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

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

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

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

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


Treatment: Other: Pembrolizumab
IV infusion

Treatment: Drugs: Enzalutamide
Capsules/Tablets

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

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

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



* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
* Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to randomization
* Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI)
* Has met one of the following criteria with regard to abiraterone acetate exposure: (1) is abiraterone-naïve; (2) received prior abiraterone acetate for the treatment of mHSPC or mCRPC, for a minimum of 4 weeks and not progressed while on treatment; or (3) received prior abiraterone acetate for the treatment of mHSPC or mCRPC and progressed on treatment after a minimum of 8 weeks treatment (minimum 14 weeks for those with bone progression)
* Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
* Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization
* Participants must agree to the following during the study treatment period and for at least 90 days after the last dose of enzalutamide: Refrain from donating sperm, plus EITHER be abstinent OR must agree to use male condom
* Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications
* Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules
* Has an active infection (including tuberculosis) requiring systemic therapy
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
* Has known active human immunodeficiency virus (HIV), concurrent active hepatitis B virus (HBV) or known active hepatitis C virus (HCV) infection
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has hypersensitivity to pembrolizumab and/or enzalutamide and/or any of their excipients
* Has a history of seizure or any condition that may predispose to seizure
* Has a history of loss of consciousness within 12 months of screening
* Has hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or uncontrolled hypertension (systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg) at the screening visit
* Has bradycardia (heart rate of <50 beats per minute) on the screening electrocardiogram (ECG)
* Has history of prostate cancer progression on ketoconazole
* Has had prior treatment with enzalutamide, apalutamide, darolutamide or cytochrome P450 (CYP) 17 inhibitor other than abiraterone acetate
* Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
* Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
* Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
* Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization
* Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (eg, saw palmetto) prior to randomization
* Has received a live or live attenuated vaccine within 30 days prior to randomization
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment
* Has a "superscan" bone scan
* Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of enzalutamide
* Has had an allogenic tissue/solid organ transplant

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

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/05/2026
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
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Montana
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United States of America
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Nebraska
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Nevada
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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South Carolina
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Virginia
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Wisconsin
Country [23] 0 0
Argentina
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Buenos Aires
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Caba
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Santa Fe
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Cordoba
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La Rioja
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Mendoza
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Austria
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Oberosterreich
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Austria
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Wien
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Brazil
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Parana
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Brazil
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Rio Grande Do Norte
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Brazil
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Rio Grande Do Sul
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Brazil
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Santa Catarina
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Sao Paulo
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Sofia (stolitsa)
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Region M. De Santiago
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Cesar
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Doubs
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Gironde
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Hauts-de-Seine
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Herault
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Loire-Atlantique
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France
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Loiret
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France
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Meurthe-et-Moselle
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France
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Nord
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France
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Rhone
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Somme
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France
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Val-de-Marne
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France
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Vaucluse
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France
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Paris
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Rheinland-Pfalz
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Germany
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Saarland
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Germany
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Schleswig-Holstein
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Germany
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Thuringen
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Germany
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Berlin
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Hungary
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Bacs-Kiskun
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Gyor-Moson-Sopron
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Hungary
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Pest
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Budapest
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Dublin
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Limerick
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Israel
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Afula
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Israel
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Ashdod
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Israel
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Beer Sheva
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petach-Tikwa
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Israel
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Zerifin
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Italy
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Emilia-Romagna
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Italy
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Lombardia
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Italy
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Napoli
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Italy
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Pordenone
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Italy
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Veneto
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Italy
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Arezzo
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Italy
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Bologna
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Italy
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Catania
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Italy
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Modena
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Italy
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Roma
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Italy
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Terni
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Italy
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Udine
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hokkaido
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Japan
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Ishikawa
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Japan
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Kanagawa
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Japan
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Miyagi
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Japan
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Nara
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Yamaguchi
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Japan
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Hiroshima
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Japan
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Miyazaki
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Japan
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Nagasaki
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Japan
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Tokyo
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Korea, Republic of
State/province [124] 0 0
Kyonggi-do
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Korea, Republic of
State/province [125] 0 0
Seoul
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Netherlands
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Gelderland
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Netherlands
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Limburg
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Netherlands
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Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
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Overijssel
Country [131] 0 0
Netherlands
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Zuid-Holland
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New Zealand
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Bay Of Plenty
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New Zealand
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Canterbury
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New Zealand
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Auckland
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Poland
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Kujawsko-pomorskie
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Poland
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Lodzkie
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Poland
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Mazowieckie
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Poland
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Wielkopolskie
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Poland
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Zachodniopomorskie
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Puerto Rico
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San Juan
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Russian Federation
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Chelyabinskaya Oblast
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Russian Federation
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Krasnoyarskiy Kray
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Russian Federation
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Moskva
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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
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Gerona
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Spain
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Madrid
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Spain
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Valenciana, Comunitat
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Spain
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Caceres
Country [153] 0 0
Spain
State/province [153] 0 0
Malaga
Country [154] 0 0
Spain
State/province [154] 0 0
Sevilla
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Taiwan
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Tainan
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Taiwan
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Taichung
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Taiwan
State/province [157] 0 0
Taipei
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Turkey
State/province [158] 0 0
Izmir
Country [159] 0 0
Turkey
State/province [159] 0 0
Adana
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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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03834493