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
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03834519
Registration number
NCT03834519
Ethics application status
Date submitted
6/02/2019
Date registered
8/02/2019
Date last updated
2/02/2024
Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)
Query!
Scientific title
A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
Query!
Secondary ID [1]
0
0
MK-7339-010
Query!
Secondary ID [2]
0
0
7339-010
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
KEYLYNK-010
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
Other interventions - Pembrolizumab
Treatment: Drugs - Olaparib
Treatment: Drugs - Abiraterone acetate
Treatment: Drugs - Prednisone
Treatment: Drugs - Enzalutamide
Treatment: Drugs - Prednisolone
Experimental: Pembrolizumab + Olaparib - Participants will receive olaparib 600 mg as two 150 mg oral tablets twice daily (BID) continuously until progression PLUS on Day 1 of each 21-day cycle, pembrolizumab 200 mg by intravenous (IV) infusion for up to 35 cycles (approximately 2 years).
Active Comparator: Next-generation Hormonal Agent Monotherapy (NHA) - Participants will receive a single NHA, which will be either abiraterone acetate (participants previously treated with enzalutamide) 1000 mg as two 500 mg or four 250 mg oral tablets once daily (QD) PLUS prednisone or prednisolone 10 mg as one 5 mg tablet BID until progression OR enzalutamide (participants previously treated with abiraterone acetate) 160 mg as four 40 mg oral tablets or capsules OR two 80 mg tablets QD until progression.
Other interventions: Pembrolizumab
IV infusion
Treatment: Drugs: Olaparib
Oral tablets
Treatment: Drugs: Abiraterone acetate
Oral tablets
Treatment: Drugs: Prednisone
Oral tablets
Treatment: Drugs: Enzalutamide
Oral tablets or oral capsules
Treatment: Drugs: Prednisolone
Oral tablets
Query!
Intervention code [1]
0
0
Other interventions
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
Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Query!
Timepoint [1]
0
0
Up to ~31 months
Query!
Primary outcome [2]
0
0
Radiographic Progression-Free Survival (rPFS)
Query!
Assessment method [2]
0
0
rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is 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 or =2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Query!
Timepoint [2]
0
0
Up to ~31 months
Query!
Secondary outcome [1]
0
0
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Query!
Assessment method [1]
0
0
TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Query!
Timepoint [1]
0
0
Up to ~31 months
Query!
Secondary outcome [2]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [2]
0
0
ORR is 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) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.) The percentage of participants who experienced CR or PR as assessed by BICR is presented.
Query!
Timepoint [2]
0
0
Up to ~31 months
Query!
Secondary outcome [3]
0
0
Duration of Response (DOR)
Query!
Assessment method [3]
0
0
DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG-modified RECIST 1.1, PD is 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. The appearance of = 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented.
Query!
Timepoint [3]
0
0
Up to ~24 months
Query!
Secondary outcome [4]
0
0
Time to Prostate-Specific Antigen (PSA) Progression
Query!
Assessment method [4]
0
0
Time to PSA progression is defined as the 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. The nonparametric Kaplan-Meier method was used to estimate the survival curves.
Query!
Timepoint [4]
0
0
Up to ~31 months
Query!
Secondary outcome [5]
0
0
Time to First Symptomatic Skeletal-Related Event (SSRE)
Query!
Assessment method [5]
0
0
SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first:
First 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
Query!
Timepoint [5]
0
0
Up to ~31 months
Query!
Secondary outcome [6]
0
0
Time to Radiographic Soft Tissue Progression
Query!
Assessment method [6]
0
0
Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression per soft tissue rule of PCWG-modified RECIST 1.1. Progression is 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. The appearance of one or more new lesions is also considered progression. Time to radiographic soft tissue progression as assessed by BICR is presented.
Query!
Timepoint [6]
0
0
Up to ~31 months
Query!
Secondary outcome [7]
0
0
Time to Pain Progression (TTPP)
Query!
Assessment method [7]
0
0
TTPP is defined as the time from randomization to pain progression as determined by Item 3 of the Brief Pain Inventory Short Form (BPI-SF) and by the Analgesic Quantification Algorithm (AQA) score.
Pain progression is defined as:
For participants who are asymptomatic at baseline, a =2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain
For participants who are 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 an average worst pain score =4 and no decrease in average opioid use (=1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits.
Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment.
Query!
Timepoint [7]
0
0
Up to ~31 months
Query!
Secondary outcome [8]
0
0
Number of Participants Who Experience an Adverse Event (AE)
Query!
Assessment method [8]
0
0
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented.
Query!
Timepoint [8]
0
0
Up to ~31 months
Query!
Secondary outcome [9]
0
0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Query!
Assessment method [9]
0
0
The number of participants who discontinue study treatment due to an AE are presented.
Query!
Timepoint [9]
0
0
Up to ~880 Days
Query!
Eligibility
Key inclusion criteria
- Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without
small cell histology
- Has prostate cancer progression while receiving androgen deprivation therapy (or post
bilateral orchiectomy) within 6 months before screening
- Has current evidence of metastatic disease documented by bone lesions on bone scan
and/or soft tissue disease shown by computed tomography/magnetic resonance imaging
(CT/MRI)
- Has received prior treatment with abiraterone acetate OR enzalutamide, but not both
- Have disease that progressed during or after treatment with abiraterone acetate
for either metastatic hormone-sensitive prostate cancer (mHSPC) or mCRP or
enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants
with bone progression)
- Participants that received abiraterone acetate for mHSPC may not have received
abiraterone acetate or enzalutamide for mCRPC
- Have received docetaxel chemotherapy regimen for mCRPC and have had progressive
disease during or after treatment with docetaxel
- Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
- If receiving bone resorptive therapy, including but not limited to bisphosphonates or
denosumab, must have been receiving stable doses before randomization
- Must agree to refrain from donating sperm during the intervention period and for at
least the time needed to eliminate each study intervention after the last dose of
study intervention PLUS be abstinent from heterosexual intercourse OR must agree to
use contraception unless confirmed to be azoospermic
- Contraception use by men should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies. If the
contraception requirements in the local label for any of the study interventions is
more stringent than the requirement above, the local label requirements are to be
followed.
- Has provided tumor tissue from a fresh core or excisional biopsy (obtained within 12
months of screening) from soft tissue not previously irradiated. Samples from tumors
progressing at 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 the past 2
years
- Has a history of (noninfectious) pneumonitis requiring steroids, or has current
pneumonitis
- Has known active human immunodeficiency virus (HIV), hepatitis B virus (e.g.,
hepatitis B surface antigen reactive) or hepatitis C virus (HCV) infection (e.g., HCV
RNA [qualitative] is detected)
- Has known active 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 myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features
suggestive of MDS/AML
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has (=Grade 3) hypersensitivity to pembrolizumab and/or any of its excipients
- Has known hypersensitivity to the components or excipients in olaparib, abiraterone
acetate, prednisone or prednisolone, or enzalutamide
- Has symptomatic congestive heart failure (New York Heart Association Class III or IV
heart disease)
- Has received an anticancer monoclonal antibody (mAb) before randomization
- Has received prior treatment with olaparib or any other PARP inhibitor
- Has received prior treatment with apalutamide or darolutamide
- Has received prior treatment with enzalutamide or apalutamide for metastatic
hormone-sensitive prostate cancer
- Has used herbal products that may have hormonal anti-prostate cancer activity and/or
are known to decrease PSA (e.g., saw palmetto) before the date of randomization
- Has received prior treatment with radium or other therapeutic radiopharmaceuticals for
prostate cancer
- Has received prior treatment with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, or
with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g.,
CTLA-4, OX-40, or CD137)
- Is currently receiving either strong or moderate inhibitors of cytochrome P450 [CYP]
(CYP3A4) that cannot be discontinued for the duration of the study
- Has received a previous allogenic bone marrow transplant or double umbilical cord
transplantation (dUCBT) or a solid organ transplant
- Has received a live vaccine within 30 days prior to the date of randomization
- Is currently participating in or has participated in a study of an investigational
agent, or has used an investigational device, within 4 weeks before the date of
randomization
- Has a bone "superscan"
- Is expecting to father children within the projected duration of the study, starting
with the screening visit through 90 days after the last dose of study intervention
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
Open (masking not used)
Query!
Who is / are masked / blinded?
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
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
2/05/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
27/01/2024
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
793
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
St. Vincent's Hospital ( Site 0158) - Darlinghurst
Query!
Recruitment hospital [2]
0
0
Macquarie University ( Site 0151) - Macquarie University
Query!
Recruitment hospital [3]
0
0
Port Macquarie Base Hospital ( Site 0153) - Port Macquarie
Query!
Recruitment hospital [4]
0
0
Calvary Mater Newcastle ( Site 0148) - Waratah
Query!
Recruitment hospital [5]
0
0
Southern Medical Day Care Centre ( Site 0160) - Wollongong
Query!
Recruitment hospital [6]
0
0
Royal Brisbane and Women s Hospital ( Site 0155) - Herston
Query!
Recruitment hospital [7]
0
0
John Flynn Hospital & Medical Centre ( Site 0164) - Tugun
Query!
Recruitment hospital [8]
0
0
Box Hill Hospital ( Site 0146) - Box Hill
Query!
Recruitment hospital [9]
0
0
Peter MacCallum Cancer Centre ( Site 0152) - Melbourne
Query!
Recruitment hospital [10]
0
0
Fiona Stanley Hospital ( Site 0162) - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [2]
0
0
2109 - Macquarie University
Query!
Recruitment postcode(s) [3]
0
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [4]
0
0
2298 - Waratah
Query!
Recruitment postcode(s) [5]
0
0
2500 - Wollongong
Query!
Recruitment postcode(s) [6]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [7]
0
0
4224 - Tugun
Query!
Recruitment postcode(s) [8]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [9]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [10]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
District of Columbia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Georgia
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Illinois
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Louisiana
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Maryland
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Massachusetts
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Montana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nebraska
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 Mexico
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
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
Utah
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
United States of America
Query!
State/province [20]
0
0
Wisconsin
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Buenos Aires
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Caba
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
Santa Fe
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
Cordoba
Query!
Country [25]
0
0
Austria
Query!
State/province [25]
0
0
Oberosterreich
Query!
Country [26]
0
0
Austria
Query!
State/province [26]
0
0
Steiermark
Query!
Country [27]
0
0
Austria
Query!
State/province [27]
0
0
Salzburg
Query!
Country [28]
0
0
Austria
Query!
State/province [28]
0
0
Wien
Query!
Country [29]
0
0
Brazil
Query!
State/province [29]
0
0
Rio Grande Do Sul
Query!
Country [30]
0
0
Brazil
Query!
State/province [30]
0
0
Santa Catarina
Query!
Country [31]
0
0
Brazil
Query!
State/province [31]
0
0
Sao Paulo
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Alberta
Query!
Country [33]
0
0
Canada
Query!
State/province [33]
0
0
British Columbia
Query!
Country [34]
0
0
Canada
Query!
State/province [34]
0
0
Nova Scotia
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Ontario
Query!
Country [36]
0
0
Canada
Query!
State/province [36]
0
0
Quebec
Query!
Country [37]
0
0
Chile
Query!
State/province [37]
0
0
Araucania
Query!
Country [38]
0
0
Chile
Query!
State/province [38]
0
0
Region M. De Santiago
Query!
Country [39]
0
0
France
Query!
State/province [39]
0
0
Aisne
Query!
Country [40]
0
0
France
Query!
State/province [40]
0
0
Alsace
Query!
Country [41]
0
0
France
Query!
State/province [41]
0
0
Auvergne
Query!
Country [42]
0
0
France
Query!
State/province [42]
0
0
Bouches-du-Rhone
Query!
Country [43]
0
0
France
Query!
State/province [43]
0
0
Bretagne
Query!
Country [44]
0
0
France
Query!
State/province [44]
0
0
Doubs
Query!
Country [45]
0
0
France
Query!
State/province [45]
0
0
Gironde
Query!
Country [46]
0
0
France
Query!
State/province [46]
0
0
Haute-Garonne
Query!
Country [47]
0
0
France
Query!
State/province [47]
0
0
Hauts-de-Seine
Query!
Country [48]
0
0
France
Query!
State/province [48]
0
0
Herault
Query!
Country [49]
0
0
France
Query!
State/province [49]
0
0
Loire-Atlantique
Query!
Country [50]
0
0
France
Query!
State/province [50]
0
0
Loiret
Query!
Country [51]
0
0
France
Query!
State/province [51]
0
0
Meurthe-et-Moselle
Query!
Country [52]
0
0
France
Query!
State/province [52]
0
0
Rhone
Query!
Country [53]
0
0
France
Query!
State/province [53]
0
0
Somme
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Val-de-Marne
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Vaucluse
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
Paris
Query!
Country [57]
0
0
Germany
Query!
State/province [57]
0
0
Baden-Wurttemberg
Query!
Country [58]
0
0
Germany
Query!
State/province [58]
0
0
Bayern
Query!
Country [59]
0
0
Germany
Query!
State/province [59]
0
0
Nordrhein-Westfalen
Query!
Country [60]
0
0
Germany
Query!
State/province [60]
0
0
Rheinland-Pfalz
Query!
Country [61]
0
0
Germany
Query!
State/province [61]
0
0
Thuringen
Query!
Country [62]
0
0
Germany
Query!
State/province [62]
0
0
Berlin
Query!
Country [63]
0
0
Ireland
Query!
State/province [63]
0
0
Dublin
Query!
Country [64]
0
0
Ireland
Query!
State/province [64]
0
0
Limerick
Query!
Country [65]
0
0
Israel
Query!
State/province [65]
0
0
Afula
Query!
Country [66]
0
0
Israel
Query!
State/province [66]
0
0
Be'er- Ya'akov
Query!
Country [67]
0
0
Israel
Query!
State/province [67]
0
0
Beer Sheva
Query!
Country [68]
0
0
Israel
Query!
State/province [68]
0
0
Haifa
Query!
Country [69]
0
0
Israel
Query!
State/province [69]
0
0
Jerusalem
Query!
Country [70]
0
0
Israel
Query!
State/province [70]
0
0
Kfar Saba
Query!
Country [71]
0
0
Israel
Query!
State/province [71]
0
0
Petach-Tikwa
Query!
Country [72]
0
0
Israel
Query!
State/province [72]
0
0
Ramat Gan
Query!
Country [73]
0
0
Israel
Query!
State/province [73]
0
0
Tel-Aviv
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Emilia-Romagna
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Lombardia
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Arezzo
Query!
Country [77]
0
0
Italy
Query!
State/province [77]
0
0
Bologna
Query!
Country [78]
0
0
Italy
Query!
State/province [78]
0
0
Catania
Query!
Country [79]
0
0
Italy
Query!
State/province [79]
0
0
Roma
Query!
Country [80]
0
0
Italy
Query!
State/province [80]
0
0
Terni
Query!
Country [81]
0
0
Italy
Query!
State/province [81]
0
0
Trento
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Aichi
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Chiba
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Ehime
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Hyogo
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Ishikawa
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Kanagawa
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Nara
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Osaka
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Saitama
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Shizuoka
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Yamaguchi
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Fukuoka
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Miyazaki
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Nagano
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Nagasaki
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Tokyo
Query!
Country [98]
0
0
Korea, Republic of
Query!
State/province [98]
0
0
Jeonranamdo
Query!
Country [99]
0
0
Korea, Republic of
Query!
State/province [99]
0
0
Kyonggi-do
Query!
Country [100]
0
0
Korea, Republic of
Query!
State/province [100]
0
0
Seoul
Query!
Country [101]
0
0
Netherlands
Query!
State/province [101]
0
0
Fryslan
Query!
Country [102]
0
0
Netherlands
Query!
State/province [102]
0
0
Gelderland
Query!
Country [103]
0
0
Netherlands
Query!
State/province [103]
0
0
Noord-Holland
Query!
Country [104]
0
0
Netherlands
Query!
State/province [104]
0
0
Overijssel
Query!
Country [105]
0
0
Netherlands
Query!
State/province [105]
0
0
Zuid-Holland
Query!
Country [106]
0
0
New Zealand
Query!
State/province [106]
0
0
Auckland
Query!
Country [107]
0
0
Russian Federation
Query!
State/province [107]
0
0
Chelyabinskaya Oblast
Query!
Country [108]
0
0
Russian Federation
Query!
State/province [108]
0
0
Krasnoyarskiy Kray
Query!
Country [109]
0
0
Russian Federation
Query!
State/province [109]
0
0
Moskva
Query!
Country [110]
0
0
Russian Federation
Query!
State/province [110]
0
0
Omskaya Oblast
Query!
Country [111]
0
0
Russian Federation
Query!
State/province [111]
0
0
Samarskaya Oblast
Query!
Country [112]
0
0
Russian Federation
Query!
State/province [112]
0
0
Sankt-Peterburg
Query!
Country [113]
0
0
Russian Federation
Query!
State/province [113]
0
0
Tomskaya Oblast
Query!
Country [114]
0
0
Spain
Query!
State/province [114]
0
0
Barcelona
Query!
Country [115]
0
0
Spain
Query!
State/province [115]
0
0
Extremadura
Query!
Country [116]
0
0
Spain
Query!
State/province [116]
0
0
Gerona
Query!
Country [117]
0
0
Spain
Query!
State/province [117]
0
0
Madrid
Query!
Country [118]
0
0
Spain
Query!
State/province [118]
0
0
Malaga
Query!
Country [119]
0
0
Taiwan
Query!
State/province [119]
0
0
Tainan
Query!
Country [120]
0
0
Taiwan
Query!
State/province [120]
0
0
Taichung
Query!
Country [121]
0
0
Taiwan
Query!
State/province [121]
0
0
Taipei
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
Bristol, City Of
Query!
Country [123]
0
0
United Kingdom
Query!
State/province [123]
0
0
Cambridgeshire
Query!
Country [124]
0
0
United Kingdom
Query!
State/province [124]
0
0
Devon
Query!
Country [125]
0
0
United Kingdom
Query!
State/province [125]
0
0
England
Query!
Country [126]
0
0
United Kingdom
Query!
State/province [126]
0
0
Staffordshire
Query!
Country [127]
0
0
United Kingdom
Query!
State/province [127]
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 the
polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and
pembrolizumab in the treatment of participants with mCRPC who have failed to respond to
either abiraterone acetate or enzalutamide (but not both) and to chemotherapy.
The primary study hypotheses are that the combination of pembrolizumab plus olaparib is
superior to abiraterone acetate or enzalutamide with respect to:
1. Overall Survival (OS) and
2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group
(PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by
blinded independent central review (BICR)
As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants
still on treatment may have the option to continue receiving study intervention or SOC if
they are deriving clinical benefit, until criteria for discontinuation are met. Participants
who are still on study treatment and deriving clinical benefit will no longer have tumor
response assessments by BICR. However, local tumor imaging assessments should continue per
SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples
will no longer be collected.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03834519
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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03834519
Download to PDF