Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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
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)
Query!
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)
Query!
Secondary ID [1]
0
0
MK-3475-641
Query!
Secondary ID [2]
0
0
3475-641
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Prostatic Neoplasms
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS was defined as the time from randomization to death due to any cause. The OS for all participants is presented.
Query!
Timepoint [1]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
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
Query!
Assessment method [2]
0
0
rPFS was defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurred first. The rPFS per PCWG-modified RECIST for all participants is presented.
Query!
Timepoint [2]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
Secondary outcome [1]
0
0
Time to Initiation of the First Subsequent Anti-cancer Therapy or Death (TFST)
Query!
Assessment method [1]
0
0
TFST was defined as time from randomization to initiation of the first subsequent anti-cancer therapy or death, whichever occurs first. The TFST for all participants is presented.
Query!
Timepoint [1]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
Secondary outcome [2]
0
0
Prostate-specific Antigen (PSA) Response Rate
Query!
Assessment method [2]
0
0
PSA response rate was defined as percentage of participants in the analysis population who have a negative change (decrease) in PSA level of =50% measured twice =3 weeks apart. The analysis was performed on participants who had baseline PSA measurements.
Query!
Timepoint [2]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
Secondary outcome [3]
0
0
Prostate-specific Antigen (PSA) Undetectable Rate
Query!
Assessment method [3]
0
0
PSA undetectable rate was defined as percentage of participants in the analysis population with PSA \<0.2 ng/mL during study treatment. The analysis was performed on participants who had baseline PSA measurements.
Query!
Timepoint [3]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
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
Query!
Assessment method [4]
0
0
OR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable \[NE\], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG).
Query!
Timepoint [4]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
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
Query!
Assessment method [5]
0
0
DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD per PCWG was the appearance of =2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for =6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment.
Query!
Timepoint [5]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
Secondary outcome [6]
0
0
Time to Prostate-specific Antigen (PSA) Progression
Query!
Assessment method [6]
0
0
Time from randomization to PSA progression. PSA progression date is defined as the date of 1) =25% increase and =2 ng/mL above the nadir, confirmed by a second value =3 weeks later if there is PSA decline from baseline, or 2) =25% increase and =2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline.
Query!
Timepoint [6]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
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
Query!
Assessment method [7]
0
0
Time from randomization to radiographic soft tissue progression per PCWG-modified RECIST 1.1
Query!
Timepoint [7]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
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)
Query!
Assessment method [8]
0
0
Time from randomization to pain progression. In this study, pain progression was assessed by participant responses to Item 3 of the BPI-SF and participant AQA Scores which are both assessed by participants daily for 7 consecutive days.
Query!
Timepoint [8]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
Secondary outcome [9]
0
0
Time to First Symptomatic Skeletal-related Event (SSRE)
Query!
Assessment method [9]
0
0
Time from randomization to the first SSRE. SSRE is defined as radiation to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathological fracture, spinal cord compression, or surgery to bone.
Query!
Timepoint [9]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
Secondary outcome [10]
0
0
Number of Participants Who Experience an Adverse Event (AE)
Query!
Assessment method [10]
0
0
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants who experienced an AE is presented.
Query!
Timepoint [10]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
Secondary outcome [11]
0
0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Query!
Assessment method [11]
0
0
An AE is defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. The number of participants who discontinued study treatment due to an AE is presented.
Query!
Timepoint [11]
0
0
Up to 40 months (through database cut-off date of 12-Dec-2022)
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
28/07/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/05/2024
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1244
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Query!
Recruitment hospital [1]
0
0
St. Vincent's Hospital ( Site 0158) - Darlinghurst
Query!
Recruitment hospital [2]
0
0
St George Hospital ( Site 0157) - Kogarah
Query!
Recruitment hospital [3]
0
0
Macquarie University ( Site 0151) - Macquarie University
Query!
Recruitment hospital [4]
0
0
Port Macquarie Base Hospital ( Site 0153) - Port Macquarie
Query!
Recruitment hospital [5]
0
0
Calvary Mater Newcastle ( Site 0148) - Waratah
Query!
Recruitment hospital [6]
0
0
Gallipoli Medical Research Foundation ( Site 0149) - Greenslopes
Query!
Recruitment hospital [7]
0
0
Gold Coast University Hospital ( Site 0150) - Southport
Query!
Recruitment hospital [8]
0
0
Royal Adelaide Hospital ( Site 0154) - Adelaide
Query!
Recruitment hospital [9]
0
0
Monash Health-Monash Medical Centre ( Site 0147) - Clayton
Query!
Recruitment hospital [10]
0
0
Fiona Stanley Hospital ( Site 0162) - Perth
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [3]
0
0
2109 - Macquarie University
Query!
Recruitment postcode(s) [4]
0
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [5]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [6]
0
0
4120 - Greenslopes
Query!
Recruitment postcode(s) [7]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [8]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [9]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [10]
0
0
6150 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Illinois
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Indiana
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Louisiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Massachusetts
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Michigan
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Montana
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Nebraska
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Nevada
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
New Jersey
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
New York
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
North Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Ohio
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Oregon
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
South Carolina
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Wisconsin
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Buenos Aires
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Caba
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
Santa Fe
Query!
Country [26]
0
0
Argentina
Query!
State/province [26]
0
0
Cordoba
Query!
Country [27]
0
0
Argentina
Query!
State/province [27]
0
0
La Rioja
Query!
Country [28]
0
0
Argentina
Query!
State/province [28]
0
0
Mendoza
Query!
Country [29]
0
0
Austria
Query!
State/province [29]
0
0
Oberosterreich
Query!
Country [30]
0
0
Austria
Query!
State/province [30]
0
0
Wien
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Parana
Query!
Country [32]
0
0
Brazil
Query!
State/province [32]
0
0
Rio Grande Do Norte
Query!
Country [33]
0
0
Brazil
Query!
State/province [33]
0
0
Rio Grande Do Sul
Query!
Country [34]
0
0
Brazil
Query!
State/province [34]
0
0
Santa Catarina
Query!
Country [35]
0
0
Brazil
Query!
State/province [35]
0
0
Sao Paulo
Query!
Country [36]
0
0
Bulgaria
Query!
State/province [36]
0
0
Sofia (stolitsa)
Query!
Country [37]
0
0
Bulgaria
Query!
State/province [37]
0
0
Plovdiv
Query!
Country [38]
0
0
Canada
Query!
State/province [38]
0
0
British Columbia
Query!
Country [39]
0
0
Canada
Query!
State/province [39]
0
0
Ontario
Query!
Country [40]
0
0
Canada
Query!
State/province [40]
0
0
Quebec
Query!
Country [41]
0
0
Chile
Query!
State/province [41]
0
0
Araucania
Query!
Country [42]
0
0
Chile
Query!
State/province [42]
0
0
Region M. De Santiago
Query!
Country [43]
0
0
Chile
Query!
State/province [43]
0
0
Valparaiso
Query!
Country [44]
0
0
Colombia
Query!
State/province [44]
0
0
Antioquia
Query!
Country [45]
0
0
Colombia
Query!
State/province [45]
0
0
Atlantico
Query!
Country [46]
0
0
Colombia
Query!
State/province [46]
0
0
Cesar
Query!
Country [47]
0
0
Colombia
Query!
State/province [47]
0
0
Cordoba
Query!
Country [48]
0
0
Colombia
Query!
State/province [48]
0
0
Distrito Capital De Bogota
Query!
Country [49]
0
0
Colombia
Query!
State/province [49]
0
0
Valle Del Cauca
Query!
Country [50]
0
0
Czechia
Query!
State/province [50]
0
0
Brno-mesto
Query!
Country [51]
0
0
Czechia
Query!
State/province [51]
0
0
Novy Jicin
Query!
Country [52]
0
0
Czechia
Query!
State/province [52]
0
0
Olomouc
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Aisne
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Alsace
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Auvergne
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Bretagne
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Doubs
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Gironde
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Haute-Garonne
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Hauts-de-Seine
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Herault
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Loire-Atlantique
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Loiret
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Meurthe-et-Moselle
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Nord
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Rhone
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Somme
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Val-de-Marne
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Vaucluse
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Paris
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Baden-Wurttemberg
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Bayern
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Niedersachsen
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Nordrhein-Westfalen
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Rheinland-Pfalz
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Saarland
Query!
Country [77]
0
0
Germany
Query!
State/province [77]
0
0
Schleswig-Holstein
Query!
Country [78]
0
0
Germany
Query!
State/province [78]
0
0
Thuringen
Query!
Country [79]
0
0
Germany
Query!
State/province [79]
0
0
Berlin
Query!
Country [80]
0
0
Hungary
Query!
State/province [80]
0
0
Bacs-Kiskun
Query!
Country [81]
0
0
Hungary
Query!
State/province [81]
0
0
Gyor-Moson-Sopron
Query!
Country [82]
0
0
Hungary
Query!
State/province [82]
0
0
Pest
Query!
Country [83]
0
0
Hungary
Query!
State/province [83]
0
0
Budapest
Query!
Country [84]
0
0
Ireland
Query!
State/province [84]
0
0
Dublin
Query!
Country [85]
0
0
Ireland
Query!
State/province [85]
0
0
Limerick
Query!
Country [86]
0
0
Israel
Query!
State/province [86]
0
0
Afula
Query!
Country [87]
0
0
Israel
Query!
State/province [87]
0
0
Ashdod
Query!
Country [88]
0
0
Israel
Query!
State/province [88]
0
0
Beer Sheva
Query!
Country [89]
0
0
Israel
Query!
State/province [89]
0
0
Haifa
Query!
Country [90]
0
0
Israel
Query!
State/province [90]
0
0
Jerusalem
Query!
Country [91]
0
0
Israel
Query!
State/province [91]
0
0
Kfar Saba
Query!
Country [92]
0
0
Israel
Query!
State/province [92]
0
0
Petach-Tikwa
Query!
Country [93]
0
0
Israel
Query!
State/province [93]
0
0
Ramat Gan
Query!
Country [94]
0
0
Israel
Query!
State/province [94]
0
0
Tel Aviv
Query!
Country [95]
0
0
Israel
Query!
State/province [95]
0
0
Zerifin
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Emilia-Romagna
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Lombardia
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Napoli
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Pordenone
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
Veneto
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
Arezzo
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Bologna
Query!
Country [103]
0
0
Italy
Query!
State/province [103]
0
0
Catania
Query!
Country [104]
0
0
Italy
Query!
State/province [104]
0
0
Modena
Query!
Country [105]
0
0
Italy
Query!
State/province [105]
0
0
Roma
Query!
Country [106]
0
0
Italy
Query!
State/province [106]
0
0
Terni
Query!
Country [107]
0
0
Italy
Query!
State/province [107]
0
0
Udine
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Chiba
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Ehime
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Fukuoka
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Hokkaido
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Ishikawa
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Kanagawa
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Miyagi
Query!
Country [115]
0
0
Japan
Query!
State/province [115]
0
0
Nara
Query!
Country [116]
0
0
Japan
Query!
State/province [116]
0
0
Osaka
Query!
Country [117]
0
0
Japan
Query!
State/province [117]
0
0
Saitama
Query!
Country [118]
0
0
Japan
Query!
State/province [118]
0
0
Shizuoka
Query!
Country [119]
0
0
Japan
Query!
State/province [119]
0
0
Yamaguchi
Query!
Country [120]
0
0
Japan
Query!
State/province [120]
0
0
Hiroshima
Query!
Country [121]
0
0
Japan
Query!
State/province [121]
0
0
Miyazaki
Query!
Country [122]
0
0
Japan
Query!
State/province [122]
0
0
Nagasaki
Query!
Country [123]
0
0
Japan
Query!
State/province [123]
0
0
Tokyo
Query!
Country [124]
0
0
Korea, Republic of
Query!
State/province [124]
0
0
Kyonggi-do
Query!
Country [125]
0
0
Korea, Republic of
Query!
State/province [125]
0
0
Seoul
Query!
Country [126]
0
0
Netherlands
Query!
State/province [126]
0
0
Gelderland
Query!
Country [127]
0
0
Netherlands
Query!
State/province [127]
0
0
Limburg
Query!
Country [128]
0
0
Netherlands
Query!
State/province [128]
0
0
Noord-Brabant
Query!
Country [129]
0
0
Netherlands
Query!
State/province [129]
0
0
Noord-Holland
Query!
Country [130]
0
0
Netherlands
Query!
State/province [130]
0
0
Overijssel
Query!
Country [131]
0
0
Netherlands
Query!
State/province [131]
0
0
Zuid-Holland
Query!
Country [132]
0
0
New Zealand
Query!
State/province [132]
0
0
Bay Of Plenty
Query!
Country [133]
0
0
New Zealand
Query!
State/province [133]
0
0
Canterbury
Query!
Country [134]
0
0
New Zealand
Query!
State/province [134]
0
0
Auckland
Query!
Country [135]
0
0
Poland
Query!
State/province [135]
0
0
Kujawsko-pomorskie
Query!
Country [136]
0
0
Poland
Query!
State/province [136]
0
0
Lodzkie
Query!
Country [137]
0
0
Poland
Query!
State/province [137]
0
0
Mazowieckie
Query!
Country [138]
0
0
Poland
Query!
State/province [138]
0
0
Wielkopolskie
Query!
Country [139]
0
0
Poland
Query!
State/province [139]
0
0
Zachodniopomorskie
Query!
Country [140]
0
0
Puerto Rico
Query!
State/province [140]
0
0
San Juan
Query!
Country [141]
0
0
Russian Federation
Query!
State/province [141]
0
0
Chelyabinskaya Oblast
Query!
Country [142]
0
0
Russian Federation
Query!
State/province [142]
0
0
Krasnoyarskiy Kray
Query!
Country [143]
0
0
Russian Federation
Query!
State/province [143]
0
0
Moskva
Query!
Country [144]
0
0
Russian Federation
Query!
State/province [144]
0
0
Omskaya Oblast
Query!
Country [145]
0
0
Russian Federation
Query!
State/province [145]
0
0
Samarskaya Oblast
Query!
Country [146]
0
0
Russian Federation
Query!
State/province [146]
0
0
Sankt-Peterburg
Query!
Country [147]
0
0
Russian Federation
Query!
State/province [147]
0
0
Tomskaya Oblast
Query!
Country [148]
0
0
Spain
Query!
State/province [148]
0
0
Barcelona
Query!
Country [149]
0
0
Spain
Query!
State/province [149]
0
0
Gerona
Query!
Country [150]
0
0
Spain
Query!
State/province [150]
0
0
Madrid
Query!
Country [151]
0
0
Spain
Query!
State/province [151]
0
0
Valenciana, Comunitat
Query!
Country [152]
0
0
Spain
Query!
State/province [152]
0
0
Caceres
Query!
Country [153]
0
0
Spain
Query!
State/province [153]
0
0
Malaga
Query!
Country [154]
0
0
Spain
Query!
State/province [154]
0
0
Sevilla
Query!
Country [155]
0
0
Taiwan
Query!
State/province [155]
0
0
Tainan
Query!
Country [156]
0
0
Taiwan
Query!
State/province [156]
0
0
Taichung
Query!
Country [157]
0
0
Taiwan
Query!
State/province [157]
0
0
Taipei
Query!
Country [158]
0
0
Turkey
Query!
State/province [158]
0
0
Izmir
Query!
Country [159]
0
0
Turkey
Query!
State/province [159]
0
0
Adana
Query!
Country [160]
0
0
Turkey
Query!
State/province [160]
0
0
Ankara
Query!
Country [161]
0
0
Turkey
Query!
State/province [161]
0
0
Istanbul
Query!
Country [162]
0
0
Ukraine
Query!
State/province [162]
0
0
Cherkaska Oblast
Query!
Country [163]
0
0
Ukraine
Query!
State/province [163]
0
0
Dnipropetrovska Oblast
Query!
Country [164]
0
0
Ukraine
Query!
State/province [164]
0
0
Ivano-Frankivska Oblast
Query!
Country [165]
0
0
Ukraine
Query!
State/province [165]
0
0
Kharkivska Oblast
Query!
Country [166]
0
0
Ukraine
Query!
State/province [166]
0
0
Kyivska Oblast
Query!
Country [167]
0
0
United Kingdom
Query!
State/province [167]
0
0
Bristol, City Of
Query!
Country [168]
0
0
United Kingdom
Query!
State/province [168]
0
0
Cambridgeshire
Query!
Country [169]
0
0
United Kingdom
Query!
State/province [169]
0
0
Devon
Query!
Country [170]
0
0
United Kingdom
Query!
State/province [170]
0
0
London, City Of
Query!
Country [171]
0
0
United Kingdom
Query!
State/province [171]
0
0
Somerset
Query!
Country [172]
0
0
United Kingdom
Query!
State/province [172]
0
0
Sutton
Query!
Country [173]
0
0
United Kingdom
Query!
State/province [173]
0
0
Worcestershire
Query!
Country [174]
0
0
United Kingdom
Query!
State/province [174]
0
0
Northwood
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Merck Sharp & Dohme LLC
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03834493
Query!
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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Medical Director
Query!
Address
0
0
Merck Sharp & Dohme LLC
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/93/NCT03834493/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/93/NCT03834493/Prot_SAP_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03834493