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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03189719




Registration number
NCT03189719
Ethics application status
Date submitted
14/06/2017
Date registered
16/06/2017

Titles & IDs
Public title
First-line Esophageal Carcinoma Study With Pembrolizumab Plus Chemo vs. Chemo (MK-3475-590/KEYNOTE-590)
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Pembrolizumab (MK-3475) in Combination With Cisplatin and 5-Fluorouracil Versus Placebo in Combination With Cisplatin and 5-Fluorouracil as First-Line Treatment in Subjects With Advanced/Metastatic Esophageal Carcinoma (KEYNOTE-590)
Secondary ID [1] 0 0
173739
Secondary ID [2] 0 0
3475-590
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Esophageal Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Oesophageal (gullet)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Pembrolizumab
Treatment: Drugs - Placebo
Treatment: Drugs - Cisplatin
Treatment: Drugs - 5-FU

Experimental: Pembrolizumab + SOC - Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.

Placebo comparator: Placebo + SOC - Participants receive placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m\^2 IV Q3W and 5-FU 800 mg/m\^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.


Treatment: Other: Pembrolizumab
200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.

Treatment: Drugs: Placebo
Placebo to pembrolizumab (saline) administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.

Treatment: Drugs: Cisplatin
80 mg/m\^2 administered IV Q3W on Day 1 of each 3-week cycle. Duration of cisplatin treatment will be capped at 6 doses.

Treatment: Drugs: 5-FU
800 mg/m\^2/day (4000 mg/m\^2 total per cycle) administered as continuous IV infusion on Days 1 to 5 (120 hours) of each 3-week cycle, or per local standard for 5-FU administration, up to 35 administrations.
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) in Participants With Esophageal Squamous Cell Carcinoma (ESCC) Whose Tumors Are Programmed Cell Death-Ligand 1 (PD-L1) Biomarker-Positive (Combined Positive Score [CPS] =10)
Timepoint [1] 0 0
Up to approximately 34 months
Primary outcome [2] 0 0
OS in Participants With ESCC
Timepoint [2] 0 0
Up to approximately 34 months
Primary outcome [3] 0 0
OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [3] 0 0
Up to approximately 34 months
Primary outcome [4] 0 0
OS in All Participants
Timepoint [4] 0 0
Up to approximately 34 months
Primary outcome [5] 0 0
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) As Assessed By Investigator in Participants With ESCC
Timepoint [5] 0 0
Up to approximately 34 months
Primary outcome [6] 0 0
PFS Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [6] 0 0
Up to approximately 34 months
Primary outcome [7] 0 0
PFS Per RECIST 1.1 As Assessed By Investigator in All Participants
Timepoint [7] 0 0
Up to approximately 34 months
Secondary outcome [1] 0 0
Objective Response Rate (ORR) Per RECIST 1.1 As Assessed By Investigator in All Participants
Timepoint [1] 0 0
Up to approximately 34 months
Secondary outcome [2] 0 0
ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [2] 0 0
Up to approximately 34 months
Secondary outcome [3] 0 0
ORR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC
Timepoint [3] 0 0
Up to approximately 34 months
Secondary outcome [4] 0 0
ORR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [4] 0 0
Up to approximately 34 months
Secondary outcome [5] 0 0
Duration of Response (DOR) Per RECIST 1.1 As Assessed By Investigator in All Participants
Timepoint [5] 0 0
Up to approximately 34 months
Secondary outcome [6] 0 0
DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [6] 0 0
Up to approximately 34 months
Secondary outcome [7] 0 0
DOR Per RECIST 1.1 As Assessed By Investigator in Participants With ESCC
Timepoint [7] 0 0
Up to approximately 34 months
Secondary outcome [8] 0 0
DOR Per RECIST 1.1 As Assessed By Investigator in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [8] 0 0
Up to approximately 34 months
Secondary outcome [9] 0 0
Number of Participants With an Adverse Event (AE)
Timepoint [9] 0 0
Up to approximately 28 months
Secondary outcome [10] 0 0
Number of Participants Discontinuing Study Treatment Due to an AE
Timepoint [10] 0 0
Up to approximately 27 months
Secondary outcome [11] 0 0
Change From Baseline To Week 18 in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Combined Score in All Participants
Timepoint [11] 0 0
Baseline, Week 18
Secondary outcome [12] 0 0
Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [12] 0 0
Baseline, Week 18
Secondary outcome [13] 0 0
Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC
Timepoint [13] 0 0
Baseline, Week 18
Secondary outcome [14] 0 0
Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [14] 0 0
Baseline, Week 18
Secondary outcome [15] 0 0
Change From Baseline in the EORTC Quality Of Life Questionnaire Oesophageal Module (QLQ-OES18) Subscale Scores in All Participants
Timepoint [15] 0 0
Baseline, Week 18
Secondary outcome [16] 0 0
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [16] 0 0
Baseline, Week 18
Secondary outcome [17] 0 0
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants With ESCC
Timepoint [17] 0 0
Baseline, Week 18
Secondary outcome [18] 0 0
Change From Baseline in the EORTC QLQ-OES18 Subscale Scores in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS =10)
Timepoint [18] 0 0
Baseline, Week 18

Eligibility
Key inclusion criteria
* Has histologically- or cytologically-confirmed diagnosis of locally advanced unresectable or metastatic adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the esophagogastric junction (EGJ)
* Has measurable disease per RECIST 1.1 as determined by the local site investigator/radiology assessment
* Eastern Cooperative Group (ECOG) performance status of 0 to 1
* Can provide either a newly obtained or archival tissue sample for PD-L1 by immunohistochemistry analysis
* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to randomization and be willing to use an adequate method of contraception (e.g. abstinence, intrauterine device, diaphragm with spermicide, etc.) for the course of the study through 120 days after the last dose of study treatment and up to 180 days after last dose of cisplatin
* Male participants of childbearing potential must agree to use an adequate method of contraception (e.g. abstinence, vasectomy, male condom, etc.) starting with the first dose of study treatment through 120 days after the last dose of study treatment and up to 180 days after last dose of cisplatin, and refrain from donating sperm during this period
* Has adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has locally advanced esophageal carcinoma that is resectable or potentially curable with radiation therapy (as determined by local investigator)
* Has had previous therapy for advanced/metastatic adenocarcinoma or squamous cell cancer of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the EGJ
* Has had major surgery, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of the need for major surgery during the course of study treatment
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ breast cancer that has undergone potentially curative therapy, and in situ or intramucosal pharyngeal cancer
* Has known active central nervous system metastases and/or carcinomatous meningitis.
* 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 (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment, or has a history of organ transplant, including allogeneic stem cell transplant
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis, or has an active infection requiring systemic therapy
* Is pregnant or breastfeeding, or 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 medication and up to 180 days after last dose of cisplatin
* Has received prior therapy with an anti-programmed cell death protein-1 (anti-PD-1), anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a pembrolizumab (MK-3475) clinical trial
* Has severe hypersensitivity (= Grade 3) to any study treatment (pembrolizumab, cisplatin, or 5-FU) and/or any of its excipients
* Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis) or human immunodeficiency virus (HIV) infection
* Has known history of or is positive for hepatitis B or hepatitis C
* Has received a live vaccine within 30 days prior to the first dose of study treatment
* Has had radiotherapy within 14 days of randomization. Participants who received radiotherapy >14 days prior to randomization must have completely recovered from any radiotherapy-related AEs/toxicities

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 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
25/07/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
10/07/2023
Sample size
Target
Accrual to date
Final
749
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital ( Site 2000) - Blacktown
Recruitment hospital [2] 0 0
Liverpool Hospital. ( Site 2001) - Liverpool
Recruitment hospital [3] 0 0
Princess Alexandra Hospital ( Site 2005) - Woolloongabba
Recruitment hospital [4] 0 0
Eastern Health ( Site 2002) - Box Hill
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre ( Site 2003) - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Ohio
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
Argentina
State/province [12] 0 0
Rio Negro
Country [13] 0 0
Argentina
State/province [13] 0 0
Buenos Aires
Country [14] 0 0
Argentina
State/province [14] 0 0
Cordoba
Country [15] 0 0
Brazil
State/province [15] 0 0
Minas Gerais
Country [16] 0 0
Brazil
State/province [16] 0 0
Pernambuco
Country [17] 0 0
Brazil
State/province [17] 0 0
Rio Grande Do Sul
Country [18] 0 0
Brazil
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RJ
Country [19] 0 0
Brazil
State/province [19] 0 0
RS
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Brazil
State/province [20] 0 0
Sao Paulo
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Brazil
State/province [21] 0 0
SP
Country [22] 0 0
Brazil
State/province [22] 0 0
Porto Alegre
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Manitoba
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec
Country [27] 0 0
Chile
State/province [27] 0 0
Concepcion
Country [28] 0 0
Chile
State/province [28] 0 0
Santiago
Country [29] 0 0
Chile
State/province [29] 0 0
Temuco
Country [30] 0 0
China
State/province [30] 0 0
Anhui
Country [31] 0 0
China
State/province [31] 0 0
Beijing
Country [32] 0 0
China
State/province [32] 0 0
Fujian
Country [33] 0 0
China
State/province [33] 0 0
Guangdong
Country [34] 0 0
China
State/province [34] 0 0
Heilongjiang
Country [35] 0 0
China
State/province [35] 0 0
Hubei
Country [36] 0 0
China
State/province [36] 0 0
Hunan
Country [37] 0 0
China
State/province [37] 0 0
Jiangsu
Country [38] 0 0
China
State/province [38] 0 0
Jilin
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China
State/province [39] 0 0
Shannxi
Country [40] 0 0
China
State/province [40] 0 0
Zhejiang
Country [41] 0 0
China
State/province [41] 0 0
Fuzhou
Country [42] 0 0
China
State/province [42] 0 0
Shanghai
Country [43] 0 0
China
State/province [43] 0 0
Zhengzhou
Country [44] 0 0
Colombia
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Antioquia
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Colombia
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Cordoba
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Costa Rica
State/province [46] 0 0
San Jose
Country [47] 0 0
Denmark
State/province [47] 0 0
Copenhagen
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Denmark
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Odense
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France
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Cedex 8
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France
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Brest
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France
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Caen
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France
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Lille
Country [53] 0 0
France
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Montpellier
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France
State/province [54] 0 0
Nantes Cedex 1
Country [55] 0 0
France
State/province [55] 0 0
Paris
Country [56] 0 0
France
State/province [56] 0 0
Saint Etienne
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Germany
State/province [57] 0 0
Dresden
Country [58] 0 0
Germany
State/province [58] 0 0
Hamburg
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Germany
State/province [59] 0 0
Leipzig
Country [60] 0 0
Germany
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Ludwigsburg
Country [61] 0 0
Germany
State/province [61] 0 0
Mannheim
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Germany
State/province [62] 0 0
Moenchengladbach
Country [63] 0 0
Germany
State/province [63] 0 0
Munchen
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Guatemala
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Guatemala
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Guatemala
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Quetzaltenango
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Hong Kong
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Hong Kong
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Japan
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Aichi
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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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Hokkaido
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Japan
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Hyogo
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Japan
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Ibaraki
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Japan
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Kagawa
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Japan
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Kanagawa
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Japan
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Oita
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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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Tokyo
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Kumamoto
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Japan
State/province [83] 0 0
Niigata
Country [84] 0 0
Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
State/province [85] 0 0
Jeollanam Do
Country [86] 0 0
Korea, Republic of
State/province [86] 0 0
Seoul
Country [87] 0 0
Malaysia
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Selangor
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Malaysia
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Kuala Lumpur
Country [89] 0 0
Peru
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Arequipa
Country [90] 0 0
Peru
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Lima
Country [91] 0 0
Romania
State/province [91] 0 0
Bihor
Country [92] 0 0
Romania
State/province [92] 0 0
Cluj
Country [93] 0 0
Romania
State/province [93] 0 0
Dolj
Country [94] 0 0
Romania
State/province [94] 0 0
Sector 2
Country [95] 0 0
Romania
State/province [95] 0 0
Timis
Country [96] 0 0
Romania
State/province [96] 0 0
Bucuresti
Country [97] 0 0
Romania
State/province [97] 0 0
Constanta
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Republic Of Bashkortostan
Country [99] 0 0
Russian Federation
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Vsevolzhsk District
Country [100] 0 0
Russian Federation
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Moscow
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Russian Federation
State/province [101] 0 0
Saint-Petersburg
Country [102] 0 0
Russian Federation
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St. Petersburg
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Russian Federation
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Tomsk
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South Africa
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Eastern Cape
Country [105] 0 0
South Africa
State/province [105] 0 0
Gauteng
Country [106] 0 0
South Africa
State/province [106] 0 0
Kwa-Zulu Natal
Country [107] 0 0
South Africa
State/province [107] 0 0
Western Cape
Country [108] 0 0
South Africa
State/province [108] 0 0
Alberton
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Cordoba
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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
State/province [114] 0 0
Kaohsiung
Country [115] 0 0
Taiwan
State/province [115] 0 0
New Taipei
Country [116] 0 0
Taiwan
State/province [116] 0 0
Taichung
Country [117] 0 0
Taiwan
State/province [117] 0 0
Tainan
Country [118] 0 0
Taiwan
State/province [118] 0 0
Taipei
Country [119] 0 0
Taiwan
State/province [119] 0 0
Taoyuan
Country [120] 0 0
Thailand
State/province [120] 0 0
Bangkok
Country [121] 0 0
Thailand
State/province [121] 0 0
Songkla
Country [122] 0 0
Turkey
State/province [122] 0 0
Adana
Country [123] 0 0
Turkey
State/province [123] 0 0
Ankara
Country [124] 0 0
Turkey
State/province [124] 0 0
Istanbul
Country [125] 0 0
Turkey
State/province [125] 0 0
Izmir
Country [126] 0 0
Turkey
State/province [126] 0 0
Malatya
Country [127] 0 0
United Kingdom
State/province [127] 0 0
Mid Lothian
Country [128] 0 0
United Kingdom
State/province [128] 0 0
Guildford
Country [129] 0 0
United Kingdom
State/province [129] 0 0
Manchester

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/NCT03189719