Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in High-Risk Non-Muscle Invasive Bladder Cancer (HR NMIBC) (MK-3475-676/KEYNOTE-676)
Official Title: A Phase 3, Randomized, Comparator-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Bacillus Calmette-Guerin (BCG) in Participants With High-risk Non-muscle Invasive Bladder Cancer (HR NMIBC) That is Either Persistent or Recurrent Following BCG Induction or That is Naïve to BCG Treatment (KEYNOTE-676)
Study ID: NCT03711032
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alaska Urological Institute dba Alaska Clinical Research Center ( Site 1083), Anchorage, Alaska, United States
Mayo Clinic in Arizona - Phoenix ( Site 1094), Phoenix, Arizona, United States
Arizona Urology Specialists (AUS)-Professional Park ( Site 1096), Tucson, Arizona, United States
UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro, Los Angeles, California, United States
University of California Irvine Medical Center ( Site 1061), Orange, California, United States
Genesis Research LLC ( Site 1065), Torrance, California, United States
Colorado Clinical Research ( Site 1100), Lakewood, Colorado, United States
Urological Research Network ( Site 1106), Hialeah, Florida, United States
Mayo Clinic in Florida-Urology ( Site 1097), Jacksonville, Florida, United States
University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1056), Miami, Florida, United States
Woodlands Medical Specialists, PA ( Site 8002), Pensacola, Florida, United States
Emory School of Medicine ( Site 1076), Atlanta, Georgia, United States
Advanced Urology ( Site 1092), Roswell, Georgia, United States
Northwestern Memorial Hospital ( Site 1101), Chicago, Illinois, United States
Wichita Urology Group ( Site 1086), Wichita, Kansas, United States
Ochsner LSU Health Shreveport - Regional Urology ( Site 1099), Shreveport, Louisiana, United States
Henry Ford Health System ( Site 1062), Detroit, Michigan, United States
Michigan Institute of Urology ( Site 1077), Troy, Michigan, United States
Coastal Urology Associates ( Site 1055), Brick, New Jersey, United States
Morristown Medical Center ( Site 1090), Morristown, New Jersey, United States
Rutgers Cancer Institute of New Jersey ( Site 1059), New Brunswick, New Jersey, United States
St. Peter's Hospital Cancer Care Center ( Site 1087), Albany, New York, United States
Monter Cancer Center ( Site 1080), Lake Success, New York, United States
Veterans Affairs New York Harbor Healthcare System-PCF COE ( Site 1112), New York, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 1074), New York, New York, United States
Associated Medical Professionals of NY ( Site 1078), Syracuse, New York, United States
TriState Urologic Services PSC Inc. dba The Urology Group ( Site 1091), Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center ( Site 1066), Cleveland, Ohio, United States
Ohio State University Arthur G James Cancer Hospital & Richard J Solove Research Institute ( Site 10, Columbus, Ohio, United States
OHSU Knight Cancer Institute ( Site 1075), Portland, Oregon, United States
Oregon Urology Institute ( Site 1098), Springfield, Oregon, United States
MidLantic Urology ( Site 1071), Bala-Cynwyd, Pennsylvania, United States
Lancaster Urology ( Site 1079), Lancaster, Pennsylvania, United States
University of Pennsylvania ( Site 1088), Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center ( Site 1085), Myrtle Beach, South Carolina, United States
Urology Associates [Nashville, TN] ( Site 1072), Nashville, Tennessee, United States
Urology Clinics of North Texas, PLLC ( Site 1064), Dallas, Texas, United States
University Of Texas Southwestern Medical Center ( Site 1053), Dallas, Texas, United States
Texas Oncology-Fort Worth Cancer Center ( Site 8003), Fort Worth, Texas, United States
Houston Metro Urology ( Site 1111), Houston, Texas, United States
Texas Oncology-Plano West ( Site 8001), Plano, Texas, United States
Urology San Antonio Research ( Site 1108), San Antonio, Texas, United States
University of Vermont Medical Center ( Site 1057), Burlington, Vermont, United States
Urology of Virginia ( Site 1070), Virginia Beach, Virginia, United States
GenesisCare North Shore ( Site 0010), St Leonards, New South Wales, Australia
Northern Cancer Institute. ( Site 0003), St Leonards, New South Wales, Australia
Sydney Adventist Hospital ( Site 0001), Wahroonga, New South Wales, Australia
Epworth Hospital ( Site 0009), Richmond, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen ( Site 0052), Linz, Oberosterreich, Austria
Univ. Klinik f. Urologie Innsbruck ( Site 0051), Innsbruck, Tirol, Austria
Medizinische Universität Wien ( Site 0054), Vienna, Wien, Austria
Universitaetsklinik Salzburg ( Site 0053), Salzburg, , Austria
UZA University Hospital Antwerp ( Site 0105), Edegem, Antwerpen, Belgium
CHU UCL Namur Site de Godinne ( Site 0103), Yvoir, Namur, Belgium
O.L.V. Ziekenhuis Aalst ( Site 0106), Aalst, Oost-Vlaanderen, Belgium
AZ Maria Middelares Gent ( Site 0102), Gent, Oost-Vlaanderen, Belgium
UZ Gent ( Site 0101), Gent, Oost-Vlaanderen, Belgium
Hospital São Carlos-Oncocentro Ce ( Site 1558), Fortaleza, Ceara, Brazil
Hospital Erasto Gaertner-CEPEP - Pesquisa Clínica ( Site 1551), Curitiba, Parana, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos-Unidade de Pesquisa Clínica ( Site 1553), Barretos, Sao Paulo, Brazil
ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 1560), São Paulo, Sao Paulo, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 1554), São Paulo, Sao Paulo, Brazil
BP - A Beneficencia Portuguesa de São Paulo ( Site 1559), Sao Paulo, , Brazil
Exdeo Clinical Research Inc. ( Site 0165), Abbotsford, British Columbia, Canada
Silverado Resarch Inc. ( Site 0155), Victoria, British Columbia, Canada
Horizon Health Network ( Site 0160), Moncton, New Brunswick, Canada
Princess Margaret Cancer Centre ( Site 0153), Toronto, Ontario, Canada
CIUSSS du Saguenay-Lac-St-Jean ( Site 0164), Chicoutimi, Quebec, Canada
CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0157), Montreal, Quebec, Canada
CHUS - Hopital Fleurimont ( Site 0152), Sherbrooke, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Quebec, , Canada
Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 1766), Beijing, Beijing, China
Peking University First Hospital ( Site 1759), Beijing, Beijing, China
Beijing Cancer hospital-Urinary Surgery ( Site 1755), Beijing, Beijing, China
The First Affiliated hospital of Xiamen University-Urology ( Site 1776), Xiamen, Fujian, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 1752), Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 1777), Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 1751), Guangzhou, Guangdong, China
ShenZhen People's Hospital ( Site 1778), Shenzhen, Guangdong, China
Harbin Medical University Cancer Hospital-urology ( Site 1772), Harbin, Heilongjiang, China
Henan Cancer Hospital-Urology ( Site 1770), Zhengzhou, Henan, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 1768), Wuhan, Hubei, China
Wuhan Union Hospital ( Site 1771), Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 1763), Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S, NanJing, Jiangsu, China
The Second Affiliated Hospital of Soochow University-Urology ( Site 1773), Suzhou, Jiangsu, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 1764), Xi'an, Shaanxi, China
West China Hospital Sichuan University ( Site 1767), Cheng Du, Sichuan, China
The Second Hospital of Tianjin Medical University ( Site 1769), Tianjin, Tianjin, China
Zhejiang Provincial People's Hospital-Urology ( Site 1762), Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 1774), Wenzhou, Zhejiang, China
Instituto de Cancerología-Oncology ( Site 1609), Medellín, Antioquia, Colombia
Fundación Hospital San Vicente de Paúl - Rionegro - Centros Especializados o de Centros Especializad, Rionegro, Antioquia, Colombia
Oncomedica S.A.-Oncomedica S.A ( Site 1604), Montería, Cordoba, Colombia
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1605), Bogota, Distrito Capital De Bogota, Colombia
Administradora Country S.A. - Clinica del Country ( Site 1607), Bogotá, Distrito Capital De Bogota, Colombia
Oncologos del Occidente ( Site 1608), Pereira, Risaralda, Colombia
Hemato Oncologos SA-Oncology ( Site 1601), Cali, Valle Del Cauca, Colombia
Clínica Imbanaco S.A.S ( Site 1611), Cali, Valle Del Cauca, Colombia
CIMCA ( Site 1550), San José, San Jose, Costa Rica
Policlinico San Bosco ( Site 0600), San Jose, , Costa Rica
Tampere University Hospital [Tampere Finland] ( Site 0201), Tampere, Pirkanmaa, Finland
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand-Urology ( Site 1355), Dijon, Bourgogne, France
Hôpital Foch-Urology department ( Site 1351), Suresnes, Hauts-de-Seine, France
Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 1353), Rennes, Ille-et-Vilaine, France
Hopital Claude Huriez - CHU de Lille ( Site 1360), Lille, Nord, France
HENRI MONDOR HOSPITAL ( Site 1357), Créteil, Seine-et-Marne, France
Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0266), Munich, Bayern, Germany
Klinikum Weiden ( Site 0259), Weiden In Der Oberpfalz, Bayern, Germany
Universitaetsklinikum Wuerzburg ( Site 0265), Wuerzburg, Bayern, Germany
Krankenhaus der Barmherzigen Brüder Trier-Abteilung für Urologie und Kinderurologie ( Site 0262), Trier, Rheinland-Pfalz, Germany
Universitaetsklinikum Jena ( Site 0252), Jena, Thuringen, Germany
Olympion General Clinic ( Site 0306), Patras, Achaia, Greece
General University Hospital of Patras ( Site 0302), Patra, Achaia, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 0304), Chaidari, Attiki, Greece
Antikarkiniko Nosokomeio Thessalonikis THEAGENIO ( Site 0303), Thessaloniki, Kentriki Makedonia, Greece
University Hospital of Larissa ( Site 0301), Larissa, Thessalia, Greece
Onco Go, S.A ( Site 1454), Guatemala City, , Guatemala
INTEGRA Cancer Institute ( Site 1451), Guatemala, , Guatemala
Grupo Medico Angeles ( Site 1453), Guatemala, , Guatemala
Pécsi Tudományegyetem Klinikai Központ-Urológiai Klinika ( Site 1304), Pécs, Baranya, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Urológiai Klinika ( Site 1303), Szeged, Csongrad, Hungary
Semmelweis University-Urológiai Klinika ( Site 1301), Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 1302), Debrecen, , Hungary
Ospedale Clinicizzato Santissima Annunziata ( Site 0361), Chieti, Abruzzo, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0353), Milan, Milano, Italy
Ospedale Mauriziano-SCDU ONCOLOGIA MEDICA ( Site 0366), Torino, Piemonte, Italy
Azienda Ospedaliero Universitaria Careggi ( Site 0360), Firenze, Toscana, Italy
Osp Generale Reg di Bolzano ( Site 0355), Bolzano, Trentino-Sudtirol, Italy
Azienda USL 8 di Arezzo-Medical Oncology ( Site 0363), Arezzo, , Italy
Istituto Tumori Giovanni Paolo II ( Site 0357), Bari, , Italy
Ospedale San Martino ( Site 0351), Genova, , Italy
IRCCS Ospedale San Raffaele ( Site 0362), Milano, , Italy
Ospedale Buccheri La Ferla Fatebenefratelli ( Site 0352), Palermo, , Italy
Policlinico Universitario A. Gemelli ( Site 0358), Roma, , Italy
A.O.U. di Verona - Ospedale Civile Maggiore Borgo Trento ( Site 0356), Verona, , Italy
Hirosaki University Hospital ( Site 0407), Hirosaki, Aomori, Japan
Ehime University Hospital ( Site 0414), Toon, Ehime, Japan
University of Tsukuba Hospital ( Site 0412), Tsukuba, Ibaraki, Japan
St. Marianna University Hospital ( Site 0415), Kawasaki, Kanagawa, Japan
Kitasato University Hospital ( Site 0403), Sagamihara, Kanagawa, Japan
Yokosuka Kyosai Hospital ( Site 0406), Yokosuka, Kanagawa, Japan
Nara Medical University Hospital ( Site 0411), Kashihara, Nara, Japan
Hamamatsu University Hospital ( Site 0416), Hamamatsu, Shizuoka, Japan
Chiba Cancer Center ( Site 0401), Chiba, , Japan
Harasanshin Hospital ( Site 0410), Fukuoka, , Japan
Osaka International Cancer Institute ( Site 0413), Osaka, , Japan
Osaka Metropolitan University Hospital ( Site 0404), Osaka, , Japan
Tokyo Medical and Dental University Hospital ( Site 0409), Tokyo, , Japan
Keio University Hospital ( Site 0405), Tokyo, , Japan
Asan Medical Center ( Site 0804), Songpagu, Seoul, Korea, Republic of
Korea University Anam Hospital ( Site 0801), Seoul, , Korea, Republic of
Seoul National University Hospital ( Site 0802), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0803), Seoul, , Korea, Republic of
University Malaya Medical Centre ( Site 1180), Kuala Lumpur, , Malaysia
Maastricht University Medical Centre ( Site 0453), Maastricht, Limburg, Netherlands
Erasmus MC ( Site 0451), Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 0455), Utrecht, , Netherlands
Akershus University Hospital ( Site 0553), Lorenskog, Akershus, Norway
Stavanger universitetssykehus ( Site 0555), Stavanger, Rogaland, Norway
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0601), La Victoria, Lima, Peru
Oncosalud ( Site 0603), Lima, Muni Metro De Lima, Peru
Hospital Militar Central [Lima, Peru] ( Site 0604), Lima, , Peru
Uniwesytecki Szpital Kliniczny we Wroclawiu ( Site 0669), Wroclaw, Dolnoslaskie, Poland
MICS Centrum Medyczne Torun ( Site 0679), Torun, Kujawsko-pomorskie, Poland
Pratia MCM Krakow ( Site 0668), Krakow, Malopolskie, Poland
Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 0681), Tarnow, Malopolskie, Poland
Urologica Praktyka Lekarska Adam Marcheluk ( Site 0654), Siedlce, Mazowieckie, Poland
Medical Concierge Centrum Medyczne ( Site 0676), Warsaw, Mazowieckie, Poland
Luxmed Onkologia sp. z o. o. ( Site 0653), Warszawa, Mazowieckie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 0678), Przemysl, Podkarpackie, Poland
Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 0671), Koscierzyna, Pomorskie, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku ( Site 0655), Slupsk, Pomorskie, Poland
LIFTMED ( Site 0652), Rybnik, Slaskie, Poland
Clinical Research Center Sp. z o.o. ( Site 0674), Poznan, Wielkopolskie, Poland
2CA Braga. Centro Clinico Academico ( Site 0705), Braga, , Portugal
Inst. Portugues de Oncologia de Coimbra Francisco Gentil EPE ( Site 0704), Coimbra, , Portugal
Inst. Portugues de Oncologia de Lisboa Francisco Gentil EPE ( Site 0708), Lisboa, , Portugal
CHLN Hospital Santa Maria ( Site 0702), Lisboa, , Portugal
Hospital CUF Descobertas ( Site 0706), Lisboa, , Portugal
Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0701), Porto, , Portugal
Advance Urology and Laparoscopic Center ( Site 0757), Ponce, , Puerto Rico
Ad-Vance Medical Research ( Site 0756), Ponce, , Puerto Rico
Hospital Universitario Lucus Augusti ( Site 0852), Lugo, La Coruna, Spain
Hospital Universitario Quiron Madrid ( Site 0862), Pozuelo de Alarcon, Madrid, Comunidad De, Spain
Clinica Universitaria de Navarra ( Site 0863), Pamplona, Navarra, Spain
Fundacio Puigvert ( Site 0864), Barcelona, , Spain
Hospital Universitario Gregorio Maranon ( Site 0854), Madrid, , Spain
Clinica Universitaria Navarra - Madrid ( Site 0860), Madrid, , Spain
MD Anderson Cancer Center Madrid ( Site 0859), Madrid, , Spain
Hospital Universitario Ramon y Cajal ( Site 0857), Madrid, , Spain
Hospital Universitario La Paz ( Site 0866), Madrid, , Spain
Hospital La Fe de Valencia ( Site 0855), Valencia, , Spain
Universitaetsspital Basel ( Site 1201), Basel, Basel-Stadt, Switzerland
Hopitaux Universitaires de Geneve HUG ( Site 1204), Geneve, , Switzerland
Universitaetsspital Zurich ( Site 1203), Zurich, , Switzerland
China Medical University Hospital-Department of Urology ( Site 1654), Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 1653), Taichung, , Taiwan
Taipei Veterans General Hospital ( Site 1652), Taipei, , Taiwan
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 0966), Ankara, , Turkey
Eskisehir Osmangazi Universitesi Hastanesi ( Site 0953), Eskisehir, , Turkey
Memorial Sisli Hastanesi-Medical Oncology ( Site 0965), Istanbul, , Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 0963), Istanbul, , Turkey
Dokuz Eylul Universitesi ( Site 0959), Izmir, , Turkey
Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0961), Konya, , Turkey
Raigmore Hospital ( Site 1006), Inverness, Highland, United Kingdom
St Bartholomew s Hospital ( Site 1008), London, London, City Of, United Kingdom
St Georges University Hospitals NHS Foundation Trust. ( Site 1005), London, London, City Of, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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