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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Other interventions - 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.


Other interventions: Pembrolizumab
IV infusion

Treatment: Drugs: Enzalutamide
Capsules/Tablets

Treatment: Drugs: Placebo
IV infusion
Intervention code [1] 0 0
Other interventions
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
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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
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Cordoba
Country [27] 0 0
Argentina
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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
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Canada
State/province [38] 0 0
British Columbia
Country [39] 0 0
Canada
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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
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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
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Alsace
Country [55] 0 0
France
State/province [55] 0 0
Auvergne
Country [56] 0 0
France
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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/ct2/show/NCT03834493
Trial related presentations / publications
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/ct2/show/NCT03834493