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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03834506




Registration number
NCT03834506
Ethics application status
Date submitted
6/02/2019
Date registered
8/02/2019

Titles & IDs
Public title
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)
Scientific title
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
Secondary ID [1] 0 0
MK-3475-921
Secondary ID [2] 0 0
3475-921
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 - Docetaxel
Treatment: Drugs - Prednisone
Treatment: Drugs - Placebo
Treatment: Drugs - Dexamethasone

Experimental: Pembrolizumab+Docetaxel - Participants receive pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.

Placebo comparator: Placebo+Docetaxel - Participants receive placebo by IV infusion on Day 1 of each 21-day cycle (Q3W) for up to a maximum of 35 cycles (approximately 2 years) PLUS docetaxel 75 mg/m\^2 by IV infusion on Day 1 of each 21-day cycle (Q3W) for a maximum of 10 cycles (approximately 7 months). Participants also concomitantly receive dexamethasone 8 mg by oral tablets at 12 hours, 3 hours, and 1 hour prior to docetaxel administration and prednisone 5 mg by oral tablets twice daily during each 21-day docetaxel cycle.


Treatment: Other: Pembrolizumab
IV infusion

Treatment: Drugs: Docetaxel
IV infusion

Treatment: Drugs: Prednisone
Oral tablets

Treatment: Drugs: Placebo
IV infusion

Treatment: Drugs: Dexamethasone
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 36.5 months
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 (BICR)
Timepoint [2] 0 0
Up to approximately 28 months
Secondary outcome [1] 0 0
Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST)
Timepoint [1] 0 0
Up to approximately 28 months
Secondary outcome [2] 0 0
Prostate-specific Antigen (PSA) Response Rate
Timepoint [2] 0 0
Up to 36.5 months
Secondary outcome [3] 0 0
Objective Response Rate (ORR) 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)
Timepoint [3] 0 0
Up to 36.5 months
Secondary outcome [4] 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) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [4] 0 0
Up to 36.5 months
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 Analgesic Use Assessed by the Analgesic Quantification Algorithm (AQA) Score
Timepoint [5] 0 0
Up to 36.5 months
Secondary outcome [6] 0 0
Time to First Symptomatic Skeletal-related Event (SSRE)
Timepoint [6] 0 0
Up to 36.5 months
Secondary outcome [7] 0 0
Time to Prostate-specific Antigen (PSA) Progression
Timepoint [7] 0 0
Up to 36.5 months
Secondary outcome [8] 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) as Assessed by Blinded Independent Central Review (BICR)
Timepoint [8] 0 0
Up to 36.5 months
Secondary outcome [9] 0 0
Number of Participants Who Experienced an Adverse Event (AE)
Timepoint [9] 0 0
Up to approximately 30 months
Secondary outcome [10] 0 0
Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE)
Timepoint [10] 0 0
Up to approximately 27 months

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 screening
* 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 received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug
* 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 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
* Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex
* 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 (non-infectious) pneumonitis that required steroids or current pneumonitis
* Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients
* Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
* Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade =1 or at baseline) from AEs due to mAbs
* Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization
* Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
* 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 co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
* Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC
* Has hypersensitivity to docetaxel or polysorbate 80
* Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study
* Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade =1 or at baseline) from AEs due to a previously administered agent
* Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis
* Has received a live vaccine within 30 days prior to randomization
* Has received treatment with 5a reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization
* Has received prior treatment with ketoconazole for prostate cancer
* 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 120 days after the last dose of study treatment
* 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
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
18/07/2023
Sample size
Target
Accrual to date
Final
1030
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
St George Hospital ( Site 0157) - Kogarah
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
Redcliffe Hospital ( Site 0161) - Redcliffe
Recruitment hospital [6] 0 0
John Flynn Hospital & Medical Centre ( Site 0164) - Tugun
Recruitment hospital [7] 0 0
Hollywood Private Hospital ( Site 0163) - Nedlands
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
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
4020 - Redcliffe
Recruitment postcode(s) [6] 0 0
4224 - Tugun
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
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
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Montana
Country [12] 0 0
United States of America
State/province [12] 0 0
Nebraska
Country [13] 0 0
United States of America
State/province [13] 0 0
Nevada
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
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North Carolina
Country [17] 0 0
United States of America
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Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Oregon
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
Argentina
State/province [21] 0 0
Buenos Aires
Country [22] 0 0
Argentina
State/province [22] 0 0
Caba
Country [23] 0 0
Argentina
State/province [23] 0 0
Santa Fe
Country [24] 0 0
Argentina
State/province [24] 0 0
Cordoba
Country [25] 0 0
Austria
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Oberosterreich
Country [26] 0 0
Austria
State/province [26] 0 0
Steiermark
Country [27] 0 0
Austria
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Salzburg
Country [28] 0 0
Austria
State/province [28] 0 0
Wien
Country [29] 0 0
Brazil
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Rio Grande Do Sul
Country [30] 0 0
Brazil
State/province [30] 0 0
Santa Catarina
Country [31] 0 0
Brazil
State/province [31] 0 0
Sao Paulo
Country [32] 0 0
Canada
State/province [32] 0 0
Nova Scotia
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Chile
State/province [35] 0 0
Araucania
Country [36] 0 0
Chile
State/province [36] 0 0
Region M. De Santiago
Country [37] 0 0
Chile
State/province [37] 0 0
Valparaiso
Country [38] 0 0
China
State/province [38] 0 0
Beijing
Country [39] 0 0
China
State/province [39] 0 0
Fujian
Country [40] 0 0
China
State/province [40] 0 0
Guangdong
Country [41] 0 0
China
State/province [41] 0 0
Heilongjiang
Country [42] 0 0
China
State/province [42] 0 0
Henan
Country [43] 0 0
China
State/province [43] 0 0
Hubei
Country [44] 0 0
China
State/province [44] 0 0
Hunan
Country [45] 0 0
China
State/province [45] 0 0
Jiangsu
Country [46] 0 0
China
State/province [46] 0 0
Shanghai
Country [47] 0 0
China
State/province [47] 0 0
Zhejiang
Country [48] 0 0
Colombia
State/province [48] 0 0
Antioquia
Country [49] 0 0
Colombia
State/province [49] 0 0
Atlantico
Country [50] 0 0
Colombia
State/province [50] 0 0
Cesar
Country [51] 0 0
Colombia
State/province [51] 0 0
Cordoba
Country [52] 0 0
Colombia
State/province [52] 0 0
Distrito Capital De Bogota
Country [53] 0 0
Colombia
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Risaralda
Country [54] 0 0
Colombia
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Valle Del Cauca
Country [55] 0 0
France
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Aisne
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France
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Alsace
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France
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Auvergne
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France
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Bouches-du-Rhone
Country [59] 0 0
France
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Doubs
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France
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Finistere
Country [61] 0 0
France
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Gironde
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France
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Haute-Garonne
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France
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Hauts-de-Seine
Country [64] 0 0
France
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Loire-Atlantique
Country [65] 0 0
France
State/province [65] 0 0
Loiret
Country [66] 0 0
France
State/province [66] 0 0
Meurthe-et-Moselle
Country [67] 0 0
France
State/province [67] 0 0
Rhone
Country [68] 0 0
France
State/province [68] 0 0
Somme
Country [69] 0 0
France
State/province [69] 0 0
Val-de-Marne
Country [70] 0 0
France
State/province [70] 0 0
Vaucluse
Country [71] 0 0
France
State/province [71] 0 0
Paris
Country [72] 0 0
Germany
State/province [72] 0 0
Baden-Wurttemberg
Country [73] 0 0
Germany
State/province [73] 0 0
Bayern
Country [74] 0 0
Germany
State/province [74] 0 0
Niedersachsen
Country [75] 0 0
Germany
State/province [75] 0 0
Nordrhein-Westfalen
Country [76] 0 0
Germany
State/province [76] 0 0
Saarland
Country [77] 0 0
Germany
State/province [77] 0 0
Thuringen
Country [78] 0 0
Germany
State/province [78] 0 0
Berlin
Country [79] 0 0
Ireland
State/province [79] 0 0
Cork
Country [80] 0 0
Ireland
State/province [80] 0 0
Dublin
Country [81] 0 0
Ireland
State/province [81] 0 0
Limerick
Country [82] 0 0
Israel
State/province [82] 0 0
Beer Sheva
Country [83] 0 0
Israel
State/province [83] 0 0
Beer Yaakov-Zerifin
Country [84] 0 0
Israel
State/province [84] 0 0
Haifa
Country [85] 0 0
Israel
State/province [85] 0 0
Jerusalem
Country [86] 0 0
Israel
State/province [86] 0 0
Kfar Saba
Country [87] 0 0
Israel
State/province [87] 0 0
Petach-Tikwa
Country [88] 0 0
Israel
State/province [88] 0 0
Ramat Gan
Country [89] 0 0
Israel
State/province [89] 0 0
Tel Aviv
Country [90] 0 0
Italy
State/province [90] 0 0
Milano
Country [91] 0 0
Italy
State/province [91] 0 0
Catania
Country [92] 0 0
Italy
State/province [92] 0 0
Modena
Country [93] 0 0
Italy
State/province [93] 0 0
Napoli
Country [94] 0 0
Italy
State/province [94] 0 0
Roma
Country [95] 0 0
Italy
State/province [95] 0 0
Terni
Country [96] 0 0
Italy
State/province [96] 0 0
Trento
Country [97] 0 0
Japan
State/province [97] 0 0
Chiba
Country [98] 0 0
Japan
State/province [98] 0 0
Ehime
Country [99] 0 0
Japan
State/province [99] 0 0
Ishikawa
Country [100] 0 0
Japan
State/province [100] 0 0
Kanagawa
Country [101] 0 0
Japan
State/province [101] 0 0
Nara
Country [102] 0 0
Japan
State/province [102] 0 0
Osaka
Country [103] 0 0
Japan
State/province [103] 0 0
Saitama
Country [104] 0 0
Japan
State/province [104] 0 0
Shizuoka
Country [105] 0 0
Japan
State/province [105] 0 0
Yamaguchi
Country [106] 0 0
Japan
State/province [106] 0 0
Fukuoka
Country [107] 0 0
Japan
State/province [107] 0 0
Miyazaki
Country [108] 0 0
Japan
State/province [108] 0 0
Nagasaki
Country [109] 0 0
Japan
State/province [109] 0 0
Tokyo
Country [110] 0 0
Korea, Republic of
State/province [110] 0 0
Kyonggi-do
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Seoul
Country [112] 0 0
Netherlands
State/province [112] 0 0
Fryslan
Country [113] 0 0
Netherlands
State/province [113] 0 0
Gelderland
Country [114] 0 0
Netherlands
State/province [114] 0 0
Limburg
Country [115] 0 0
Netherlands
State/province [115] 0 0
Noord-Brabant
Country [116] 0 0
Netherlands
State/province [116] 0 0
Noord-Holland
Country [117] 0 0
Netherlands
State/province [117] 0 0
Overijssel
Country [118] 0 0
Netherlands
State/province [118] 0 0
Zuid-Holland
Country [119] 0 0
Russian Federation
State/province [119] 0 0
Chelyabinskaya Oblast
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Krasnoyarskiy Kray
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Moskva
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Nizhegorodskaya Oblast
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Omskaya Oblast
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Samarskaya Oblast
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Sankt-Peterburg
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Tomskaya Oblast
Country [127] 0 0
Spain
State/province [127] 0 0
Barcelona
Country [128] 0 0
Spain
State/province [128] 0 0
Cantabria
Country [129] 0 0
Spain
State/province [129] 0 0
Gerona
Country [130] 0 0
Spain
State/province [130] 0 0
Madrid
Country [131] 0 0
Spain
State/province [131] 0 0
Malaga
Country [132] 0 0
Spain
State/province [132] 0 0
Sevilla
Country [133] 0 0
Taiwan
State/province [133] 0 0
Tainan
Country [134] 0 0
Taiwan
State/province [134] 0 0
Taichung
Country [135] 0 0
Taiwan
State/province [135] 0 0
Taipei
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Bristol, City Of
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Cambridgeshire
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Devon
Country [139] 0 0
United Kingdom
State/province [139] 0 0
England
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Hertfordshire
Country [141] 0 0
United Kingdom
State/province [141] 0 0
London, City Of
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Staffordshire

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 not provided in https://clinicaltrials.gov/study/NCT03834506