Prostate Cancer Clinical Trial
Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641)
Summary
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and enzalutamide in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC, are abiraterone-naïve, or are intolerant to or progressed on abiraterone acetate. There are two primary study hypotheses.
Hypothesis 1: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus enzalutamide is superior to placebo plus enzalutamide with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.
Eligibility Criteria
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression)
Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
Participants must agree to the following during the study treatment period and for at least 90 days after the last dose of enzalutamide: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom
Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Exclusion Criteria:
Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
Has an active autoimmune disease that has required systemic treatment in past 2 years
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
Has an active infection (including tuberculosis) requiring systemic therapy
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
Has known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
Has a history of seizure or any condition that may predispose to seizure
Has a history of loss of consciousness within 12 months of screening
Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
Has bradycardia (heart rate of <50 beats per minute) on the screening electrocardiogram (ECG)
Has history of prostate cancer progression on ketoconazole
Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate
Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization
Has received a live or live attenuated vaccine within 30 days prior to randomization
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
Has a "superscan" bone scan
Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of enzalutamide
Has had an allogenic tissue/solid organ transplant
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There are 254 Locations for this study
Mobile Alabama, 36604, United States
Fullerton California, 92835, United States
Los Angeles California, 90404, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06513, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60608, United States
Merrillville Indiana, 46410, United States
New Orleans Louisiana, 70112, United States
Worcester Massachusetts, 01655, United States
Grand Rapids Michigan, 49503, United States
Traverse City Michigan, 49684, United States
Billings Montana, 59102, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89169, United States
Hackensack New Jersey, 07601, United States
Syracuse New York, 13210, United States
Salisbury North Carolina, 28144, United States
Canton Ohio, 44718, United States
Cincinnati Ohio, 45212, United States
Cleveland Ohio, 44106, United States
Portland Oregon, 97239, United States
Myrtle Beach South Carolina, 29572, United States
Fairfax Virginia, 22031, United States
Richmond Virginia, 23230, United States
Roanoke Virginia, 24014, United States
Milwaukee Wisconsin, 53226, United States
Berazategui Buenos Aires, B1884, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
Buenos Aires Caba, C1120, Argentina
Buenos Aires Caba, , Argentina
Rosario Santa Fe, S2000, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , C1012, Argentina
Buenos Aires , C1118, Argentina
Buenos Aires , C1426, Argentina
Cordoba , X5008, Argentina
La Rioja , F5300, Argentina
Mendoza , M5500, Argentina
Darlinghurst New South Wales, 2010, Australia
Kogarah New South Wales, 2217, Australia
Macquarie University New South Wales, 2109, Australia
Port Macquarie New South Wales, 2444, Australia
Waratah New South Wales, 2298, Australia
Greenslopes Queensland, 4120, Australia
Southport Queensland, 4215, Australia
Adelaide South Australia, 5000, Australia
Clayton Victoria, 3168, Australia
Perth Western Australia, 6150, Australia
Linz Oberosterreich, 4020, Austria
Wien , 1090, Austria
Curitiba Parana, 81520, Brazil
Natal Rio Grande Do Norte, 59075, Brazil
Ijui Rio Grande Do Sul, 98700, Brazil
Porto Alegre Rio Grande Do Sul, 90610, Brazil
Itajai Santa Catarina, 88301, Brazil
Sao Jose do Rio Preto Sao Paulo, 15090, Brazil
São Paulo Sao Paulo, 04014, Brazil
Sao Paulo , 01509, Brazil
Sofia Sofia (stolitsa), 1301, Bulgaria
Plovdiv , 4000, Bulgaria
Plovdiv , 4004, Bulgaria
Victoria British Columbia, V8R 6, Canada
Hamilton Ontario, L8V5C, Canada
Kitchener Ontario, N2G 1, Canada
Oshawa Ontario, L1G 2, Canada
Sudbury Ontario, P3E 5, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H2X 0, Canada
Rimouski Quebec, G5L 5, Canada
Sherbrooke Quebec, J1H 5, Canada
Quebec , G1R 2, Canada
Temuco Araucania, 47800, Chile
Temuco Araucania, 48101, Chile
Santiago Region M. De Santiago, 75009, Chile
Santiago Region M. De Santiago, 83300, Chile
Santiago Region M. De Santiago, 84203, Chile
Vina del Mar Valparaiso, 25205, Chile
Medellin Antioquia, 05003, Colombia
Barranquilla Atlantico, 08000, Colombia
Barranquilla Atlantico, 08002, Colombia
Valledupar Cesar, 20000, Colombia
Monteria Cordoba, 23000, Colombia
Bogota Distrito Capital De Bogota, 11132, Colombia
Cali Valle Del Cauca, 76004, Colombia
Cali Valle Del Cauca, 76004, Colombia
Brno Brno-mesto, 656 9, Czechia
Nový Jičín Novy Jicin, 741 0, Czechia
Olomouc , 779 0, Czechia
Saint Quentin Aisne, 02321, France
Strasbourg Alsace, 67000, France
Clermont-Ferrand Auvergne, 63011, France
Brest Bretagne, 29200, France
Besancon Doubs, 25000, France
Bordeaux Gironde, 33076, France
Toulouse Haute-Garonne, 31059, France
Suresnes Hauts-de-Seine, 92150, France
Montpellier Herault, 34298, France
Saint Herblain Loire-Atlantique, 44805, France
Orleans Loiret, 45100, France
Nancy Meurthe-et-Moselle, 54100, France
Valenciennes Nord, 59300, France
Pierre Benite Rhone, 69310, France
Amiens Somme, 80000, France
Villejuif Val-de-Marne, 94800, France
Avignon Vaucluse, 84000, France
Paris , 75014, France
Freiburg Baden-Wurttemberg, 79106, Germany
Nuertingen Baden-Wurttemberg, 72622, Germany
Tuebingen Baden-Wurttemberg, 72076, Germany
Muenchen Bayern, 81675, Germany
Nuernberg Bayern, 90419, Germany
Goettingen Niedersachsen, 37075, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Muenster Nordrhein-Westfalen, 48149, Germany
Trier Rheinland-Pfalz, 54292, Germany
Homburg Saarland, 66421, Germany
Luebeck Schleswig-Holstein, 23538, Germany
Jena Thuringen, 07747, Germany
Berlin , 10117, Germany
Kecskemét Bacs-Kiskun, 6000, Hungary
Gyor Gyor-Moson-Sopron, 9024, Hungary
Budapest Pest, 1122, Hungary
Budapest , 1062, Hungary
Dublin , D09 V, Ireland
Dublin , D24 N, Ireland
Limerick , V94 Y, Ireland
Afula , 18341, Israel
Ashdod , 77476, Israel
Beer Sheva , 84101, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petach-Tikwa , 49414, Israel
Ramat Gan , 52620, Israel
Tel Aviv , 64239, Israel
Zerifin , 70300, Israel
Meldola Emilia-Romagna, 47014, Italy
Rozzano Lombardia, 20089, Italy
Pozzuoli Napoli, 80078, Italy
Aviano Pordenone, 33081, Italy
Verona Veneto, 37134, Italy
Arezzo , 52100, Italy
Bologna , 40138, Italy
Catania , 95126, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Roma , 00152, Italy
Roma , 00168, Italy
Terni , 05100, Italy
Udine , 33100, Italy
Kashiwa Chiba, 277-8, Japan
Sakura Chiba, 285-8, Japan
Matsuyama Ehime, 791-0, Japan
Iizuka Fukuoka, 820-8, Japan
Hakodate Hokkaido, 040-8, Japan
Kanazawa Ishikawa, 920-8, Japan
Sagamihara Kanagawa, 252-0, Japan
Yokohama Kanagawa, 232-0, Japan
Natori Miyagi, 981-1, Japan
Kashihara Nara, 634-8, Japan
Osakasayama Osaka, 589-8, Japan
Suita Osaka, 565-0, Japan
Hidaka Saitama, 350-1, Japan
Kawagoe Saitama, 350-8, Japan
Koshigaya Saitama, 343-8, Japan
Hamamatsu Shizuoka, 431-3, Japan
Ube Yamaguchi, 755-8, Japan
Chiba , 260-8, Japan
Fukuoka , 812-8, Japan
Hiroshima , 734-8, Japan
Miyazaki , 889-1, Japan
Nagasaki , 852-8, Japan
Tokyo , 105-8, Japan
Tokyo , 113-8, Japan
Tokyo , 160-8, Japan
Goyang-si Kyonggi-do, 10408, Korea, Republic of
Seongnam-si Kyonggi-do, 13620, Korea, Republic of
Songpagu Seoul, 05505, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 06351, Korea, Republic of
Nijmegen Gelderland, 6525 , Netherlands
Maastricht Limburg, 6202A, Netherlands
Breda Noord-Brabant, 4818 , Netherlands
Eindhoven Noord-Brabant, 5623 , Netherlands
Alkmaar Noord-Holland, 1815 , Netherlands
Amsterdam Noord-Holland, 1081 , Netherlands
Hilversum Noord-Holland, 1213 , Netherlands
Hoofddorp Noord-Holland, 2134T, Netherlands
Hengelo Overijssel, 7555 , Netherlands
Leidschendam Zuid-Holland, 2262 , Netherlands
Schiedam Zuid-Holland, 3118 , Netherlands
Tauranga Bay Of Plenty, 3112, New Zealand
Christchurch Canterbury, 8011, New Zealand
Auckland , 1023, New Zealand
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Lodz Lodzkie, 91-21, Poland
Tomaszow Mazowiecki Lodzkie, 97-20, Poland
Warszawa Mazowieckie, 02-79, Poland
Konin Wielkopolskie, 62-50, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
San Juan , 00918, Puerto Rico
San Juan , 00927, Puerto Rico
Chelyabinsk Chelyabinskaya Oblast, 45408, Russian Federation
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Moscow Moskva, 11748, Russian Federation
Moscow Moskva, 12135, Russian Federation
Omsk Omskaya Oblast, 64401, Russian Federation
Samara Samarskaya Oblast, 44303, Russian Federation
Saint Petersburg Sankt-Peterburg, 19110, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Tomsk Tomskaya Oblast, 63405, Russian Federation
L Hospitalet De Llobregat Barcelona, 08908, Spain
Sabadell Barcelona, 08208, Spain
Girona Gerona, 17007, Spain
Pozuelo de Alarcon Madrid, 28223, Spain
Valencia Valenciana, Comunitat, 46009, Spain
Barcelona , 08003, Spain
Caceres , 10003, Spain
Madrid , 28007, Spain
Madrid , 28033, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Malaga , 29016, Spain
Sevilla , 41013, Spain
Tainen Tainan, 704, Taiwan
Taichung , 40447, Taiwan
Taichung , 407, Taiwan
Taipei , 10048, Taiwan
Taipei , 112, Taiwan
Bornova Izmir, 35100, Turkey
Adana , 01250, Turkey
Ankara , 06100, Turkey
Ankara , 06230, Turkey
Ankara , 06800, Turkey
Istanbul , 34440, Turkey
İstanbul , 34457, Turkey
Istanbul , 34722, Turkey
Cherkassy Cherkaska Oblast, 18009, Ukraine
Dnipropetrovsk Dnipropetrovska Oblast, 49055, Ukraine
Dnipro Dnipropetrovska Oblast, 49005, Ukraine
Ivano-Frankivsk Ivano-Frankivska Oblast, 76008, Ukraine
Ivano-Frankivsk Ivano-Frankivska Oblast, 76018, Ukraine
Kharkiv Kharkivska Oblast, 61070, Ukraine
Kiev Kyivska Oblast, 08720, Ukraine
Kyiv Kyivska Oblast, 03115, Ukraine
Bristol Bristol, City Of, BS2 8, United Kingdom
Cambridge Cambridgeshire, CB2 0, United Kingdom
Torquay Devon, TQ2 7, United Kingdom
London London, City Of, NW1 2, United Kingdom
Taunton Somerset, TA1 5, United Kingdom
London Sutton, SM2 5, United Kingdom
Edinburgh Worcestershire, EH42X, United Kingdom
Northwood , HA6 2, United Kingdom
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