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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04003636




Registration number
NCT04003636
Ethics application status
Date submitted
28/06/2019
Date registered
1/07/2019

Titles & IDs
Public title
Pembrolizumab (MK-3475) Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin for First-Line Advanced and/or Unresectable Biliary Tract Carcinoma (BTC) (MK-3475-966/KEYNOTE-966)
Scientific title
A Phase 3 Randomized, Double Blind Study of Pembrolizumab Plus Gemcitabine/Cisplatin Versus Placebo Plus Gemcitabine/Cisplatin as First-Line Therapy in Participants With Advanced and/or Unresectable Biliary Tract Carcinoma
Secondary ID [1] 0 0
MK-3475-966
Secondary ID [2] 0 0
3475-966
Universal Trial Number (UTN)
Trial acronym
KEYNOTE-966
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Biliary Tract Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

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

Experimental: Arm A (Pembrolizumab+Gemcitabine+Cisplatin) - Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.

Placebo comparator: Arm B (Placebo+Gemcitabine+Cisplatin) - Placebo to Pembrolizumab, 200 mg, every 3 weeks (Q3W), Day 1 of each 3-week cycle for up to 35 cycles PLUS Gemcitabine, 1000 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle until progressive disease or unacceptable toxicity PLUS Cisplatin, 25 mg/m\^2, Q3W, Day 1 and Day 8 of each cycle for up to 8 cycles.


Treatment: Other: Pembrolizumab
Pembrolizumab by intravenous (IV) infusion

Treatment: Drugs: Gemcitabine
Gemcitabine by IV infusion

Treatment: Drugs: Cisplatin
Cisplatin by IV infusion

Treatment: Drugs: Placebo
Placebo to pembrolizumab
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 approximately 38 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (BICR)
Timepoint [1] 0 0
Up to approximately 26 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) Per 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 26 months
Secondary outcome [3] 0 0
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
Timepoint [3] 0 0
Up to approximately 38 months
Secondary outcome [4] 0 0
Number of Participants Who Experience One or More Adverse Events (AE)
Timepoint [4] 0 0
Up to approximately 38 months
Secondary outcome [5] 0 0
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Timepoint [5] 0 0
Up to approximately 38 months

Eligibility
Key inclusion criteria
Inclusion Criteria

* Has histologically confirmed diagnosis of advanced (metastatic) and/or unresectable (locally advanced) biliary tract cancer (intra-or extrahepatic cholangiocarcinoma or gallbladder cancer)
* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as determined by the site investigator
* Participants with a history of hepatitis B or hepatitis C can be enrolled if they meet study criteria
* Is able to provide archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
* Has a life expectancy of greater than 3 months
* 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
Exclusion Criteria

* Has had previous systemic therapy for advanced (metastatic) or unresectable (locally advanced) biliary tract cancer (intra-or extra hepatic cholangiocarcinoma or gallbladder cancer)
* Has ampullary cancer
* Has small cell cancer, neuroendocrine tumors, lymphoma, sarcoma, mixed tumor histology and/or mucinous cystic neoplasms
* Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti- programmed cell death ligand 1 or 2 (anti-PD-L1, anti-PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis, as assessed by local site investigator
* Has had an allogenic tissue/solid organ transplant

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

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

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
Accrual to date
Final
1069
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital ( Site 0707) - Liverpool
Recruitment hospital [2] 0 0
Mid North Coast Cancer Institute ( Site 0708) - Port Macquarie
Recruitment hospital [3] 0 0
Gallipoli Medical Research Foundation ( Site 0705) - Brisbane
Recruitment hospital [4] 0 0
Eastern Health ( Site 0704) - Box Hill
Recruitment hospital [5] 0 0
Western Health-Sunshine Hospital ( Site 0709) - St Albans
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
4120 - Brisbane
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3021 - St Albans
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Connecticut
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Georgia
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United States of America
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Illinois
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United States of America
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New York
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United States of America
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Oklahoma
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United States of America
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Oregon
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United States of America
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South Carolina
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United States of America
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Virginia
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Argentina
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Caba
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Argentina
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Tucuman
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Argentina
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La Rioja
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Belgium
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Antwerpen
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Belgium
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Bruxelles-Capitale, Region De
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Belgium
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Hainaut
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Belgium
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Liege
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Belgium
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Oost-Vlaanderen
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Belgium
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Vlaams-Brabant
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Brazil
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Minas Gerais
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Brazil
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Rio Grande Do Sul
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Brazil
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Rio de Janeiro
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Brazil
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Sao Paulo
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Coquimbo
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Chile
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Lbtdr Gen Bernardo O Higgins
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Chile
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Region M. De Santiago
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China
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Anhui
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China
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Beijing
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China
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Chongqing
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China
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Fujian
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China
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Guangdong
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China
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Hainan
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Heilongjiang
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China
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Hunan
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Jiangsu
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Jilin
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Shanghai
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China
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Shanxi
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China
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Sichuan
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China
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Tianjin
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China
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Zhejiang
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France
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Gironde
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France
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Hauts-de-Seine
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France
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Herault
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France
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Ille-et-Vilaine
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France
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Puy-de-Dome
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France
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Val-de-Marne
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Germany
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Baden-Wurttemberg
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Germany
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Sachsen
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Germany
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Berlin
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Germany
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Hamburg
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Hong Kong
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Hong Kong
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Hong Kong
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Kowloon
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Ireland
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Cork
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Dublin
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Israel
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Haifa
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Israel
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Jerusalem
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Israel
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Petah Tikva
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Israel
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Tel Aviv
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Abruzzo
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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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Milano
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Italy
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Pisa
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Italy
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Roma
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Italy
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Verona
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Japan
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Aichi
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Chiba
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Hyogo
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Kagawa
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Japan
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Kanagawa
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Japan
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Osaka
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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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Kyoto
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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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Taegu-Kwangyokshi
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Korea, Republic of
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Taejon-Kwangyokshi
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Korea, Republic of
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Seoul
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Malaysia
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Johor
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Malaysia
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Kuala Lumpur
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Malaysia
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Pulau Pinang
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Malaysia
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Wilayah Persekutuan Putrajaya
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Netherlands
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Limburg
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Noord-Holland
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Zuid-Holland
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Groningen
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Utrecht
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New Zealand
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Auckland
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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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Madrid
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Spain
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Malaga
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Taiwan
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Taipei
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taoyuan
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Thailand
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Krung Thep Maha Nakhon
Country [111] 0 0
Thailand
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Ubon Ratchathani
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Udon Thani
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Turkey
State/province [115] 0 0
Adana
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Turkey
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Ankara
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Turkey
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Istanbul
Country [118] 0 0
Turkey
State/province [118] 0 0
Izmir
Country [119] 0 0
Turkey
State/province [119] 0 0
Kayseri
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Aberdeen City
Country [121] 0 0
United Kingdom
State/province [121] 0 0
London, City Of
Country [122] 0 0
United Kingdom
State/province [122] 0 0
Surrey
Country [123] 0 0
United Kingdom
State/province [123] 0 0
Belfast
Country [124] 0 0
United Kingdom
State/province [124] 0 0
Coventry
Country [125] 0 0
United Kingdom
State/province [125] 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

TypeCitations or Other Details
Journal Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT04003636