Spots Global Cancer Trial Database for Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)
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Trial Identification
Brief Title: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)
Official Title: A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)
Study ID: NCT04191096
Study Description
Brief Summary: This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Alaska Clinical Research Center ( Site 0274), Anchorage, Alaska, United States
Providence Alaska Medical Center ( Site 0276), Anchorage, Alaska, United States
City of Hope Medical Center ( Site 0217), Duarte, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0241), Los Angeles, California, United States
University of Colorado, Anschutz Cancer Pavilion ( Site 0236), Aurora, Colorado, United States
Hartford HealthCare Medical Group ( Site 0212), Manchester, Connecticut, United States
Smilow Cancer Center at Yale-New Haven ( Site 0250), New Haven, Connecticut, United States
Sibley Memorial Hospital ( Site 0275), Washington, District of Columbia, United States
Winship Cancer Institute of Emory University ( Site 0209), Atlanta, Georgia, United States
The University of Chicago ( Site 0264), Chicago, Illinois, United States
Springfield Clinic [Springfield, IL] ( Site 0240), Springfield, Illinois, United States
Cotton-O'Neil Cancer Center ( Site 0228), Topeka, Kansas, United States
The Sidney Kimmel Comprehensive Cancer Center ( Site 0204), Baltimore, Maryland, United States
St. Vincent Frontier Cancer Center-Research ( Site 0213), Billings, Montana, United States
Comprehensive Cancer Centers of Nevada ( Site 0269), Las Vegas, Nevada, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0270), New York, New York, United States
Weill Cornell Medical College ( Site 0263), New York, New York, United States
Associated Medical Professionals of NY ( Site 0251), Syracuse, New York, United States
Duke University ( Site 0206), Durham, North Carolina, United States
Tri-State Urologic Services PSC, Inc. ( Site 0253), Cincinnati, Ohio, United States
MidLantic Urology ( Site 0273), Bala-Cynwyd, Pennsylvania, United States
Ralph H. Johnson VA Center ( Site 0256), Charleston, South Carolina, United States
Carolina Urologic Research Center ( Site 0259), Myrtle Beach, South Carolina, United States
Urology Associates [Nashville, TN] ( Site 0233), Nashville, Tennessee, United States
Inova Health System ( Site 0205), Fairfax, Virginia, United States
Urology of Virginia ( Site 0224), Virginia Beach, Virginia, United States
Seattle Cancer Care Alliance ( Site 0258), Seattle, Washington, United States
Chris OBrien Lifehouse ( Site 0300), Camperdown, New South Wales, Australia
Port Macquarie Base Hospital ( Site 0301), Port Macquarie, New South Wales, Australia
Riverina Cancer Care Center ( Site 0302), Wagga Wagga, New South Wales, Australia
Gallipoli Medical Research Foundation ( Site 0309), Greenslopes, Queensland, Australia
John Flynn Hospital & Medical Centre ( Site 0308), Tugun, Queensland, Australia
Box Hill Hospital ( Site 0304), Box Hill, Victoria, Australia
Monash Health ( Site 0305), Clayton, Victoria, Australia
Peter MacCallum Cancer Centre ( Site 0306), Melbourne, Victoria, Australia
Fiona Stanley Hospital ( Site 0311), Murdoch, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen ( Site 0901), Linz, Oberosterreich, Austria
Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 0900), Salzburg, , Austria
Krankenhaus der Barmherzigen Brüder Wien ( Site 0904), Wien, , Austria
Medizinische Universitaet Wien ( Site 0903), Wien, , Austria
Oncocentro Ceara ( Site 2309), Fortaleza, Ceara, Brazil
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 2306), Curitiba, Parana, Brazil
Hospital Sao Vicente de Paulo ( Site 2303), Passo Fundo, Rio Grande Do Sul, Brazil
Hospital de Clinicas de Porto Alegre ( Site 2304), Porto Alegre, Rio Grande Do Sul, Brazil
Clinica de Oncologia Reichow ( Site 2308), Blumenau, Santa Catarina, Brazil
Fundacao Dr Amaral Carvalho ( Site 2302), Jau, Sao Paulo, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 2305), Sao Paulo, , Brazil
The Ottawa Hospital ( Site 0100), Ottawa, Ontario, Canada
Niagara Health System - St. Catharines ( Site 0107), St. Catharines, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0105), Greenfield Park, Quebec, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0109), Montreal, Quebec, Canada
CIUSSS Ouest de l Ile - St-Mary s Hospital ( Site 0106), Montreal, Quebec, Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0101), Quebec, , Canada
Centro Investigación del Cáncer James Lind ( Site 2401), Temuco, Araucania, Chile
IC La Serena Research ( Site 2406), La Serena, Coquimbo, Chile
Clinica Universidad Catolica del Maule ( Site 2407), Talca, Maule, Chile
Clinica Alemana ( Site 2408), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 2402), Santiago, Region M. De Santiago, Chile
Sociedad Medica Aren y Bachero Limitada ( Site 2403), Santiago, Region M. De Santiago, Chile
Oncocentro ( Site 2400), Vina del Mar, Valparaiso, Chile
Peking University First Hospital ( Site 0800), Beijing, Beijing, China
Zhejiang Provincial People's Hospital ( Site 0809), Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0834), Wenzhou, Zhejiang, China
Institucion Prestadora de Servicios de Salud Clinica de la Costa LTDA ( Site 2504), Barranquilla, Atlantico, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2509), Valledupar, Cesar, Colombia
Administradora Country SA - Clinica del Country ( Site 2507), Bogota, Distrito Capital De Bogota, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 2506), Bogota, Distrito Capital De Bogota, Colombia
Hemato Oncologos ( Site 2503), Cali, Valle Del Cauca, Colombia
Rigshospitalet ( Site 1005), Copenhagen, Hovedstaden, Denmark
Herlev og Gentofte Hospital. ( Site 1004), Herlev, Hovedstaden, Denmark
Aalborg Universitetshospital ( Site 1000), Aalborg, Nordjylland, Denmark
Odense Universitetshospital ( Site 1003), Odense, Syddanmark, Denmark
Vejle Sygehus ( Site 1002), Vejle, Syddanmark, Denmark
Keski-Suomen keskussairaala ( Site 1017), Jyvaskyla, Mellersta Finland, Finland
Tampereen yliopistollinen sairaala ( Site 1022), Tampere, Pirkanmaa, Finland
HYKS ( Site 1020), Helsinki, Varsinais-Suomi, Finland
TYKS T-sairaala Syopatautien pkl ( Site 1019), Turku, Varsinais-Suomi, Finland
Centre Leon-Berard ( Site 1110), Lyon, Auvergne, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1114), Strasbourg, Bas-Rhin, France
CHU de Brest -Site Hopital Morvan ( Site 1103), Brest, Bretagne, France
Centre Georges Francois Leclerc ( Site 1112), Dijon, Cote-d Or, France
CHU-Jean Minjoz ( Site 1101), Besancon, Doubs, France
Institut Bergonie ( Site 1104), Bordeaux, Gironde, France
Hopital Foch ( Site 1105), Suresnes, Hauts-de-Seine, France
C.H.R.U. de Rennes. Hopital de Pontchaillou ( Site 1117), Rennes, Ille-et-Vilaine, France
Institut Jean Godinot-Clinical Research Unit ( Site 1118), Reims, Marne, France
Centre D Oncologie de Gentilly ( Site 1107), Nancy, Meurthe-et-Moselle, France
Centre Bourgogne ( Site 1119), Lille, Nord-Pas-de-Calais, France
Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 1102), Pierre Benite, Rhone, France
Hopital Henri Mondor ( Site 1116), Creteil, Val-de-Marne, France
Universitaetsklinikum Freiburg ( Site 1200), Freiburg, Baden-Wurttemberg, Germany
Klinikum der Universitaet Muenchen - Grosshadern ( Site 1210), Muenchen, Bayern, Germany
Klinikum Rechts der Isar ( Site 1206), Munchen, Bayern, Germany
Klinikum Nuernberg Nord ( Site 1213), Nurnberg, Bayern, Germany
Staedtisches Klinikum Braunschweig gGmbH ( Site 1217), Braunschweig, Niedersachsen, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 1211), Magdeburg, Sachsen-Anhalt, Germany
Universitaetsklinikum der Technischen Universitaet Dresden ( Site 1204), Dresden, Sachsen, Germany
Charite Universitaetsmedizin Berlin ( Site 1201), Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 1212), Hamburg, , Germany
Cork University Hospital ( Site 1304), Cork, , Ireland
Beaumont Hospital ( Site 1302), Dublin, , Ireland
Tallaght University Hospital ( Site 1301), Dublin, , Ireland
St Vincents University Hospital ( Site 1300), Dublin, , Ireland
University Hospital Limerick ( Site 1305), Limerick, , Ireland
University Hospital Waterford ( Site 1303), Waterford, , Ireland
Rambam Medical Center ( Site 1400), Haifa, , Israel
Hadassah Ein Kerem Medical Center ( Site 1404), Jerusalem, , Israel
Meir Medical Center ( Site 1401), Kfar Saba, , Israel
Rabin Medical Center ( Site 1402), Petach Tikva, , Israel
Sourasky Medical Center ( Site 1403), Tel Aviv, , Israel
Assaf Harofeh Medical Center ( Site 1405), Zerifin, , Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1503), Meldola, Emilia-Romagna, Italy
Istituto Clinico Humanitas Research Hospital ( Site 1500), Rozzano, Lombardia, Italy
Centro Di Riferimento Oncologico ( Site 1511), Aviano, Pordenone, Italy
IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 1509), Bari, , Italy
Azienda Ospedaliera Cannizzaro ( Site 1501), Catania, , Italy
Istituto Nazionale dei Tumori ( Site 1510), Milano, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 1508), Napoli, , Italy
Fondazione Policlinico Universitario A. Gemelli ( Site 1512), Roma, , Italy
Azienda Ospedaliera Santa Maria ( Site 1502), Terni, , Italy
A.O. Verona-Ospedale Civile Maggiore Borgo-Trento ( Site 1504), Verona, , Italy
Toho University Sakura Medical Center ( Site 0732), Sakura, Chiba, Japan
Ehime University Hospital ( Site 0745), Toon, Ehime, Japan
Sapporo Medical University Hospital ( Site 0730), Sapporo, Hokkaido, Japan
Kitasato University Hospital ( Site 0734), Sagamihara, Kanagawa, Japan
Yokohama City University Medical Center ( Site 0735), Yokohama, Kanagawa, Japan
Nara Medical University Hospital ( Site 0744), Kashihara, Nara, Japan
Kindai University Hospital ( Site 0743), Osakasayama, Osaka, Japan
Osaka University Hospital ( Site 0742), Suita, Osaka, Japan
Saitama Medical University International Medical Center ( Site 0737), Hidaka, Saitama, Japan
Dokkyo Medical University Saitama Medical Center ( Site 0736), Koshigaya, Saitama, Japan
Hamamatsu University Hospital ( Site 0748), Hamamatsu, Shizuoka, Japan
Yamaguchi University Hospital ( Site 0746), Ube, Yamaguchi, Japan
Chiba Cancer Center ( Site 0733), Chiba, , Japan
Harasanshin Hospital ( Site 0747), Fukuoka, , Japan
Nagano Municipal Hospital ( Site 0731), Nagano, , Japan
Osaka City University Hospital ( Site 0741), Osaka, , Japan
Toranomon Hospital ( Site 0740), Tokyo, , Japan
Nippon Medical School Hospital ( Site 0738), Tokyo, , Japan
Tokyo Women's Medical University Hospital ( Site 0739), Tokyo, , Japan
Chonnam National University Hwasun Hospital ( Site 0406), Jeollanam-do, Jeonranamdo, Korea, Republic of
National Cancer Center ( Site 0400), Gyeonggi-do, Kyonggi-do, Korea, Republic of
Seoul National University Bundang Hospital ( Site 0401), Seongnam-si, Kyonggi-do, Korea, Republic of
Kyungpook National University Chilgok Hospital ( Site 0404), Daegu, Taegu-Kwangyokshi, Korea, Republic of
Seoul National University Hospital ( Site 0405), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0402), Seoul, , Korea, Republic of
Asan Medical Center ( Site 0403), Seoul, , Korea, Republic of
Hospital San Lucas Cardiologica del Sureste ( Site 2606), Tuxtla Gutierrez, Chiapas, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde ( Site 2607), Guadalajara, Jalisco, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 2608), Chihuahua, , Mexico
Grupo Medico Camino SC ( Site 2613), Mexico City, , Mexico
Centro Oncologico Internacional. SEDNA ( Site 2609), Mexico City, , Mexico
Boca Raton Clinical Research QTO ( Site 2611), Queretaro, , Mexico
Radboud University Medical Center ( Site 1606), Nijmegen, Gelderland, Netherlands
Antoni van Leeuwenhoek Ziekenhuis ( Site 1603), Amsterdam, Noord-Holland, Netherlands
Vrije Universiteit Medisch Centrum ( Site 1601), Amsterdam, Noord-Holland, Netherlands
Isala Klinieken, Locatie Sophia ( Site 1604), Zwolle, Overijssel, Netherlands
Meander Medisch Centrum ( Site 1602), Amersfoort, Utrecht, Netherlands
Franciscus Gasthuis en Vlietland ( Site 1605), Schiedam, Zuid-Holland, Netherlands
St. Antonius Ziekenhuis ( Site 1600), Utrecht, , Netherlands
Auckland City Hospital ( Site 0321), Auckland, , New Zealand
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 2700), Arequipa, Ariqipa, Peru
Clinica Peruano Americana S.A. ( Site 2702), Trujillo, La Libertad, Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 2708), Lima, , Peru
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 2706), Lima, , Peru
Hospital Militar Central [Lima, Peru] ( Site 2704), Lima, , Peru
Szpital Uniwersytecki nr 1 im. Dr. Antoniego Jurasza w Bydgoszczy ( Site 1720), Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1716), Bydgoszcz, Kujawsko-pomorskie, Poland
Nasz Lekarz Przychodnie Medyczne ( Site 1718), Torun, Kujawsko-pomorskie, Poland
Szpital Uniwersytecki w Krakowie ( Site 1707), Krakow, Malopolskie, Poland
Radomskie Centrum Onkologii ( Site 1701), Radom, Mazowieckie, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1700), Przemysl, Podkarpackie, Poland
Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1717), Bytom, Slaskie, Poland
Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu Medycznego im. K. Marcinkowskiego w Pozna, Poznan, Wielkopolskie, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1709), Koszalin, Zachodniopomorskie, Poland
Twoja Przychodnia - Szczeciskie Centrum Medyczne ( Site 1721), Szczecin, Zachodniopomorskie, Poland
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1810), Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
SBIH City clinical hospital named after D.D. Pletniov ( Site 1813), Moscow, Moskva, Russian Federation
Russian Scientific Center of Roentgenoradiology ( Site 1800), Moscow, Moskva, Russian Federation
Volga District Medical Center Federal Medical and Biological Agency ( Site 1805), Nizhny Novgorod, Nizhegorodskaya Oblast, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 1809), Omsk, Omskaya Oblast, Russian Federation
Instituto Catalan de Oncologia - ICO ( Site 1901), Hospitalet de Llobregat, Barcelona, Spain
Hospital Josep Trueta ( Site 1900), Girona, Gerona, Spain
Hospital Universitario Lucus Augusti ( Site 1905), Lugo, , Spain
Hospital Universitario Ramon y Cajal ( Site 1902), Madrid, , Spain
Hospital Clinico San Carlos ( Site 1906), Madrid, , Spain
Hospital 12 de Octubre de Madrid ( Site 1903), Madrid, , Spain
Hospital Virgen de la Macarena ( Site 1904), Sevilla, , Spain
Kantonsspital Graubuenden ( Site 2003), Chur, Grisons, Switzerland
Kantonsspital St. Gallen ( Site 2000), St. Gallen, Sankt Gallen, Switzerland
CHUV (centre hospitalier universitaire vaudois) ( Site 2002), Lausanne, Vaud, Switzerland
Universitaetsspital Zuerich ( Site 2001), Zuerich, Zurich, Switzerland
Kaohsiung Chang Gung Memorial Hospital ( Site 0504), Kaohsiung, , Taiwan
National Cheng Kung University Hospital ( Site 0503), Tainan, , Taiwan
National Taiwan University Hospital ( Site 0500), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0501), Taipei, , Taiwan
Chang Gung Medical Foundation. Linkou ( Site 0502), Taoyuan, , Taiwan
Chulalongkorn Hospital, Medical Oncology Unit ( Site 0600), Bangkok, Krung Thep Maha Nakhon, Thailand
Ramathibodi Hospital. ( Site 0601), Bangkok, Krung Thep Maha Nakhon, Thailand
Faculty of Medicine Siriraj Hospital ( Site 0602), Bangkok, Krung Thep Maha Nakhon, Thailand
Srinagarind Hospital ( Site 0604), Khon Kaen, , Thailand
Acibadem Adana Hastanesi ( Site 2106), Adana, , Turkey
Ankara Universitesi Tip Fakultesi. ( Site 2101), Ankara, , Turkey
Hacettepe Universitesi Tıp Fakultesi ( Site 2105), Ankara, , Turkey
Ankara Sehir Hastanesi ( Site 2103), Ankara, , Turkey
Istanbul Uni. Cerrahpasa Tip Fakultesi ( Site 2100), Istanbul, , Turkey
Ege University Medical Faculty Tulay Aktas Oncology Hospital ( Site 2102), Izmir, , Turkey
Konya Necmettin Erbakan University Medical Faculty ( Site 2104), Konya, , Turkey
Aberdeen Royal Infirmary ( Site 1315), Aberdeen, Aberdeen City, United Kingdom
Royal Cornwall Hospitals NHS Trust ( Site 1317), Truro, Cornwall, United Kingdom
University College London Hospitals NHS Foundation Trust ( Site 1320), London, London, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1318), London, London, City Of, United Kingdom
Velindre Cancer Centre Hospital ( Site 1322), Cardiff, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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