Spots Global Cancer Trial Database for Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
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Trial Identification
Brief Title: Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Muscle-invasive Bladder Cancer (MIBC) (MK-3475-992/KEYNOTE-992)
Official Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Chemoradiotherapy (CRT) Versus CRT Alone in Participants With Muscle-invasive Bladder Cancer (MIBC) (KEYNOTE-992)
Study ID: NCT04241185
Conditions
Study Description
Brief Summary: This study is designed to assess the antitumor efficacy and safety of pembrolizumab in combination with chemoradiotherapy (CRT) versus CRT alone in participants with muscle-invasive bladder cancer (MIBC). The primary hypothesis is that pembrolizumab + chemoradiotherapy is superior to placebo + chemoradiotherapy with respect to bladder intact event-free survival.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Washington Cancer Institute at MedStar Washington Hospital Center ( Site 0041), Washington, District of Columbia, United States
Bay Pines VA Medical Center ( Site 0055), Bay Pines, Florida, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0004), Orlando, Florida, United States
Norton Cancer Institute ( Site 0044), Louisville, Kentucky, United States
Pikeville Medical Center ( Site 0009), Pikeville, Kentucky, United States
Baltimore VA Medical Center ( Site 0054), Baltimore, Maryland, United States
Washington University ( Site 0003), Saint Louis, Missouri, United States
Summit Medical Group Cancer Center ( Site 6008), Florham Park, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0005), Hackensack, New Jersey, United States
New York Oncology Hematology P.C ( Site 0024), Albany, New York, United States
Roswell Park Cancer Institute ( Site 6009), Buffalo, New York, United States
Winthrop University Hospital ( Site 0069), Mineola, New York, United States
New York University Perlmutter Cancer Center ( Site 0001), New York, New York, United States
Cleveland Clinic Main ( Site 0062), Cleveland, Ohio, United States
MidLantic urology ( Site 0070), Bala-Cynwyd, Pennsylvania, United States
Saint Francis Cancer Center ( Site 0026), Greenville, South Carolina, United States
Carolina Urologic Research Center ( Site 0002), Myrtle Beach, South Carolina, United States
Urology San Antonio Research ( Site 6010), San Antonio, Texas, United States
Inova Schar Cancer Institute ( Site 6006), Fairfax, Virginia, United States
West Virginia University - Charleston Area Medical Center ( Site 6003), Charleston, West Virginia, United States
Froedtert and Medical College of Wisconsin ( Site 0022), Milwaukee, Wisconsin, United States
Liverpool Hospital ( Site 0220), Liverpool, New South Wales, Australia
GenesisCare North Shore ( Site 0217), St Leonards, New South Wales, Australia
Monash Medical Centre ( Site 0216), Clayton, Victoria, Australia
Austin Health ( Site 0218), Heidelberg, Victoria, Australia
Sir Charles Gairdner Hospital ( Site 0223), Nedlands, Western Australia, Australia
Oncocentro Valdivia ( Site 7055), Valdivia, Los Rios, Chile
FALP ( Site 7056), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 7051), Santiago, Region M. De Santiago, Chile
ONCOCENTRO APYS-ACEREY ( Site 7054), Viña del Mar, Valparaiso, Chile
Bradford Hill Norte ( Site 7052), Antofagasta, , Chile
Fakultni nemocnice Olomouc ( Site 0559), Olomouc, , Czechia
2. LF UK a FN Motol ( Site 0555), Praha 5, , Czechia
Nemocnice Na Bulovce ( Site 0556), Praha 8, , Czechia
Herlev og Gentofte Hospital. ( Site 0401), Herlev, Hovedstaden, Denmark
Odense Universitetshospital ( Site 0403), Odense, Syddanmark, Denmark
North Estonia Medical Centre Foundation ( Site 0081), Tallin, Harjumaa, Estonia
Tartu University Hospital ( Site 0079), Tartu, Tartumaa, Estonia
Institut Sainte Catherine ( Site 0121), Avignon, Provence-Alpes-Cote-d Azur, France
CHU Amiens Picardie Site Sud Amiens ( Site 0123), Amiens, Somme, France
Institut Curie ( Site 0112), Paris, , France
A.P.H. Paris. Hopital Bichat Claude Bernard ( Site 0115), Paris, , France
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0146), Guatemala, , Guatemala
Oncomedica ( Site 0145), Guatemala, , Guatemala
Grupo Medico Angeles ( Site 0143), Guatemala, , Guatemala
Medi-K Cayala ( Site 0142), Guatemala, , Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 0144), Quetzaltenango, , Guatemala
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 0095), Kecskemét, Bacs-Kiskun, Hungary
BAZ Megyei Korhaz. Klinikai Onkologia es Sugarterapias Centrum ( Site 0092), Miskolc, Borsod-Abauj-Zemplen, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 0099), Gyor, Gyor-Moson-Sopron, Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0097), Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0091), Kaposvar, , Hungary
Soroka Medical Center-Oncology ( Site 7031), Be'er Sheva, , Israel
Rambam Health Care Campus-Oncology Division ( Site 0088), Haifa, , Israel
Hadassah Medical Center. Ein Kerem ( Site 0086), Jerusalem, , Israel
Rabin Medical Center ( Site 7032), Petah Tikva, , Israel
Chaim Sheba Medical Center ( Site 0087), Ramat Gan, , Israel
Sourasky Medical Center ( Site 0089), Tel Aviv, , Israel
Fondazione Policlinico Universitario Campus Bio-Medico-Radiation Oncology ( Site 7041), Roma, Lazio, Italy
Ospedale San Raffaele ( Site 0194), Milano, Lombardia, Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0193), Bari, Puglia, Italy
AOU Careggi ( Site 0191), Firenze, , Italy
Ospedale Civile di Macerata ( Site 0190), Macerata, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0186), Milano, , Italy
Azienda Ospedaliero - Universitaria Policlinico di Modena ( Site 0188), Modena, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0192), Napoli, , Italy
Hirosaki University Hospital ( Site 0602), Hirosaki, Aomori, Japan
University of Tsukuba Hospital ( Site 0605), Tsukuba, Ibaraki, Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 0604), Takatsuki, Osaka, Japan
Nagasaki University Hospital ( Site 0600), Nagasaki, , Japan
Tokyo Medical and Dental University Hospital ( Site 0601), Tokyo, , Japan
Tokyo Metropolitan Komagome Hospital ( Site 0606), Tokyo, , Japan
National Cancer Center ( Site 0202), Gyeonggi-do, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0204), Seongnam-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 0200), Songpagu, Seoul, Korea, Republic of
Chungnam National University Hospital ( Site 0203), Daejeon, Taejon-Kwangyokshi, Korea, Republic of
Korea University Anam Hospital ( Site 0205), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0201), Seoul, , Korea, Republic of
Pauls Stradins Clinical University Hospital ( Site 0073), Riga, , Latvia
Hospital Universiti Sains Malaysia ( Site 0237), Kubang Kerian, Kelantan, Malaysia
Hospital Pulau Pinang ( Site 0239), Penang, Pulau Pinang, Malaysia
Hospital Kuala Lumpur ( Site 0238), Kuala Lumpur, , Malaysia
University Malaya Medical Centre ( Site 0236), Kuala Lumpur, , Malaysia
Netherlands Cancer Institute (NKI) ( Site 0183), Amsterdam, Noord-Holland, Netherlands
Erasmus MC ( Site 0182), Rotterdam, Zuid-Holland, Netherlands
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0153), Krakow, Malopolskie, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach ( Site 0154), Siedlce, Mazowieckie, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 0152), Koszalin, Zachodniopomorskie, Poland
Hospital Beatriz Angelo ( Site 0303), Loures, Lisboa, Portugal
Centro Hospitalar e Universitario de Coimbra ( Site 0306), Coimbra, , Portugal
CHLO, EPE - Hospital de Sao Francisco Xavier ( Site 0302), Lisboa, , Portugal
Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria ( Site 0305), Lisboa, , Portugal
Advance Urology and Laparoscopic Center ( Site 0281), Ponce, , Puerto Rico
PAN American Center Oncologic ( Site 0280), San Juan, Rio Piedras, , Puerto Rico
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 0249), Cluj Napoca, Cluj, Romania
S.C. Radiotherapy Center Cluj S.R.L ( Site 0252), Cluj-Napoca, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 0248), Craiova, Dolj, Romania
Policlinica Oncomed SRL ( Site 0254), Timisoara, Timis, Romania
S.C.Focus Lab Plus S.R.L ( Site 0253), Bucuresti, , Romania
Institutul Oncologic-Oncologie Medicala ( Site 0256), Cluj, , Romania
Institutul Regional de Oncologie Iasi ( Site 0255), Iasi, , Romania
Instituto Catalan de Oncologia - ICO ( Site 0103), L Hospitalet De Llobregat, Barcelona, Spain
Hospital La Fe de Valencia ( Site 0105), Valencia, Valenciana, Comunitat, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Medical Oncology ( Site 0106), Sevilla, , Spain
Chi Mei Medical Center ( Site 0215), Tainan City, Tainan, Taiwan
Kaohsiung Chang Gung Memorial Hospital ( Site 0209), Kaohsiung, , Taiwan
Taichung Veterans General Hospital ( Site 0213), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 0208), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0210), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0211), Taipei, , Taiwan
Chang Gung Medical Foundation.Linkou Branch ( Site 0212), Taoyuan, , Taiwan
University of Health Sciences,Gulhane School of Medicine-Oncology ( Site 0509), Ankara, , Turkey
Ankara Universitesi Tip Fakultesi. ( Site 0502), Ankara, , Turkey
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 0501), Istanbul, , Turkey
T.C. Saglik Bakanligi Turkiye Kamu Hastaneleri Kurumu - Baki-Istanbul Bakirkoy Sadi Konuk Training (, Istanbul, , Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0504), Istanbul, , Turkey
Ege University Medical Faculty ( Site 0508), Izmir, , Turkey
Karadeniz Teknik Universitesi Tip Fakultesi ( Site 0503), Trabzon, , Turkey
Clinical oncology dispensary of Dnipro ( Site 0133), Dnipro, Dnipropetrovska Oblast, Ukraine
Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0139), Kharkiv, Kharkivska Oblast, Ukraine
MNPE Regional Center of Oncology ( Site 0134), Kharkiv, Kharkivska Oblast, Ukraine
Ukranian Center of TomoTherapy ( Site 0140), Kropyvnytskiy, Kirovohradska Oblast, Ukraine
SNPE National Cancer Institute ( Site 0136), Kyiv, Kyivska Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 0135), Kyiv, , Ukraine
Betsi Cadwaladr University Health Board ( Site 0447), Rhyl, Denbighshire, United Kingdom
South Devon Healthcare Foundation Trust. Torbay Hospital ( Site 0444), Torquay, Devon, United Kingdom
Royal Preston Hospital ( Site 0449), Preston, Lancashire, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 0445), London, London, City Of, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 0442), London, London, City Of, United Kingdom
Nottingham University Hospital NHS Trust ( Site 0250), Nottingham, Nottinghamshire, United Kingdom
Darlington Memorial Hospital NHS Trust ( Site 0446), Darlington, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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