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303)
    • Thessalia
      • Larissa, Thessalia, Greece, 411 10
        • Recruiting
        • University Hospital of Larissa ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +302413502811
  • Guatemala
      • Guatemala, Guatemala, 01010
        • Active, not recruiting
        • INTEGRA Cancer Institute ( Site 1451)
      • Guatemala, Guatemala, 01015
        • Active, not recruiting
        • Grupo Medico Angeles ( Site 1453)
      • Guatemala City, Guatemala, 01010
        • Active, not recruiting
        • Onco Go, S.A ( Site 1454)
  • Hungary
      • Budapest, Hungary, 1082
        • Recruiting
        • Semmelweis University-Urológiai Klinika ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: +36208258762
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: +36308544051
    • Baranya
      • Pécs, Baranya, Hungary, 7621
        • Recruiting
        • Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: 3672507323
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: +36709411312
  • Italy
      • Arezzo, Italy, 52100
        • Recruiting
        • Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363)
        • Contact:
          • Study Coordinator
          • Phone Number: +390575255436
      • Bari, Italy, 70124
        • Completed
        • Istituto Tumori Giovanni Paolo II ( Site 0357)
      • Genova, Italy, 16132
        • Completed
        • Ospedale San Martino ( Site 0351)
      • Palermo, Italy, 90123
        • Recruiting
        • Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352)
        • Contact:
          • Study Coordinator
          • Phone Number: +39091479432
      • Roma, Italy, 00168
        • Recruiting
        • Policlinico Universitario A. Gemelli ( Site 0358)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630154953
      • Verona, Italy, 37126
        • Recruiting
        • A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356)
        • Contact:
          • Study Coordinator
          • Phone Number: +390458123876
    • Abruzzo
      • Chieti, Abruzzo, Italy, 66100
        • Recruiting
        • Ospedale Clinicizzato Santissima Annunziata ( Site 0361)
        • Contact:
          • Study Coordinator
          • Phone Number: +390871357783
    • Milano
      • Milan, Milano, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353)
        • Contact:
          • Study Coordinator
          • Phone Number: +390223902402
    • Piemonte
      • Torino, Piemonte, Italy, 10128
        • Recruiting
        • Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0115082032
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Recruiting
        • Azienda Ospedaliero Universitaria Careggi ( Site 0360)
        • Contact:
          • Study Coordinator
          • Phone Number: +390557949920
    • Trentino-Sudtirol
      • Bolzano, Trentino-Sudtirol, Italy, 39100
        • Recruiting
        • Osp Generale Reg di Bolzano ( Site 0355)
        • Contact:
          • Study Coordinator
          • Phone Number: +390471908953
  • Japan
      • Chiba, Japan, 260-8717
        • Recruiting
        • Chiba Cancer Center ( Site 0401)
        • Contact:
          • Study Coordinator
          • Phone Number: +81432645431
      • Fukuoka, Japan, 812-0033
        • Recruiting
        • Harasanshin Hospital ( Site 0410)
        • Contact:
          • Study Coordinator
          • Phone Number: +81922913434
      • Osaka, Japan, 541-8567
        • Recruiting
        • Osaka International Cancer Institute ( Site 0413)
        • Contact:
          • Study Coordinator
          • Phone Number: +81669451181
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: +81666452121
      • Tokyo, Japan, 160-8582
        • Recruiting
        • Keio University Hospital ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: +81333531211
      • Tokyo, Japan, 113-8519
        • Recruiting
        • Tokyo Medical and Dental University Hospital ( Site 0409)
        • Contact:
          • Study Coordinator
          • Phone Number: +81338136111
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8563
        • Recruiting
        • Hirosaki University Hospital ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: +81172335111
    • Ehime
      • Toon, Ehime, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital ( Site 0414)
        • Contact:
          • Study Coordinator
          • Phone Number: +81899645111
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • Recruiting
        • University of Tsukuba Hospital ( Site 0412)
        • Contact:
          • Study Coordinator
          • Phone Number: +81298533900
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 0415)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: +81427788111
      • Yokosuka, Kanagawa, Japan, 238-8558
        • Recruiting
        • Yokosuka Kyosai Hospital ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: +81468222710
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Recruiting
        • Nara Medical University Hospital ( Site 0411)
        • Contact:
          • Study Coordinator
          • Phone Number: +81744223051
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital ( Site 0416)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-53-435-2111
  • Korea, Republic of
      • Seoul, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +821099288097
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +82220720361
      • Seoul, Korea, Republic of, 06351
        • Completed
        • Samsung Medical Center ( Site 0803)
    • Seoul
      • Songpagu, Seoul, Korea, Republic of, 05505
        • Completed
        • Asan Medical Center ( Site 0804)
  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • Completed
        • University Malaya Medical Centre ( Site 1180)
  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • Completed
        • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455)
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht University Medical Centre ( Site 0453)
        • Contact:
          • Study Coordinator
          • Phone Number: +31433876543
    • Zuid-Holland
      • Rotterdam, Zuid-Holland, Netherlands, 3015 GD
        • Recruiting
        • Erasmus MC ( Site 0451)
        • Contact:
          • Study Coordinator
          • Phone Number: +31107040704
  • Norway
    • Akershus
      • Lorenskog, Akershus, Norway, 1478
        • Recruiting
        • Akershus University Hospital ( Site 0553)
        • Contact:
          • Study Coordinator
          • Phone Number: +4767960000
    • Rogaland
      • Stavanger, Rogaland, Norway, 4011
        • Active, not recruiting
        • Stavanger universitetssykehus ( Site 0555)
  • Peru
      • Lima, Peru, 15076
        • Recruiting
        • Hospital Militar Central [Lima, Peru] ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +51997468543
    • Lima
      • La Victoria, Lima, Peru, 15033
        • Completed
        • Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601)
    • Muni Metro De Lima
      • Lima, Muni Metro De Lima, Peru, 15036
        • Recruiting
        • Oncosalud ( Site 0603)
        • Contact:
          • Study Coordinator
          • Phone Number: +51992756559
  • Poland
    • Dolnoslaskie
      • Wroclaw, Dolnoslaskie, Poland, 50-556
        • Recruiting
        • Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669)
        • Contact:
          • Study Coordinator
          • Phone Number: +48601143281
    • Kujawsko-pomorskie
      • Torun, Kujawsko-pomorskie, Poland, 87-100
        • Recruiting
        • Nasz Lekarz Przychodnie Medyczne ( Site 0679)
        • Contact:
          • Study Coordinator
          • Phone Number: +48563004380
    • Malopolskie
      • Krakow, Malopolskie, Poland, 30-510
        • Completed
        • Pratia MCM Krakow ( Site 0668)
      • Tarnow, Malopolskie, Poland, 33-100
        • Recruiting
        • Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681)
        • Contact:
          • Study Coordinator
          • Phone Number: +48728355694
    • Mazowieckie
      • Siedlce, Mazowieckie, Poland, 08-110
        • Completed
        • Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654)
      • Warsaw, Mazowieckie, Poland, 02-798
        • Recruiting
        • Medical Concierge Centrum Medyczne ( Site 0676)
        • Contact:
          • Study Coordinator
          • Phone Number: +48224166500
      • Warszawa, Mazowieckie, Poland, 01-748
        • Completed
        • Luxmed Onkologia sp. z o. o. ( Site 0653)
    • Podkarpackie
      • Przemysl, Podkarpackie, Poland, 37-700
        • Recruiting
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678)
        • Contact:
          • Study Coordinator
          • Phone Number: +48661957237
    • Pomorskie
      • Koscierzyna, Pomorskie, Poland, 83-400
        • Completed
        • Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671)
      • Slupsk, Pomorskie, Poland, 76-200
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655)
        • Contact:
          • Study Coordinator
          • Phone Number: +48598460340
    • Slaskie
      • Rybnik, Slaskie, Poland, 44-200
        • Completed
        • LIFTMED ( Site 0652)
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 61-731
        • Recruiting
        • Clinical Research Center Sp. z o.o. ( Site 0674)
        • Contact:
          • Study Coordinator
          • Phone Number: +48616632513
  • Portugal
      • Braga, Portugal, 4710-243
        • Active, not recruiting
        • 2CA Braga. Centro Clinico Academico ( Site 0705)
      • Coimbra, Portugal, 3000-075
        • Completed
        • Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704)
      • Lisboa, Portugal, 1998-018
        • Completed
        • Hospital CUF Descobertas ( Site 0706)
      • Lisboa, Portugal, 1099-023
        • Completed
        • Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708)
      • Lisboa, Portugal, 1649-035
        • Active, not recruiting
        • CHLN Hospital Santa Maria ( Site 0702)
      • Porto, Portugal, 4200-072
        • Recruiting
        • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225084000
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
        • Active, not recruiting
        • Advance Urology and Laparoscopic Center ( Site 0757)
      • Ponce, Puerto Rico, 00717
        • Active, not recruiting
        • Ad-Vance Medical Research ( Site 0756)
  • Spain
      • Barcelona, Spain, 08025
        • Recruiting
        • Fundacio Puigvert ( Site 0864)
        • Contact:
          • Study Coordinator
          • Phone Number: +34934169700
      • Madrid, Spain, 28007
        • Recruiting
        • Hospital Universitario Gregorio Maranon ( Site 0854)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914269070
      • Madrid, Spain, 28027
        • Completed
        • Clinica Universitaria Navarra - Madrid ( Site 0860)
      • Madrid, Spain, 28033
        • Recruiting
        • MD Anderson Cancer Center Madrid ( Site 0859)
        • Contact:
          • Study Coordinator
          • Phone Number: +34917878600
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal ( Site 0857)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913368263
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz ( Site 0866)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 912 071 876
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital La Fe de Valencia ( Site 0855)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961244188
    • La Coruna
      • Lugo, La Coruna, Spain, 27003
        • Recruiting
        • Hospital Universitario Lucus Augusti ( Site 0852)
        • Contact:
          • Study Coordinator
          • Phone Number: +34982296459
    • Madrid, Comunidad De
      • Pozuelo de Alarcon, Madrid, Comunidad De, Spain, 28223
        • Recruiting
        • Hospital Universitario Quiron Madrid ( Site 0862)
        • Contact:
          • Study Coordinator
          • Phone Number: +34914521987
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Completed
        • Clinica Universitaria de Navarra ( Site 0863)
  • Switzerland
      • Geneve, Switzerland, 1205
        • Recruiting
        • Hopitaux Universitaires de Geneve HUG ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +41223727876
      • Zurich, Switzerland, 8091
        • Recruiting
        • Universitaetsspital Zurich ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +41442555440
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4031
        • Recruiting
        • Universitaetsspital Basel ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: +41615565477
  • Taiwan
      • Taichung, Taiwan, 40447
        • Active, not recruiting
        • China Medical University Hospital-Department of Urology ( Site 1654)
      • Taichung, Taiwan, 407
        • Active, not recruiting
        • Taichung Veterans General Hospital ( Site 1653)
      • Taipei, Taiwan, 112
        • Active, not recruiting
        • Taipei Veterans General Hospital ( Site 1652)
  • Turkey
      • Ankara, Turkey, 06590
        • Recruiting
        • Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966)
        • Contact:
          • Study Coordinator
          • Phone Number: 0905337483275
      • Eskisehir, Turkey, 26480
        • Recruiting
        • Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953)
        • Contact:
          • Study Coordinator
          • Phone Number: +905327149696
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963)
        • Contact:
          • Study Coordinator
          • Phone Number: +905323430723
      • Istanbul, Turkey, 34385
        • Recruiting
        • Memorial Sisli Hastanesi-Medical Oncology ( Site 0965)
        • Contact:
          • Study Coordinator
          • Phone Number: +905325755400
      • Izmir, Turkey, 35340
        • Active, not recruiting
        • Dokuz Eylul Universitesi ( Site 0959)
      • Konya, Turkey, 42000
        • Recruiting
        • Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961)
        • Contact:
          • Study Coordinator
          • Phone Number: +905322679838
  • United Kingdom
    • Highland
      • Inverness, Highland, United Kingdom, IV2 3UJ
        • Recruiting
        • Raigmore Hospital ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +4401463706356
    • London, City Of
      • London, London, City Of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew s Hospital ( Site 1008)
        • Contact:
          • Study Coordinator
          • Phone Number: +442078828505
      • London, London, City Of, United Kingdom, SW17 0QT
        • Recruiting
        • St Georges University Hospitals NHS Foundation Trust. ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: +442087253362
  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Completed
        • Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083)
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic in Arizona - Phoenix ( Site 1094)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-342-6672
      • Tucson, Arizona, United States, 85704
        • Recruiting
        • Arizona Urology Specialists (AUS)-Professional Park ( Site 1096)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-618-1010
    • California
      • Los Angeles, California, United States, 90095
        • Completed
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
      • Orange, California, United States, 92868
        • Recruiting
        • University of California Irvine Medical Center ( Site 1061)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-456-8148
      • Torrance, California, United States, 90505
        • Recruiting
        • Genesis Research LLC ( Site 1065)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-602-5005
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Recruiting
        • Colorado Clinical Research ( Site 1100)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-996-9649
    • Florida
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Urological Research Network ( Site 1106)
        • Contact:
          • Study Coordinator
          • Phone Number: 786-431-2014
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic in Florida-Urology ( Site 1097)
        • Contact:
          • Study Coordinator
          • Phone Number: 904-953-7330
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-243-2177
      • Pensacola, Florida, United States, 32503
        • Completed
        • Woodlands Medical Specialists, PA ( Site 8002)
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory School of Medicine ( Site 1076)
        • Contact:
          • Study Coordinator
          • Phone Number: 404-778-4823
      • Roswell, Georgia, United States, 30076
        • Recruiting
        • Advanced Urology ( Site 1092)
        • Contact:
          • Study Coordinator
          • Phone Number: 678-344-8900
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-695-4484
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Active, not recruiting
        • Wichita Urology Group ( Site 1086)
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Recruiting
        • Ochsner LSU Health Shreveport - Regional Urology ( Site 1099)
        • Contact:
          • Study Coordinator
          • Phone Number: 318-683-0411
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System ( Site 1062)
        • Contact:
          • Study Coordinator
          • Phone Number: 313-916-8862
      • Troy, Michigan, United States, 48084
        • Recruiting
        • Michigan Institute of Urology ( Site 1077)
        • Contact:
          • Study Coordinator
          • Phone Number: 248-786-0467
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Completed
        • Coastal Urology Associates ( Site 1055)
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center ( Site 1090)
        • Contact:
          • Study Coordinator
          • Phone Number: 973-971-5373
      • New Brunswick, New Jersey, United States, 08903
        • Active, not recruiting
        • Rutgers Cancer Institute of New Jersey ( Site 1059)
    • New York
      • Albany, New York, United States, 12208
        • Completed
        • St. Peter's Hospital Cancer Care Center ( Site 1087)
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Monter Cancer Center ( Site 1080)
        • Contact:
          • Study Coordinator
          • Phone Number: 516-734-8500
      • New York, New York, United States, 10010
        • Recruiting
        • Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112)
        • Contact:
          • Study Coordinator
          • Phone Number: 2126867500 ext.6383
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-501-8206
      • Syracuse, New York, United States, 13210
        • Completed
        • Associated Medical Professionals of NY ( Site 1078)
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-841-7555
      • Cleveland, Ohio, United States, 44106
        • Completed
        • University Hospitals Cleveland Medical Center ( Site 1066)
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10
        • Contact:
          • Study Coordinator
          • Phone Number: 614-366-7421
    • Oregon
      • Portland, Oregon, United States, 97210
        • Completed
        • OHSU Knight Cancer Institute ( Site 1075)
      • Springfield, Oregon, United States, 97477
        • Recruiting
        • Oregon Urology Institute ( Site 1098)
        • Contact:
          • Study Coordinator
          • Phone Number: 541-284-5508
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic Urology ( Site 1071)
        • Contact:
          • Study Coordinator
          • Phone Number: 610-667-0458
      • Lancaster, Pennsylvania, United States, 17604
        • Recruiting
        • Lancaster Urology ( Site 1079)
        • Contact:
          • Study Coordinator
          • Phone Number: 717-431-2285
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania ( Site 1088)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-662-2891
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center ( Site 1085)
        • Contact:
          • Study Coordinator
          • Phone Number: 8434491010257
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates [Nashville, TN] ( Site 1072)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-250-9268
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Urology Clinics of North Texas, PLLC ( Site 1064)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-580-1485
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University Of Texas Southwestern Medical Center ( Site 1053)
        • Contact:
          • Study Coordinator
          • Phone Number: 214-645-8787
      • Fort Worth, Texas, United States, 76104
        • Completed
        • Texas Oncology-Fort Worth Cancer Center ( Site 8003)
      • Houston, Texas, United States, 77027
        • Recruiting
        • Houston Metro Urology ( Site 1111)
        • Contact:
          • Study Coordinator
          • Phone Number: 832-549-4395
      • Plano, Texas, United States, 75093
        • Completed
        • Texas Oncology-Plano West ( Site 8001)
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Urology San Antonio Research ( Site 1108)
        • Contact:
          • Study Coordinator
          • Phone Number: 832-472-5482
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center ( Site 1057)
        • Contact:
          • Study Coordinator
          • Phone Number: 802-656-9926
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Recruiting
        • Urology of Virginia ( Site 1070)
        • Contact:
          • Study Coordinator
          • Phone Number: 757-452-3463

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: BCG
BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
Other Names:
  • TICE® BCG
  • OncoTICE®
Experimental: BCG Monotherapy: Post-induction Cohort A (Arm A-2)
Participants receive BCG monotherapy (Induction and Maintenance).
Biological: BCG
BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
Other Names:
  • TICE® BCG
  • OncoTICE®
Experimental: 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).
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
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: BCG
BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
Other Names:
  • TICE® BCG
  • OncoTICE®
Experimental: 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).
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
Other Names:
  • MK-3475
  • KEYTRUDA®
Biological: BCG
BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
Other Names:
  • TICE® BCG
  • OncoTICE®
Experimental: BCG Monotherapy: BCG Naïve Cohort B (Arm B-3)
Participants receive BCG monotherapy (Induction and Maintenance).
Biological: BCG
BCG (intravesical instillation): powder for instillation fluid for intravesical use, administered during Induction and Maintenance therapy
Other Names:
  • TICE® BCG
  • OncoTICE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR) by Blinded Independent Central Review (BICR) (Cohort A)
Time Frame: Up to ~3.5 years
CRR is defined as the percentage of participants with CIS achieving a complete response (CR).
Up to ~3.5 years
Event-Free Survival (EFS) (Cohort B)
Time Frame: Up to ~5 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
EFS (Cohort A)
Time Frame: Up to ~5 years
EFS is defined as the time from randomization until UC-defined event, or death due to any cause.
Up to ~5 years
Recurrence-Free Survival (RFS) (Cohorts A and B)
Time Frame: Up to ~5 years
RFS is defined as the time from randomization until the first occurrence of any UC recurrence, progression, or death due to any cause.
Up to ~5 years
Overall Survival (OS) (Cohorts A and B)
Time Frame: Up to ~5 years
OS is defined as the time from randomization to death due to any cause.
Up to ~5 years
Disease Specific Survival (DSS) (Cohorts A and B)
Time Frame: Up to ~5 years
DSS is defined as the time from randomization to death due to bladder cancer.
Up to ~5 years
Time to Cystectomy (Cohorts A and B)
Time Frame: Up to ~5 years
Time to cystectomy is defined as the time from a participant's randomization until the date of cystectomy.
Up to ~5 years
12-Month EFS Rate (Cohort A)
Time Frame: 12 months after EFS (up to ~5 years)
EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 12-month EFS rate is defined as the percentage of participants with EFS at 12 months.
12 months after EFS (up to ~5 years)
Duration of Response (DOR) (Cohorts A and B)
Time Frame: Up to ~5 years
DOR is defined as the time from first documented CR until end of response or death due to any cause, whichever occurs first.
Up to ~5 years
12-Month DOR Rate (Cohorts A and B)
Time Frame: 12 months after CR (up to ~4.5 years)
The 12-month DOR Rate is defined as the percentage of participants with a CR of at least 12 months duration.
12 months after CR (up to ~4.5 years)
Percentage of Participants Experiencing Adverse Events (AEs) (Cohorts A and B)
Time Frame: Up to ~5 years
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Up to ~5 years
Percentage of Participants Discontinuing Study Drug Due to AEs (Cohorts A and B)
Time Frame: Up to ~5 years
An AE is any untoward medical occurrence in a participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment.
Up to ~5 years
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)
Time Frame: Baseline, time of last PRO assessment (up to ~2 years)
The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. The change from baseline in Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
Baseline, time of last PRO assessment (up to ~2 years)
Change from Baseline in EORTC-QLQ-C30 Physical Functioning (Items 1-5) Combined Score (Cohorts A and B)
Time Frame: Baseline, time of last PRO assessment (up to ~2 years)
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better quality of life. The change from baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) combined score will be presented.
Baseline, time of last PRO assessment (up to ~2 years)
Change from Baseline in EORTC-QLQ-Non-muscle Invasive Bladder Cancer Module 24 (NMIBC24) Total Score (Cohorts A and B)
Time Frame: Baseline, time of last PRO assessment (up to ~2 years)
The EORTC-QLQ-NMIBC24 is a 24-item questionnaire developed to supplement the EORTC QLQ-C30 in high-risk NMIBC patients. Each item is scored out of 4 total points (1=Not at All to 4=Very Much). All responses are transformed from 0 to 100, with a high score indicating more symptoms or problems. The change from baseline in EORTC-QLQ-NMIBC24 total score will be presented.
Baseline, time of last PRO assessment (up to ~2 years)
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)
Time Frame: Baseline, time of last PRO assessment (up to ~2 years)
The EQ-5D-5L VAS records the respondent's self-rated health on a 10 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". The change from baseline in EQ-5D-5L VAS will be presented.
Baseline, time of last PRO assessment (up to ~2 years)
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)
Time Frame: Time of last PRO assessment (up to ~2 years)
EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall outcome. TTD in Global Health Status/Quality of Life is defined as the time from baseline to the first onset of a 10 point or greater decrease from baseline in the Global Health Status/Quality of Life (EORTC QLQ-C30 Items 29 and 30) combined score, with or without subsequent confirmation.
Time of last PRO assessment (up to ~2 years)
TTD in the EQ-5D-5L VAS (Cohorts A and B)
Time Frame: Time of last PRO assessment (up to ~2 years)
The EQ-5D-5L VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine". TTD in EQ-5D-5L VAS is defined as the time from baseline to the first onset of a 7 point or greater decrease from baseline in EQ-5D-5L VAS, with or without subsequent confirmation, under a right-censoring rule.
Time of last PRO assessment (up to ~2 years)
CRR by BICR (Cohort B)
Time Frame: Up to ~3.5 years
CRR is defined as the percentage of participants with CIS achieving a CR.
Up to ~3.5 years
24-Month EFS Rate (Cohort B)
Time Frame: 24 months after EFS (Up to ~5 years)
EFS is defined as the time from randomization until UC-defined event, or death due to any cause. The 24-month EFS rate is defined as the percentage of participants with EFS at 24 months.
24 months after EFS (Up to ~5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

October 12, 2028

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

October 16, 2018

First Posted (Actual)

October 18, 2018

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475-676
  • MK-3475-676 (Other Identifier: Merck Protocol Number)
  • 194713 (Other Identifier: JAPIC-CTI)
  • 2018-001967-22 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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