Prostate Cancer Clinical Trial
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
Summary
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA).
There are two primary study hypotheses.
Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS).
Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone 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.
Full Description
With Amendment 6 (effective date: 29-Sep-2022), all participants will be unblinded and placebo treatment will be stopping. Participants who are deemed to be deriving clinical benefit from treatment may continue at the discretion of the investigator.
The global study for MK-3475-921 enrolled 1030 participants. Of the 1030 total participants enrolled in the global study, 21 were also enrolled in the China extension study for MK-3475-921 (NCT04907227).
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 screening
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 received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
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 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
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 (non-infectious) pneumonitis that required steroids or current pneumonitis
Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients
Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to mAbs
Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
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 co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
Has hypersensitivity to docetaxel or polysorbate 80
Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade ≤1 or at baseline) from AEs due to a previously administered agent
Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
Has received a live vaccine within 30 days prior to randomization
Has received treatment with 5α reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization
Has received prior treatment with ketoconazole for prostate cancer
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 120 days after the last dose of study treatment
Has had an allogenic tissue/solid organ transplant
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 210 Locations for this study
Mobile Alabama, 36604, United States
Fullerton California, 92835, United States
Los Angeles California, 90033, United States
Newport Beach California, 92663, United States
San Francisco California, 94158, United States
Aurora Colorado, 80045, United States
New Haven Connecticut, 06510, United States
Tampa Florida, 33612, United States
Augusta Georgia, 30912, United States
Chicago Illinois, 60608, United States
Merrillville Indiana, 46410, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Saint Louis Missouri, 63110, 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
Durham North Carolina, 27710, United States
Salisbury North Carolina, 28144, 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
Berazategui Buenos Aires, B1884, Argentina
Mar del Plata Buenos Aires, B7600, Argentina
Buenos Aires Caba, C1120, Argentina
Buenos Aires Caba, C1280, Argentina
Rosario Santa Fe, S2000, Argentina
Buenos Aires , C1012, Argentina
Buenos Aires , C1118, Argentina
Buenos Aires , C1426, Argentina
Cordoba , X5008, Argentina
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
Redcliffe Queensland, 4020, Australia
Tugun Queensland, 4224, Australia
Nedlands Western Australia, 6009, Australia
Linz Oberosterreich, 4020, Austria
Graz Steiermark, 8036, Austria
Salzburg , 5020, Austria
Wien , 1090, Austria
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
Sao Paulo , 01509, Brazil
Halifax Nova Scotia, B3H 2, Canada
Hamilton Ontario, L8V5C, Canada
Kitchener Ontario, N2G 1, Canada
Oshawa Ontario, L1G 2, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, 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, 25404, Chile
Beijing Beijing, 10003, China
Beijing Beijing, 10007, China
Beijing Beijing, 10014, China
Xiamen Fujian, 36100, China
Guangzhou Guangdong, 51022, China
Guangzhou Guangdong, 51023, China
Harbin Heilongjiang, 15008, China
Zhengzhou Henan, 45000, China
Wuhan Hubei, 43007, China
Changsha Hunan, 41001, China
Nanjing Jiangsu, 21000, China
Shanghai Shanghai, 20003, China
Shanghai Shanghai, 20003, China
Hangzhou Zhejiang, 31000, China
Hangzhou Zhejiang, 31001, China
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, 11032, Colombia
Bogota Distrito Capital De Bogota, 11132, Colombia
Pereira Risaralda, 66000, Colombia
Cali Valle Del Cauca, 76004, Colombia
Cali Valle Del Cauca, 76004, Colombia
Saint Quentin Aisne, 02321, France
Strasbourg Alsace, 67000, France
Clermont-Ferrand Auvergne, 63011, France
Lyon Auvergne, 69373, France
Marseille Bouches-du-Rhone, 13009, France
Besancon Doubs, 25000, France
Brest Finistere, 29200, France
Bordeaux Gironde, 33076, France
Toulouse Haute-Garonne, 31059, France
Suresnes Hauts-de-Seine, 92151, France
Saint Herblain Loire-Atlantique, 44805, France
Orleans Loiret, 45100, France
Nancy Meurthe-et-Moselle, 54100, 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
Mannheim Baden-Wurttemberg, 68167, Germany
Nuertingen Baden-Wurttemberg, 72622, Germany
Tuebingen Baden-Wurttemberg, 72076, Germany
Muenchen Bayern, 81675, Germany
Nuernberg Bayern, 90419, Germany
Wuerzburg Bayern, 97080, Germany
Goettingen Niedersachsen, 37075, Germany
Aachen Nordrhein-Westfalen, 52074, Germany
Homburg Saarland, 66421, Germany
Jena Thuringen, 07747, Germany
Berlin , 10117, Germany
Cork , T12 Y, Ireland
Dublin , D24 N, Ireland
Limerick , , Ireland
Beer Sheva , 84101, Israel
Beer Yaakov-Zerifin , 70300, Israel
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar Saba , 44281, Israel
Petach-Tikwa , 49414, Israel
Ramat Gan , 52620, Israel
Tel Aviv , 64239, Israel
Rozzano Milano, 20089, Italy
Catania , 95126, Italy
Modena , 41100, Italy
Napoli , 80131, Italy
Roma , 00152, Italy
Terni , 05100, Italy
Trento , 38122, Italy
Kashiwa Chiba, 277-8, Japan
Sakura Chiba, 285-8, Japan
Matsuyama Ehime, 791-0, Japan
Kanazawa Ishikawa, 920-8, Japan
Sagamihara Kanagawa, 252-0, Japan
Yokohama Kanagawa, 232-0, Japan
Kashihara Nara, 634-8, Japan
Osakasayama Osaka, 589-8, Japan
Suita Osaka, 565-0, Japan
Hidaka Saitama, 1932, Japan
Koshigaya Saitama, 343-8, Japan
Hamamatsu Shizuoka, 431-3, Japan
Ube Yamaguchi, 755-8, Japan
Chiba , 260-8, Japan
Fukuoka , 812-8, 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
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06351, Korea, Republic of
Leeuwarden Fryslan, 8934 , Netherlands
Ede Gelderland, 6746 , Netherlands
Nijmegen Gelderland, 6525 , Netherlands
Venlo Limburg, 5912 , Netherlands
Den Bosch Noord-Brabant, 5223 , Netherlands
Eindhoven Noord-Brabant, 5623 , Netherlands
Amsterdam Noord-Holland, 1066 , Netherlands
Hilversum Noord-Holland, 1213 , Netherlands
Hengelo Overijssel, 7555 , Netherlands
Delft Zuid-Holland, 2625 , Netherlands
Den Haag Zuid-Holland, 2545 , Netherlands
Chelyabinsk Chelyabinskaya Oblast, 45408, Russian Federation
Krasnoyarsk Krasnoyarskiy Kray, 66013, Russian Federation
Moscow Moskva, 10507, Russian Federation
Moscow Moskva, 11748, Russian Federation
Moscow Moskva, 12135, Russian Federation
Moscow Moskva, 12528, Russian Federation
Nizhny Novgorod Nizhegorodskaya Oblast, 60307, Russian Federation
Omsk Omskaya Oblast, 64401, Russian Federation
Samara Samarskaya Oblast, 44303, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint Petersburg Sankt-Peterburg, 19825, Russian Federation
Saint-Petersburg Sankt-Peterburg, 18866, Russian Federation
Tomsk Tomskaya Oblast, 63405, Russian Federation
L Hospitalet De Llobregat Barcelona, 08908, Spain
Sabadell Barcelona, 08208, Spain
Santander Cantabria, 39008, Spain
Girona Gerona, 17007, Spain
Barcelona , 08003, Spain
Barcelona , 08036, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Malaga , 29016, Spain
Sevilla , 41013, Spain
Tainen Tainan, 704, Taiwan
Taichung , 40447, Taiwan
Taichung , 40705, Taiwan
Taipei , 10048, Taiwan
Taipei , 11217, Taiwan
Bristol Bristol, City Of, BS2 8, United Kingdom
Cambridge Cambridgeshire, CB2 0, United Kingdom
Torquay Devon, TQ2 7, United Kingdom
Sheffield England, S10 2, United Kingdom
Sutton England, SM2 5, United Kingdom
Northwood Hertfordshire, HA6 2, United Kingdom
London London, City Of, EC1A , United Kingdom
Stoke-on-Trent Staffordshire, ST4 6, United Kingdom
How clear is this clinincal trial information?