Spots Global Cancer Trial Database for Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
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Trial Identification
Brief Title: Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
Official Title: A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
Study ID: NCT03834519
Conditions
Study Description
Brief Summary: The purpose of this study is to assess the efficacy and safety of the combination of the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
St. Joseph Heritage Healthcare ( Site 0069), Fullerton, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0081), Los Angeles, California, United States
Sibley Memorial Hospital ( Site 0096), Washington, District of Columbia, United States
Georgia Cancer Center at Augusta University ( Site 0026), Augusta, Georgia, United States
Quincy Medical Group ( Site 0021), Quincy, Illinois, United States
Tulane Cancer Center ( Site 0066), New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005), Baltimore, Maryland, United States
Chesapeake Urology Research Associates ( Site 0076), Towson, Maryland, United States
Beth Israel Deaconess Medical Ctr. ( Site 0093), Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 0033), Boston, Massachusetts, United States
UMass Memorial Medical Center ( Site 0053), Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute ( Site 0077), Detroit, Michigan, United States
Henry Ford Health System ( Site 0039), Detroit, Michigan, United States
St. Vincent Frontier Cancer Center ( Site 0016), Billings, Montana, United States
Nebraska Cancer Specialists ( Site 0034), Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada ( Site 0092), Las Vegas, Nevada, United States
University of New Mexico Cancer Center ( Site 0048), Albuquerque, New Mexico, United States
Memorial Medical Center ( Site 0095), Las Cruces, New Mexico, United States
Associated Medical Professionals of NY ( Site 0060), Syracuse, New York, United States
Duke Cancer Center Cary ( Site 0010), Cary, North Carolina, United States
Gabrail Cancer Center-Research ( Site 0097), Canton, Ohio, United States
The Urology Group- Cincinnati ( Site 0094), Cincinnati, Ohio, United States
University Hospitals of Cleveland Seidman Cancer Center ( Site 0036), Cleveland, Ohio, United States
Carolina Urologic Research Center ( Site 0070), Myrtle Beach, South Carolina, United States
Huntsman Cancer Institute ( Site 0002), Salt Lake City, Utah, United States
Virginia Cancer Institute ( Site 0052), Richmond, Virginia, United States
Blue Ridge Cancer Care ( Site 0086), Roanoke, Virginia, United States
Seattle Cancer Care Alliance ( Site 0079), Seattle, Washington, United States
Froedtert and Medical College of Wisconsin ( Site 0045), Milwaukee, Wisconsin, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013), Berazategui, Buenos Aires, Argentina
Centro de Diagnostico Urologico ( Site 1008), Buenos Aires, Caba, Argentina
Hospital Britanico de Buenos Aires ( Site 1006), Buenos Aires, Caba, Argentina
Sanatorio Parque ( Site 1002), Rosario, Santa Fe, Argentina
Instituto de Investigaciones Metabolicas ( Site 1011), Buenos Aires, , Argentina
Hospital Aleman ( Site 1004), Buenos Aires, , Argentina
Instituto Medico Alexander Fleming ( Site 1010), Buenos Aires, , Argentina
CEMAIC ( Site 1014), Cordoba, , Argentina
St. Vincent's Hospital ( Site 0158), Darlinghurst, New South Wales, Australia
Macquarie University ( Site 0151), Macquarie University, New South Wales, Australia
Port Macquarie Base Hospital ( Site 0153), Port Macquarie, New South Wales, Australia
Calvary Mater Newcastle ( Site 0148), Waratah, New South Wales, Australia
Southern Medical Day Care Centre ( Site 0160), Wollongong, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 0155), Herston, Queensland, Australia
John Flynn Hospital & Medical Centre ( Site 0164), Tugun, Queensland, Australia
Box Hill Hospital ( Site 0146), Box Hill, Victoria, Australia
Peter MacCallum Cancer Centre ( Site 0152), Melbourne, Victoria, Australia
Fiona Stanley Hospital ( Site 0162), Murdoch, Western Australia, Australia
Ordensklinikum Linz GmbH Elisabethinen ( Site 0373), Linz, Oberosterreich, Austria
Medizinische Universitat Graz ( Site 0374), Graz, Steiermark, Austria
SCRI-CCCIT GesmbH ( Site 0371), Salzburg, , Austria
Medizinische Universitaet Wien ( Site 0375), Wien, , Austria
Hospital de Caridade de Ijui ( Site 1038), Ijui, Rio Grande Do Sul, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021), Porto Alegre, Rio Grande Do Sul, Brazil
Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035), Itajai, Santa Catarina, Brazil
Hospital de Base de Sao Jose de Rio Preto ( Site 1022), Sao Jose do Rio Preto, Sao Paulo, Brazil
IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040), São Paulo, Sao Paulo, Brazil
A.C. Camargo Cancer Center ( Site 1026), Sao Paulo, , Brazil
Cross Cancer Institute ( Site 0110), Edmonton, Alberta, Canada
BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113), Kelowna, British Columbia, Canada
BC Cancer-Vancouver Center ( Site 0112), Vancouver, British Columbia, Canada
Nova Scotia Health Authority QEII-HSC ( Site 0114), Halifax, Nova Scotia, Canada
William Osler Health System (Brampton Civic Hospital) ( Site 0121), Brampton, Ontario, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116), Hamilton, Ontario, Canada
Princess Margaret Cancer Centre ( Site 0107), Toronto, Ontario, Canada
CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102), Rimouski, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105), Sherbrooke, Quebec, Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0103), Quebec, , Canada
Centro Investigación del Cáncer James Lind ( Site 1041), Temuco, Araucania, Chile
Rey y Oreilly Limitada ( Site 1048), Temuco, Araucania, Chile
Fundacion Arturo Lopez Perez ( Site 1049), Santiago, Region M. De Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 1047), Santiago, Region M. De Santiago, Chile
Bradford Hill Centro de Investigaciones Clinicas ( Site 1044), Santiago, Region M. De Santiago, Chile
C.H. de Saint Quentin ( Site 0481), Saint Quentin, Aisne, France
Clinique Sainte Anne ( Site 0431), Strasbourg, Alsace, France
Centre Jean Perrin ( Site 0434), Clermont-Ferrand, Auvergne, France
Institut Paoli Calmettes ( Site 0419), Marseille, Bouches-du-Rhone, France
CHU de Brest -Site Hopital Morvan ( Site 0441), Brest, Bretagne, France
CHU Jean Minjoz ( Site 0423), Besancon, Doubs, France
Institut Bergonie ( Site 0421), Bordeaux, Gironde, France
Institut Claudius Regaud IUCT Oncopole ( Site 0418), Toulouse, Haute-Garonne, France
Hopital Foch ( Site 0428), Suresnes, Hauts-de-Seine, France
Institut Regional du Cancer de Montpellier - ICM ( Site 0443), Montpellier, Herault, France
Institut De Cancerologie De L Ouest ( Site 0448), Saint Herblain, Loire-Atlantique, France
Centre Hospitalier Regional du Orleans ( Site 0430), Orleans, Loiret, France
Centre D Oncologie de Gentilly ( Site 0432), Nancy, Meurthe-et-Moselle, France
Centre Leon Berard ( Site 0422), Lyon, Rhone, France
C.H.U. Lyon Sud ( Site 0436), Pierre Benite, Rhone, France
CHU Amiens Picardie Site Sud Amiens ( Site 0438), Amiens, Somme, France
Institut Gustave Roussy ( Site 0416), Villejuif, Val-de-Marne, France
Institut Sainte Catherine ( Site 0447), Avignon, Vaucluse, France
Institut Mutualiste Montsouris ( Site 0446), Paris, , France
Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304), Freiburg, Baden-Wurttemberg, Germany
Universitaetsklinikum in Mannheim ( Site 0314), Mannheim, Baden-Wurttemberg, Germany
Studienpraxis Urologie ( Site 0309), Nuertingen, Baden-Wurttemberg, Germany
Universitaetsklinik fuer Urologie ( Site 0307), Tuebingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Erlangen ( Site 0303), Erlangen, Bayern, Germany
Klinikum Rechts der Isar ( Site 0300), Muenchen, Bayern, Germany
Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318), Nuernberg, Bayern, Germany
Universitaetsklinikum Duesseldorf ( Site 0306), Duesseldorf, Nordrhein-Westfalen, Germany
Krankenhaus der Barmherzigen Brueder Trier ( Site 0310), Trier, Rheinland-Pfalz, Germany
Universitaetsklinikum Jena ( Site 0305), Jena, Thuringen, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301), Berlin, , Germany
Tallaght University Hospital ( Site 0730), Dublin, , Ireland
Mid Western Cancer Centre ( Site 0728), Limerick, , Ireland
Ha Emek Medical Center ( Site 0548), Afula, , Israel
Assaf Harofe ( Site 0547), Be'er- Ya'akov, , Israel
Soroka Medical Center ( Site 0549), Beer Sheva, , Israel
Rambam Medical Center ( Site 0543), Haifa, , Israel
Hadassah Ein Kerem Medical Center ( Site 0546), Jerusalem, , Israel
Meir Medical Center ( Site 0544), Kfar Saba, , Israel
Rabin Medical Center ( Site 0545), Petach-Tikwa, , Israel
Chaim Sheba Medical Center ( Site 0541), Ramat Gan, , Israel
Sourasky Medical Center ( Site 0542), Tel-Aviv, , Israel
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462), Meldola, Emilia-Romagna, Italy
Istituto Clinico Humanitas Research Hospital ( Site 0452), Rozzano, Lombardia, Italy
Medical Oncology Ospedale San Donato ( Site 0461), Arezzo, , Italy
Policlinico S.Orsola-Malpighi ( Site 0453), Bologna, , Italy
Azienda Ospedaliera Cannizzaro ( Site 0458), Catania, , Italy
Azienda Ospedaliera San Camillo Forlanini ( Site 0455), Roma, , Italy
Fondazione Policlinico Universitario A. Gemelli ( Site 0463), Roma, , Italy
Azienda Ospedaliera Santa Maria Terni ( Site 0456), Terni, , Italy
Presidio Ospedaliero Santa Chiara ( Site 0451), Trento, , Italy
Fujita Health University Hospital ( Site 0724), Toyoake, Aichi, Japan
National Cancer Center Hospital East ( Site 0702), Kashiwa, Chiba, Japan
Toho University Sakura Medical Center ( Site 0703), Sakura, Chiba, Japan
National Hospital Organization Shikoku Cancer Center ( Site 0716), Matsuyama, Ehime, Japan
Kobe City Medical Center General Hospital ( Site 0726), Kobe, Hyogo, Japan
Kanazawa University Hospital ( Site 0701), Kanazawa, Ishikawa, Japan
Kitasato University Hospital ( Site 0705), Sagamihara, Kanagawa, Japan
Yokohama City University Medical Center ( Site 0706), Yokohama, Kanagawa, Japan
Nara Medical University Hospital ( Site 0715), Kashihara, Nara, Japan
Kindai University Hospital ( Site 0714), Osakasayama, Osaka, Japan
Osaka University Hospital ( Site 0713), Suita, Osaka, Japan
Saitama Medical University International Medical Center ( Site 0708), Hidaka, Saitama, Japan
Dokkyo Medical University Saitama Medical Center ( Site 0707), Koshigaya, Saitama, Japan
Fuji City General Hospital ( Site 0725), Fuji, Shizuoka, Japan
Hamamatsu University Hospital ( Site 0720), Hamamatsu, Shizuoka, Japan
Yamaguchi University Hospital ( Site 0717), Ube, Yamaguchi, Japan
Chiba Cancer Center ( Site 0704), Chiba, , Japan
Kyushu University Hospital ( Site 0718), Fukuoka, , Japan
University of Miyazaki Hospital ( Site 0721), Miyazaki, , Japan
Nagano Municipal Hospital ( Site 0723), Nagano, , Japan
Nagasaki University Hospital ( Site 0719), Nagasaki, , Japan
Osaka International Cancer Institute ( Site 0722), Osaka, , Japan
Toranomon Hospital ( Site 0711), Tokyo, , Japan
Nippon Medical School Hospital ( Site 0709), Tokyo, , Japan
Keio University Hospital ( Site 0710), Tokyo, , Japan
Chonnam National University Hwasun Hospital ( Site 0174), Hwasun Gun, Jeonranamdo, Korea, Republic of
National Cancer Center ( Site 0176), Goyang-si, Kyonggi-do, Korea, Republic of
Asan Medical Center ( Site 0171), Songpagu, Seoul, Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 0173), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 0172), Seoul, , Korea, Republic of
Medisch Centrum Leeuwarden ( Site 0477), Leeuwarden, Fryslan, Netherlands
Radboud University Medical Center ( Site 0470), Nijmegen, Gelderland, Netherlands
Antoni van Leeuwenhoek Ziekenhuis ( Site 0480), Amsterdam, Noord-Holland, Netherlands
Vrije Universiteit Medisch Centrum ( Site 0479), Amsterdam, Noord-Holland, Netherlands
Spaarne Ziekenhuis ( Site 0473), Hoofddorp, Noord-Holland, Netherlands
Ziekenhuisgroep Twente ( Site 0469), Hengelo, Overijssel, Netherlands
Haaglanden MC - locatie Antoniushove ( Site 0471), Leidschendam, Zuid-Holland, Netherlands
Erasmus MC ( Site 0475), Rotterdam, Zuid-Holland, Netherlands
Franciscus Gasthuis en Vlietland ( Site 0489), Schiedam, Zuid-Holland, Netherlands
Auckland City Hospital ( Site 0193), Auckland, , New Zealand
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565), Chelyabinsk, Chelyabinskaya Oblast, Russian Federation
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585), Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
Russian Scientific Center of Roentgenoradiology ( Site 0559), Moscow, Moskva, Russian Federation
Central Clinical Hospital with Polyclinic ( Site 0562), Moscow, Moskva, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 0568), Omsk, Omskaya Oblast, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576), Samara, Samarskaya Oblast, Russian Federation
SBHI Leningrad Regional Oncology Dispensary ( Site 0588), Saint Petersburg, Sankt-Peterburg, Russian Federation
Clinical Research Center of specialized types medical care-Oncology ( Site 0570), Saint Petersburg, Sankt-Peterburg, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567), Saint Petersburg, Sankt-Peterburg, Russian Federation
Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579), Tomsk, Tomskaya Oblast, Russian Federation
Instituto Catalan de Oncologia - ICO ( Site 0330), L Hospitalet De Llobregat, Barcelona, Spain
Hospital Parc Tauli ( Site 0335), Sabadell, Barcelona, Spain
Hospital San Pedro de Alcantara ( Site 0326), Caceres, Extremadura, Spain
Hospital Josep Trueta ( Site 0321), Girona, Gerona, Spain
Hospital Quiron Madrid ( Site 0325), Pozuelo de Alarcon, Madrid, Spain
Hospital del Mar ( Site 0333), Barcelona, , Spain
Hospital General Universitari Vall d Hebron ( Site 0334), Barcelona, , Spain
Hospital Clinic ( Site 0323), Barcelona, , Spain
Hospital Universitario Virgen de la Victoria ( Site 0337), Malaga, , Spain
National Cheng Kung University Hospital ( Site 0134), Tainen, Tainan, Taiwan
China Medical University Hospital ( Site 0132), Taichung, , Taiwan
Taichung Veterans General Hospital ( Site 0133), Taichung, , Taiwan
National Taiwan University Hospital ( Site 0131), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 0135), Taipei, , Taiwan
University Hospitals Bristol NHS Foundation Trust ( Site 0530), Bristol, Bristol, City Of, United Kingdom
Cambridge University Hospitals NHS Trust ( Site 0540), Cambridge, Cambridgeshire, United Kingdom
Torbay Hospital ( Site 0532), Torquay, Devon, United Kingdom
Royal Marsden Hospital ( Site 0526), Sutton, England, United Kingdom
Musgrove Park Hospital ( Site 0537), Taunton, England, United Kingdom
University of North Midlands NHS Foundation Trust ( Site 0527), Stoke-on-Trent, Staffordshire, United Kingdom
Mount Vernon Cancer Centre ( Site 0536), Northwood, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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