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/NCT04191096
Registration number
NCT04191096
Ethics application status
Date submitted
5/12/2019
Date registered
9/12/2019
Titles & IDs
Public title
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)
Query!
Scientific title
A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)
Query!
Secondary ID [1]
0
0
MK-3475-991
Query!
Secondary ID [2]
0
0
3475-991
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Metastatic Hormone-Sensitive Prostate Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Prostate
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Allergies
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Androgen Deprivation Therapy (ADT)
Other interventions - Placebo
Experimental: Pembrolizumab + Enzalutamide + ADT - Starting on Day 1 of each 21-day cycle, participants receive 200 mg pembrolizumab IV every 3 weeks (Q3W) for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a luteinizing-hormone releasing hormone (LHRH) agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.
Placebo comparator: Placebo + Enzalutamide + ADT - Starting on Day 1 of each 21-day cycle, participants receive placebo IV Q3W for up to 35 cycles (approximately 2 years), plus 160 mg enzalutamide taken orally once daily, while maintaining continuous ADT with a LHRH agonist or antagonist during study treatment. Participants will continue to receive enzalutamide and ADT until criteria for discontinuation are met.
Treatment: Other: Pembrolizumab
Pembrolizumab is administered as an IV infusion at 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
Treatment: Drugs: Enzalutamide
Enzalutamide is administered orally as capsules/tablets at a dosage of 160 mg daily. Enzalutamide is administered continuously until criteria for discontinuation are met.
Treatment: Drugs: Androgen Deprivation Therapy (ADT)
Stable regimen of ADT (LHRH agonist or antagonist) at a dose and frequency of administration that is consistent with the local product label.
Other interventions: Placebo
Placebo infusion solution is administered as an IV infusion on Day 1 of each 21-day cycle for up to 35 cycles.
Query!
Intervention code [1]
0
0
Treatment: Other
Query!
Intervention code [2]
0
0
Treatment: Drugs
Query!
Intervention code [3]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
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 (BICR)
Query!
Assessment method [1]
0
0
rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per modified RECIST 1.1 was =20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of =2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for =6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment.
Query!
Timepoint [1]
0
0
Up to approximately 32 months
Query!
Primary outcome [2]
0
0
Overall Survival (OS)
Query!
Assessment method [2]
0
0
OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up.
Query!
Timepoint [2]
0
0
Up to approximately 32 months
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 the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product limit (Kaplan-Meier) method for censored data. Participants without documented event at time of analysis will be censored at the date of last known time to have not received subsequent new anti-cancer therapy.
Query!
Timepoint [1]
0
0
Up to Approximately 32 months
Query!
Secondary outcome [2]
0
0
Time to First Symptomatic Skeletal-related Event (TTSSRE)
Query!
Assessment method [2]
0
0
TTSSRE was the time from randomization to the first symptomatic skeletal-related event defined as: use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms, occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral), occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention, whichever occurs first. The TTSSRE was calculated using the Kaplan-Meier method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment.
Query!
Timepoint [2]
0
0
Up to Approximately 32 months
Query!
Secondary outcome [3]
0
0
Time to Prostate-specific Antigen (PSA) Progression
Query!
Assessment method [3]
0
0
Time to PSA progression was the time from randomization to PSA progression. The PSA progression date was 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. Time to PSA was calculated using Kaplan-Meier method for censored data. Participants without PSA progression were censored at the last PSA date.
Query!
Timepoint [3]
0
0
Up to Approximately 32 months
Query!
Secondary outcome [4]
0
0
Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of PCWG-Modified RECIST 1.1 as Assessed by BICR
Query!
Assessment method [4]
0
0
The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of =5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment.
Query!
Timepoint [4]
0
0
Up to Approximately 32 months
Query!
Secondary outcome [5]
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 Use
Query!
Assessment method [5]
0
0
TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF. Pain progression was defined as: 1) For participants asymptomatic at baseline: a \>2-point change from baseline in the average BPI-SF item 3 score at 2 consecutive visits or initiation of opioid use for pain 2) For participants symptomatic at baseline (average BPI-SF Item 3 score \>0 and/or currently taking opioids; a \>2-point change from baseline in the average BPI-SF Item 3 score and the average worst pain score \>4 and no decrease in average opioid use. TTPP was calculated using the Kaplan-Meier method for censored data. Participants who had \> 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.
Query!
Timepoint [5]
0
0
Up to Approximately 32 months
Query!
Secondary outcome [6]
0
0
Time From Randomization to Disease Progression as Determined by Investigator Assessment After Next-line of Therapy or Death From Any Cause, Whichever Occurs First (PFS2)
Query!
Assessment method [6]
0
0
PFS2 was defined as the time from randomization to disease progression as determined by investigator assessment of radiological or clinical progression after next-line of therapy or death from any cause, whichever occurs first.
Query!
Timepoint [6]
0
0
Up to Approximately 32 months
Query!
Secondary outcome [7]
0
0
Prostate-specific Antigen (PSA) Response Rate
Query!
Assessment method [7]
0
0
PSA response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by \>50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed \>3 weeks from the original response.
Query!
Timepoint [7]
0
0
Up to Approximately 32 Months
Query!
Secondary outcome [8]
0
0
Prostate-specific Antigen (PSA) Undetectable
Query!
Assessment method [8]
0
0
PSA undetectable rate was defined as the percentage of participants with detectable PSA (\> 0.2 ng/mL) at baseline, which becomes undetectable (\< 0.2 ng/mL) during study treatment.
Query!
Timepoint [8]
0
0
Up to Approximately 32 Months
Query!
Secondary outcome [9]
0
0
Objective Response Rate (ORR) Per PCWG-Modified RECIST 1.1 as Assessed by BICR
Query!
Assessment method [9]
0
0
ORR 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 base 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 [9]
0
0
Up to Approximately 32 Months
Query!
Secondary outcome [10]
0
0
Duration of Response (DOR) Per PCWG- Modified RECIST 1.1 as Assessed by BICR
Query!
Assessment method [10]
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 a 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.
Query!
Timepoint [10]
0
0
Up to Approximately 32 Months
Query!
Secondary outcome [11]
0
0
Number of Participants Who Experience an Adverse Event (AE)
Query!
Assessment method [11]
0
0
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. Participants who experienced an AE will be reported for each arm.
Query!
Timepoint [11]
0
0
Up to Approximately 59 Months
Query!
Secondary outcome [12]
0
0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Query!
Assessment method [12]
0
0
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE will be reported for each arm.
Query!
Timepoint [12]
0
0
Up to Approximately 59 Months
Query!
Eligibility
Key inclusion criteria
* Male participants with histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has metastatic disease assessed by investigator and verified by BICR by either =2 bone lesions on bone scan and/or visceral disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Willing to maintain continuous Androgen Deprivation Therapy (ADT) with a luteinizing-hormone releasing hormone (LHRH) agonists or antagonists during study treatment or have a history of bilateral orchiectomy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 10 days of randomization
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
* Has adequate organ function
* 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
* Male participants must agree to the following during the intervention period and for at least 120 days after the last dose of study intervention: Refrain from donating sperm PLUS either be abstinent from heterosexual intercourse and agree to remain abstinent OR agree to use contraception, unless confirmed to be azoospermic
* Male participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
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 (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Has known or suspected central nervous system (CNS) metastases and/or carcinomatous meningitis
* 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 had myocardial infarction or uncontrolled angina within 6 months prior to randomization, or has New York Heart Association class III or IV congestive heart failure or a history of New York Heart Association class III or IV congestive heart failure
* 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 a history of clinically significant ventricular arrhythmias
* Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
* Has received prior ADT as neoadjuvant/adjuvant therapy for non-metastatic prostate cancer for >39 months in duration or within 9 months prior to randomization or with evidence of disease progression while receiving ADT
* Has had prior treatment with a next generation hormonal agent (eg, abiraterone, enzalutamide, apalutamide, darolutamide)
* 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-programmed cell death-ligand 2 (anti PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Has received a live vaccine within 30 days prior to randomization
* Has a "superscan" bone scan
* Has had an allogenic tissue/solid organ transplant
* 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 received any prior pharmacotherapy, radiation therapy or surgery for metastatic prostate cancer with the following exceptions:
1. Up to 3 months of ADT or orchiectomy with or without concurrent first-generation antiandrogens, if patient was not treated with docetaxel
2. May have 1 course of palliative radiation or surgical therapy to treat symptoms resulting from metastatic disease if it was administered at least 4 weeks prior to randomization
3. For participants with low volume metastatic disease, may have 1 course of definitive radiotherapy if it was administered at least 4 weeks prior to randomization
4. Up to 6 cycles of docetaxel therapy with final treatment administration completed within 2 months of randomization and no evidence of disease progression. In these participants up to 6 months of ADT permitted
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 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
12/02/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
15/06/2026
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1251
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Chris OBrien Lifehouse ( Site 0300) - Camperdown
Query!
Recruitment hospital [2]
0
0
Port Macquarie Base Hospital ( Site 0301) - Port Macquarie
Query!
Recruitment hospital [3]
0
0
Riverina Cancer Care Center ( Site 0302) - Wagga Wagga
Query!
Recruitment hospital [4]
0
0
Gallipoli Medical Research Foundation ( Site 0309) - Greenslopes
Query!
Recruitment hospital [5]
0
0
John Flynn Hospital & Medical Centre ( Site 0308) - Tugun
Query!
Recruitment hospital [6]
0
0
Box Hill Hospital ( Site 0304) - Box Hill
Query!
Recruitment hospital [7]
0
0
Monash Health ( Site 0305) - Clayton
Query!
Recruitment hospital [8]
0
0
Peter MacCallum Cancer Centre ( Site 0306) - Melbourne
Query!
Recruitment hospital [9]
0
0
Fiona Stanley Hospital ( Site 0311) - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [3]
0
0
2650 - Wagga Wagga
Query!
Recruitment postcode(s) [4]
0
0
4120 - Greenslopes
Query!
Recruitment postcode(s) [5]
0
0
4224 - Tugun
Query!
Recruitment postcode(s) [6]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [7]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [8]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [9]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alaska
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
District of Columbia
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
Kansas
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Maryland
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Montana
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nevada
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New York
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
North Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Ohio
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Virginia
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Washington
Query!
Country [20]
0
0
Austria
Query!
State/province [20]
0
0
Oberosterreich
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Salzburg
Query!
Country [22]
0
0
Austria
Query!
State/province [22]
0
0
Wien
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Ceara
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Parana
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Rio Grande Do Sul
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Santa Catarina
Query!
Country [27]
0
0
Brazil
Query!
State/province [27]
0
0
Sao Paulo
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
Ontario
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Quebec
Query!
Country [30]
0
0
Chile
Query!
State/province [30]
0
0
Araucania
Query!
Country [31]
0
0
Chile
Query!
State/province [31]
0
0
Coquimbo
Query!
Country [32]
0
0
Chile
Query!
State/province [32]
0
0
Maule
Query!
Country [33]
0
0
Chile
Query!
State/province [33]
0
0
Region M. De Santiago
Query!
Country [34]
0
0
Chile
Query!
State/province [34]
0
0
Valparaiso
Query!
Country [35]
0
0
China
Query!
State/province [35]
0
0
Beijing
Query!
Country [36]
0
0
China
Query!
State/province [36]
0
0
Zhejiang
Query!
Country [37]
0
0
Colombia
Query!
State/province [37]
0
0
Atlantico
Query!
Country [38]
0
0
Colombia
Query!
State/province [38]
0
0
Cesar
Query!
Country [39]
0
0
Colombia
Query!
State/province [39]
0
0
Distrito Capital De Bogota
Query!
Country [40]
0
0
Colombia
Query!
State/province [40]
0
0
Valle Del Cauca
Query!
Country [41]
0
0
Denmark
Query!
State/province [41]
0
0
Hovedstaden
Query!
Country [42]
0
0
Denmark
Query!
State/province [42]
0
0
Nordjylland
Query!
Country [43]
0
0
Denmark
Query!
State/province [43]
0
0
Syddanmark
Query!
Country [44]
0
0
Finland
Query!
State/province [44]
0
0
Mellersta Finland
Query!
Country [45]
0
0
Finland
Query!
State/province [45]
0
0
Pirkanmaa
Query!
Country [46]
0
0
Finland
Query!
State/province [46]
0
0
Varsinais-Suomi
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Auvergne
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Bas-Rhin
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Bretagne
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Cote-d Or
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Doubs
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Gironde
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Hauts-de-Seine
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Ille-et-Vilaine
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Marne
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Meurthe-et-Moselle
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Nord-Pas-de-Calais
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Rhone
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Val-de-Marne
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Baden-Wurttemberg
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Bayern
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Niedersachsen
Query!
Country [63]
0
0
Germany
Query!
State/province [63]
0
0
Sachsen-Anhalt
Query!
Country [64]
0
0
Germany
Query!
State/province [64]
0
0
Sachsen
Query!
Country [65]
0
0
Germany
Query!
State/province [65]
0
0
Berlin
Query!
Country [66]
0
0
Germany
Query!
State/province [66]
0
0
Hamburg
Query!
Country [67]
0
0
Ireland
Query!
State/province [67]
0
0
Cork
Query!
Country [68]
0
0
Ireland
Query!
State/province [68]
0
0
Dublin
Query!
Country [69]
0
0
Ireland
Query!
State/province [69]
0
0
Limerick
Query!
Country [70]
0
0
Ireland
Query!
State/province [70]
0
0
Waterford
Query!
Country [71]
0
0
Israel
Query!
State/province [71]
0
0
Haifa
Query!
Country [72]
0
0
Israel
Query!
State/province [72]
0
0
Jerusalem
Query!
Country [73]
0
0
Israel
Query!
State/province [73]
0
0
Kfar Saba
Query!
Country [74]
0
0
Israel
Query!
State/province [74]
0
0
Petach Tikva
Query!
Country [75]
0
0
Israel
Query!
State/province [75]
0
0
Tel Aviv
Query!
Country [76]
0
0
Israel
Query!
State/province [76]
0
0
Zerifin
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Emilia-Romagna
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Lombardia
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Pordenone
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Bari
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Catania
Query!
Country [82]
0
0
Italy
Query!
State/province [82]
0
0
Milano
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Napoli
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Roma
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Terni
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Verona
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Chiba
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Ehime
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Hokkaido
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Kanagawa
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Nara
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Osaka
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Saitama
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Shizuoka
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Yamaguchi
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Fukuoka
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Nagano
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Tokyo
Query!
Country [99]
0
0
Korea, Republic of
Query!
State/province [99]
0
0
Jeonranamdo
Query!
Country [100]
0
0
Korea, Republic of
Query!
State/province [100]
0
0
Kyonggi-do
Query!
Country [101]
0
0
Korea, Republic of
Query!
State/province [101]
0
0
Taegu-Kwangyokshi
Query!
Country [102]
0
0
Korea, Republic of
Query!
State/province [102]
0
0
Seoul
Query!
Country [103]
0
0
Mexico
Query!
State/province [103]
0
0
Chiapas
Query!
Country [104]
0
0
Mexico
Query!
State/province [104]
0
0
Jalisco
Query!
Country [105]
0
0
Mexico
Query!
State/province [105]
0
0
Chihuahua
Query!
Country [106]
0
0
Mexico
Query!
State/province [106]
0
0
Mexico City
Query!
Country [107]
0
0
Mexico
Query!
State/province [107]
0
0
Queretaro
Query!
Country [108]
0
0
Netherlands
Query!
State/province [108]
0
0
Gelderland
Query!
Country [109]
0
0
Netherlands
Query!
State/province [109]
0
0
Noord-Holland
Query!
Country [110]
0
0
Netherlands
Query!
State/province [110]
0
0
Overijssel
Query!
Country [111]
0
0
Netherlands
Query!
State/province [111]
0
0
Utrecht
Query!
Country [112]
0
0
Netherlands
Query!
State/province [112]
0
0
Zuid-Holland
Query!
Country [113]
0
0
New Zealand
Query!
State/province [113]
0
0
Auckland
Query!
Country [114]
0
0
Peru
Query!
State/province [114]
0
0
Ariqipa
Query!
Country [115]
0
0
Peru
Query!
State/province [115]
0
0
La Libertad
Query!
Country [116]
0
0
Peru
Query!
State/province [116]
0
0
Lima
Query!
Country [117]
0
0
Poland
Query!
State/province [117]
0
0
Kujawsko-pomorskie
Query!
Country [118]
0
0
Poland
Query!
State/province [118]
0
0
Malopolskie
Query!
Country [119]
0
0
Poland
Query!
State/province [119]
0
0
Mazowieckie
Query!
Country [120]
0
0
Poland
Query!
State/province [120]
0
0
Podkarpackie
Query!
Country [121]
0
0
Poland
Query!
State/province [121]
0
0
Slaskie
Query!
Country [122]
0
0
Poland
Query!
State/province [122]
0
0
Wielkopolskie
Query!
Country [123]
0
0
Poland
Query!
State/province [123]
0
0
Zachodniopomorskie
Query!
Country [124]
0
0
Russian Federation
Query!
State/province [124]
0
0
Krasnoyarskiy Kray
Query!
Country [125]
0
0
Russian Federation
Query!
State/province [125]
0
0
Moskva
Query!
Country [126]
0
0
Russian Federation
Query!
State/province [126]
0
0
Nizhegorodskaya Oblast
Query!
Country [127]
0
0
Russian Federation
Query!
State/province [127]
0
0
Omskaya Oblast
Query!
Country [128]
0
0
Spain
Query!
State/province [128]
0
0
Barcelona
Query!
Country [129]
0
0
Spain
Query!
State/province [129]
0
0
Gerona
Query!
Country [130]
0
0
Spain
Query!
State/province [130]
0
0
Lugo
Query!
Country [131]
0
0
Spain
Query!
State/province [131]
0
0
Madrid
Query!
Country [132]
0
0
Spain
Query!
State/province [132]
0
0
Sevilla
Query!
Country [133]
0
0
Switzerland
Query!
State/province [133]
0
0
Grisons
Query!
Country [134]
0
0
Switzerland
Query!
State/province [134]
0
0
Sankt Gallen
Query!
Country [135]
0
0
Switzerland
Query!
State/province [135]
0
0
Vaud
Query!
Country [136]
0
0
Switzerland
Query!
State/province [136]
0
0
Zurich
Query!
Country [137]
0
0
Taiwan
Query!
State/province [137]
0
0
Kaohsiung
Query!
Country [138]
0
0
Taiwan
Query!
State/province [138]
0
0
Tainan
Query!
Country [139]
0
0
Taiwan
Query!
State/province [139]
0
0
Taipei
Query!
Country [140]
0
0
Taiwan
Query!
State/province [140]
0
0
Taoyuan
Query!
Country [141]
0
0
Thailand
Query!
State/province [141]
0
0
Krung Thep Maha Nakhon
Query!
Country [142]
0
0
Thailand
Query!
State/province [142]
0
0
Khon Kaen
Query!
Country [143]
0
0
Turkey
Query!
State/province [143]
0
0
Adana
Query!
Country [144]
0
0
Turkey
Query!
State/province [144]
0
0
Ankara
Query!
Country [145]
0
0
Turkey
Query!
State/province [145]
0
0
Istanbul
Query!
Country [146]
0
0
Turkey
Query!
State/province [146]
0
0
Izmir
Query!
Country [147]
0
0
Turkey
Query!
State/province [147]
0
0
Konya
Query!
Country [148]
0
0
United Kingdom
Query!
State/province [148]
0
0
Aberdeen City
Query!
Country [149]
0
0
United Kingdom
Query!
State/province [149]
0
0
Cornwall
Query!
Country [150]
0
0
United Kingdom
Query!
State/province [150]
0
0
London, City Of
Query!
Country [151]
0
0
United Kingdom
Query!
State/province [151]
0
0
Cardiff
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
This study will assess the efficacy and safety of pembrolizumab plus enzalutamide plus Androgen Deprivation Therapy (ADT) versus placebo plus enzalutamide plus ADT in participants with mHSPC. The primary hypothesis is that in participants with mHSPC, the combination of pembrolizumab plus enzalutamide plus ADT is superior to placebo plus enzalutamide plus ADT with respect to 1) radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR) and 2) overall survival (OS). As of 19-JAN-2023, the study was unblinded and all study participants stopped ongoing treatment with pembrolizumab/placebo and will continue to receive Standard of Care treatment until meeting protocol-specified discontinuation criteria if deriving clinical benefit. Safety analysis will be performed at the end of the study; there will be no further analyses for efficacy and electronic patient-reported outcome (ePRO) endpoints collected from participants beyond the IA1 cutoff date. All study participants will stop ongoing treatment with pembrolizumab/placebo. Exceptions may be requested for study participants who, in the assessment of their study physician, are benefitting from the combination of enzalutamide and pembrolizumab, after consulting with the Sponsor. All other study participants should be discontinued from study and be offered standard of care (SOC) treatment as deemed necessary by the Investigator. If enzalutamide as SOC is not accessible off study to the participant, central sourcing may continue. As of Amendment 04, disease progression will no longer be centrally verified, participants will only be assessed locally. As of Amendment 4, Second Course treatment is not an option for participants. There are currently no participants in the Second Course Phase.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04191096
Query!
Trial related presentations / publications
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/96/NCT04191096/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/96/NCT04191096/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/NCT04191096