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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03834519




Registration number
NCT03834519
Ethics application status
Date submitted
6/02/2019
Date registered
8/02/2019

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)
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)
Secondary ID [1] 0 0
MK-7339-010
Secondary ID [2] 0 0
7339-010
Universal Trial Number (UTN)
Trial acronym
KEYLYNK-010
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 - 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.


Treatment: Other: 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
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 ~31 months
Primary outcome [2] 0 0
Radiographic Progression-Free Survival (rPFS)
Timepoint [2] 0 0
Up to ~31 months
Secondary outcome [1] 0 0
Time to Initiation of the First Subsequent Anticancer Therapy (TFST)
Timepoint [1] 0 0
Up to ~31 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
Up to ~31 months
Secondary outcome [3] 0 0
Duration of Response (DOR)
Timepoint [3] 0 0
Up to ~24 months
Secondary outcome [4] 0 0
Time to Prostate-Specific Antigen (PSA) Progression
Timepoint [4] 0 0
Up to ~31 months
Secondary outcome [5] 0 0
Time to First Symptomatic Skeletal-Related Event (SSRE)
Timepoint [5] 0 0
Up to ~31 months
Secondary outcome [6] 0 0
Time to Radiographic Soft Tissue Progression
Timepoint [6] 0 0
Up to ~31 months
Secondary outcome [7] 0 0
Time to Pain Progression (TTPP)
Timepoint [7] 0 0
Up to ~31 months
Secondary outcome [8] 0 0
Number of Participants Who Experience an Adverse Event (AE)
Timepoint [8] 0 0
Up to ~31 months
Secondary outcome [9] 0 0
Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Timepoint [9] 0 0
Up to ~880 Days

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
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 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

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2024
Sample size
Target
Accrual to date
Final
793
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St. Vincent's Hospital ( Site 0158) - Darlinghurst
Recruitment hospital [2] 0 0
Macquarie University ( Site 0151) - Macquarie University
Recruitment hospital [3] 0 0
Port Macquarie Base Hospital ( Site 0153) - Port Macquarie
Recruitment hospital [4] 0 0
Calvary Mater Newcastle ( Site 0148) - Waratah
Recruitment hospital [5] 0 0
Southern Medical Day Care Centre ( Site 0160) - Wollongong
Recruitment hospital [6] 0 0
Royal Brisbane and Women s Hospital ( Site 0155) - Herston
Recruitment hospital [7] 0 0
John Flynn Hospital & Medical Centre ( Site 0164) - Tugun
Recruitment hospital [8] 0 0
Box Hill Hospital ( Site 0146) - Box Hill
Recruitment hospital [9] 0 0
Peter MacCallum Cancer Centre ( Site 0152) - Melbourne
Recruitment hospital [10] 0 0
Fiona Stanley Hospital ( Site 0162) - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [4] 0 0
2298 - Waratah
Recruitment postcode(s) [5] 0 0
2500 - Wollongong
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4224 - Tugun
Recruitment postcode(s) [8] 0 0
3128 - Box Hill
Recruitment postcode(s) [9] 0 0
3000 - Melbourne
Recruitment postcode(s) [10] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
State/province [2] 0 0
District of Columbia
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United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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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 Mexico
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New York
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North Carolina
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Ohio
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South Carolina
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Utah
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Washington
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Wisconsin
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Argentina
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Buenos Aires
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Argentina
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Caba
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Santa Fe
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Cordoba
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Oberosterreich
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Steiermark
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Austria
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Salzburg
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Wien
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Rio Grande Do Sul
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Santa Catarina
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Sao Paulo
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Nova Scotia
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Ontario
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Quebec
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Chile
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Araucania
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Chile
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Region M. De Santiago
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Bayern
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Rheinland-Pfalz
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Thuringen
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Limerick
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Afula
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Be'er- Ya'akov
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Beer Sheva
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Haifa
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Jerusalem
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Kfar Saba
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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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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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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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Roma
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Italy
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Terni
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Italy
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Trento
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Japan
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Aichi
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Chiba
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Hyogo
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Ishikawa
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Kanagawa
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Nara
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Osaka
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Saitama
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Shizuoka
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Yamaguchi
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Japan
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Fukuoka
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Miyazaki
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Japan
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Nagano
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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
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Jeonranamdo
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Seoul
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Netherlands
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Fryslan
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Gelderland
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Noord-Holland
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Overijssel
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Zuid-Holland
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New Zealand
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Auckland
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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
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Omskaya Oblast
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Russian Federation
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Samarskaya Oblast
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Russian Federation
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Sankt-Peterburg
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Russian Federation
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Tomskaya Oblast
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Spain
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Barcelona
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Spain
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Extremadura
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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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Malaga
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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
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Taipei
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United Kingdom
State/province [122] 0 0
Bristol, City Of
Country [123] 0 0
United Kingdom
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Cambridgeshire
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Devon
Country [125] 0 0
United Kingdom
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England
Country [126] 0 0
United Kingdom
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Staffordshire
Country [127] 0 0
United Kingdom
State/province [127] 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

TypeCitations or Other Details
Journal Antonarakis ES, Park SH, Goh JC, Shin SJ, Lee JL, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT03834519