Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03834493




Registration number
NCT03834493
Ethics application status
Date submitted
6/02/2019
Date registered
8/02/2019
Date last updated
20/12/2023

Titles & IDs
Public title
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)
Scientific title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (KEYNOTE-641)
Secondary ID [1] 0 0
MK-3475-641
Secondary ID [2] 0 0
3475-641
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Placebo

Experimental: Pembrolizumab + Enzalutamide - Participants receive 200 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered orally (PO) once a day (QD) continuously until progression.

Placebo comparator: Placebo + Enzalutamide - Participants receive placebo by IV infusion administered on Day 1 Q3W for up to 35 cycles (approximately 2 years) PLUS enzalutamide 160 mg administered PO QD continuously until progression.


Treatment: Other: Pembrolizumab
IV infusion

Treatment: Drugs: Enzalutamide
Capsules/Tablets

Treatment: Drugs: Placebo
IV infusion
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [1] 0 0
Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)
Timepoint [1] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [2] 0 0
Prostate-specific Antigen (PSA) Response Rate
Timepoint [2] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [3] 0 0
Prostate-specific Antigen (PSA) Undetectable Rate
Timepoint [3] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [4] 0 0
Objective Response (OR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
Timepoint [4] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [5] 0 0
Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
Timepoint [5] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [6] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [6] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [7] 0 0
Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by as Assessed by Blinded Independent Central Review
Timepoint [7] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [8] 0 0
Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score)
Timepoint [8] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [9] 0 0
Time to First Symptomatic Skeletal-related Event (SSRE)
Timepoint [9] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [10] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [10] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Secondary outcome [11] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [11] 0 0
Up to 40 months (through database cut-off date of 12-Dec-2022)

Eligibility
Key inclusion criteria
The main inclusion and exclusion criteria include but are not limited to the following:



* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
Accrual to date
Final
1244
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital ( Site 0158) - Darlinghurst
Recruitment hospital [2] 0 0
St George Hospital ( Site 0157) - Kogarah
Recruitment hospital [3] 0 0
Macquarie University ( Site 0151) - Macquarie University
Recruitment hospital [4] 0 0
Port Macquarie Base Hospital ( Site 0153) - Port Macquarie
Recruitment hospital [5] 0 0
Calvary Mater Newcastle ( Site 0148) - Waratah
Recruitment hospital [6] 0 0
Gallipoli Medical Research Foundation ( Site 0149) - Greenslopes
Recruitment hospital [7] 0 0
Gold Coast University Hospital ( Site 0150) - Southport
Recruitment hospital [8] 0 0
Royal Adelaide Hospital ( Site 0154) - Adelaide
Recruitment hospital [9] 0 0
Monash Health-Monash Medical Centre ( Site 0147) - Clayton
Recruitment hospital [10] 0 0
Fiona Stanley Hospital ( Site 0162) - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2109 - Macquarie University
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
2298 - Waratah
Recruitment postcode(s) [6] 0 0
4120 - Greenslopes
Recruitment postcode(s) [7] 0 0
4215 - Southport
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3168 - Clayton
Recruitment postcode(s) [10] 0 0
6150 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Montana
Country [13] 0 0
United States of America
State/province [13] 0 0
Nebraska
Country [14] 0 0
United States of America
State/province [14] 0 0
Nevada
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oregon
Country [20] 0 0
United States of America
State/province [20] 0 0
South Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Caba
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Argentina
State/province [26] 0 0
Cordoba
Country [27] 0 0
Argentina
State/province [27] 0 0
La Rioja
Country [28] 0 0
Argentina
State/province [28] 0 0
Mendoza
Country [29] 0 0
Austria
State/province [29] 0 0
Oberosterreich
Country [30] 0 0
Austria
State/province [30] 0 0
Wien
Country [31] 0 0
Brazil
State/province [31] 0 0
Parana
Country [32] 0 0
Brazil
State/province [32] 0 0
Rio Grande Do Norte
Country [33] 0 0
Brazil
State/province [33] 0 0
Rio Grande Do Sul
Country [34] 0 0
Brazil
State/province [34] 0 0
Santa Catarina
Country [35] 0 0
Brazil
State/province [35] 0 0
Sao Paulo
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Sofia (stolitsa)
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Plovdiv
Country [38] 0 0
Canada
State/province [38] 0 0
British Columbia
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Quebec
Country [41] 0 0
Chile
State/province [41] 0 0
Araucania
Country [42] 0 0
Chile
State/province [42] 0 0
Region M. De Santiago
Country [43] 0 0
Chile
State/province [43] 0 0
Valparaiso
Country [44] 0 0
Colombia
State/province [44] 0 0
Antioquia
Country [45] 0 0
Colombia
State/province [45] 0 0
Atlantico
Country [46] 0 0
Colombia
State/province [46] 0 0
Cesar
Country [47] 0 0
Colombia
State/province [47] 0 0
Cordoba
Country [48] 0 0
Colombia
State/province [48] 0 0
Distrito Capital De Bogota
Country [49] 0 0
Colombia
State/province [49] 0 0
Valle Del Cauca
Country [50] 0 0
Czechia
State/province [50] 0 0
Brno-mesto
Country [51] 0 0
Czechia
State/province [51] 0 0
Novy Jicin
Country [52] 0 0
Czechia
State/province [52] 0 0
Olomouc
Country [53] 0 0
France
State/province [53] 0 0
Aisne
Country [54] 0 0
France
State/province [54] 0 0
Alsace
Country [55] 0 0
France
State/province [55] 0 0
Auvergne
Country [56] 0 0
France
State/province [56] 0 0
Bretagne
Country [57] 0 0
France
State/province [57] 0 0
Doubs
Country [58] 0 0
France
State/province [58] 0 0
Gironde
Country [59] 0 0
France
State/province [59] 0 0
Haute-Garonne
Country [60] 0 0
France
State/province [60] 0 0
Hauts-de-Seine
Country [61] 0 0
France
State/province [61] 0 0
Herault
Country [62] 0 0
France
State/province [62] 0 0
Loire-Atlantique
Country [63] 0 0
France
State/province [63] 0 0
Loiret
Country [64] 0 0
France
State/province [64] 0 0
Meurthe-et-Moselle
Country [65] 0 0
France
State/province [65] 0 0
Nord
Country [66] 0 0
France
State/province [66] 0 0
Rhone
Country [67] 0 0
France
State/province [67] 0 0
Somme
Country [68] 0 0
France
State/province [68] 0 0
Val-de-Marne
Country [69] 0 0
France
State/province [69] 0 0
Vaucluse
Country [70] 0 0
France
State/province [70] 0 0
Paris
Country [71] 0 0
Germany
State/province [71] 0 0
Baden-Wurttemberg
Country [72] 0 0
Germany
State/province [72] 0 0
Bayern
Country [73] 0 0
Germany
State/province [73] 0 0
Niedersachsen
Country [74] 0 0
Germany
State/province [74] 0 0
Nordrhein-Westfalen
Country [75] 0 0
Germany
State/province [75] 0 0
Rheinland-Pfalz
Country [76] 0 0
Germany
State/province [76] 0 0
Saarland
Country [77] 0 0
Germany
State/province [77] 0 0
Schleswig-Holstein
Country [78] 0 0
Germany
State/province [78] 0 0
Thuringen
Country [79] 0 0
Germany
State/province [79] 0 0
Berlin
Country [80] 0 0
Hungary
State/province [80] 0 0
Bacs-Kiskun
Country [81] 0 0
Hungary
State/province [81] 0 0
Gyor-Moson-Sopron
Country [82] 0 0
Hungary
State/province [82] 0 0
Pest
Country [83] 0 0
Hungary
State/province [83] 0 0
Budapest
Country [84] 0 0
Ireland
State/province [84] 0 0
Dublin
Country [85] 0 0
Ireland
State/province [85] 0 0
Limerick
Country [86] 0 0
Israel
State/province [86] 0 0
Afula
Country [87] 0 0
Israel
State/province [87] 0 0
Ashdod
Country [88] 0 0
Israel
State/province [88] 0 0
Beer Sheva
Country [89] 0 0
Israel
State/province [89] 0 0
Haifa
Country [90] 0 0
Israel
State/province [90] 0 0
Jerusalem
Country [91] 0 0
Israel
State/province [91] 0 0
Kfar Saba
Country [92] 0 0
Israel
State/province [92] 0 0
Petach-Tikwa
Country [93] 0 0
Israel
State/province [93] 0 0
Ramat Gan
Country [94] 0 0
Israel
State/province [94] 0 0
Tel Aviv
Country [95] 0 0
Israel
State/province [95] 0 0
Zerifin
Country [96] 0 0
Italy
State/province [96] 0 0
Emilia-Romagna
Country [97] 0 0
Italy
State/province [97] 0 0
Lombardia
Country [98] 0 0
Italy
State/province [98] 0 0
Napoli
Country [99] 0 0
Italy
State/province [99] 0 0
Pordenone
Country [100] 0 0
Italy
State/province [100] 0 0
Veneto
Country [101] 0 0
Italy
State/province [101] 0 0
Arezzo
Country [102] 0 0
Italy
State/province [102] 0 0
Bologna
Country [103] 0 0
Italy
State/province [103] 0 0
Catania
Country [104] 0 0
Italy
State/province [104] 0 0
Modena
Country [105] 0 0
Italy
State/province [105] 0 0
Roma
Country [106] 0 0
Italy
State/province [106] 0 0
Terni
Country [107] 0 0
Italy
State/province [107] 0 0
Udine
Country [108] 0 0
Japan
State/province [108] 0 0
Chiba
Country [109] 0 0
Japan
State/province [109] 0 0
Ehime
Country [110] 0 0
Japan
State/province [110] 0 0
Fukuoka
Country [111] 0 0
Japan
State/province [111] 0 0
Hokkaido
Country [112] 0 0
Japan
State/province [112] 0 0
Ishikawa
Country [113] 0 0
Japan
State/province [113] 0 0
Kanagawa
Country [114] 0 0
Japan
State/province [114] 0 0
Miyagi
Country [115] 0 0
Japan
State/province [115] 0 0
Nara
Country [116] 0 0
Japan
State/province [116] 0 0
Osaka
Country [117] 0 0
Japan
State/province [117] 0 0
Saitama
Country [118] 0 0
Japan
State/province [118] 0 0
Shizuoka
Country [119] 0 0
Japan
State/province [119] 0 0
Yamaguchi
Country [120] 0 0
Japan
State/province [120] 0 0
Hiroshima
Country [121] 0 0
Japan
State/province [121] 0 0
Miyazaki
Country [122] 0 0
Japan
State/province [122] 0 0
Nagasaki
Country [123] 0 0
Japan
State/province [123] 0 0
Tokyo
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Kyonggi-do
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Seoul
Country [126] 0 0
Netherlands
State/province [126] 0 0
Gelderland
Country [127] 0 0
Netherlands
State/province [127] 0 0
Limburg
Country [128] 0 0
Netherlands
State/province [128] 0 0
Noord-Brabant
Country [129] 0 0
Netherlands
State/province [129] 0 0
Noord-Holland
Country [130] 0 0
Netherlands
State/province [130] 0 0
Overijssel
Country [131] 0 0
Netherlands
State/province [131] 0 0
Zuid-Holland
Country [132] 0 0
New Zealand
State/province [132] 0 0
Bay Of Plenty
Country [133] 0 0
New Zealand
State/province [133] 0 0
Canterbury
Country [134] 0 0
New Zealand
State/province [134] 0 0
Auckland
Country [135] 0 0
Poland
State/province [135] 0 0
Kujawsko-pomorskie
Country [136] 0 0
Poland
State/province [136] 0 0
Lodzkie
Country [137] 0 0
Poland
State/province [137] 0 0
Mazowieckie
Country [138] 0 0
Poland
State/province [138] 0 0
Wielkopolskie
Country [139] 0 0
Poland
State/province [139] 0 0
Zachodniopomorskie
Country [140] 0 0
Puerto Rico
State/province [140] 0 0
San Juan
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Chelyabinskaya Oblast
Country [142] 0 0
Russian Federation
State/province [142] 0 0
Krasnoyarskiy Kray
Country [143] 0 0
Russian Federation
State/province [143] 0 0
Moskva
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Omskaya Oblast
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Samarskaya Oblast
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Sankt-Peterburg
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Tomskaya Oblast
Country [148] 0 0
Spain
State/province [148] 0 0
Barcelona
Country [149] 0 0
Spain
State/province [149] 0 0
Gerona
Country [150] 0 0
Spain
State/province [150] 0 0
Madrid
Country [151] 0 0
Spain
State/province [151] 0 0
Valenciana, Comunitat
Country [152] 0 0
Spain
State/province [152] 0 0
Caceres
Country [153] 0 0
Spain
State/province [153] 0 0
Malaga
Country [154] 0 0
Spain
State/province [154] 0 0
Sevilla
Country [155] 0 0
Taiwan
State/province [155] 0 0
Tainan
Country [156] 0 0
Taiwan
State/province [156] 0 0
Taichung
Country [157] 0 0
Taiwan
State/province [157] 0 0
Taipei
Country [158] 0 0
Turkey
State/province [158] 0 0
Izmir
Country [159] 0 0
Turkey
State/province [159] 0 0
Adana
Country [160] 0 0
Turkey
State/province [160] 0 0
Ankara
Country [161] 0 0
Turkey
State/province [161] 0 0
Istanbul
Country [162] 0 0
Ukraine
State/province [162] 0 0
Cherkaska Oblast
Country [163] 0 0
Ukraine
State/province [163] 0 0
Dnipropetrovska Oblast
Country [164] 0 0
Ukraine
State/province [164] 0 0
Ivano-Frankivska Oblast
Country [165] 0 0
Ukraine
State/province [165] 0 0
Kharkivska Oblast
Country [166] 0 0
Ukraine
State/province [166] 0 0
Kyivska Oblast
Country [167] 0 0
United Kingdom
State/province [167] 0 0
Bristol, City Of
Country [168] 0 0
United Kingdom
State/province [168] 0 0
Cambridgeshire
Country [169] 0 0
United Kingdom
State/province [169] 0 0
Devon
Country [170] 0 0
United Kingdom
State/province [170] 0 0
London, City Of
Country [171] 0 0
United Kingdom
State/province [171] 0 0
Somerset
Country [172] 0 0
United Kingdom
State/province [172] 0 0
Sutton
Country [173] 0 0
United Kingdom
State/province [173] 0 0
Worcestershire
Country [174] 0 0
United Kingdom
State/province [174] 0 0
Northwood

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT03834493
Trial related presentations / publications
Graff JN, Liang LW, Kim J, Stenzl A. KEYNOTE-641: a Phase III study of pembrolizumab plus enzalutamide for metastatic castration-resistant prostate cancer. Future Oncol. 2021 Aug;17(23):3017-3026. doi: 10.2217/fon-2020-1008. Epub 2021 May 28.
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03834493