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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)
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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
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Secondary ID [1]
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MK-3475-966
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Secondary ID [2]
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3475-966
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Universal Trial Number (UTN)
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Trial acronym
KEYNOTE-966
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Biliary Tract Carcinoma
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Condition category
Condition code
Cancer
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Non melanoma skin cancer
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Cancer
0
0
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0
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Kidney
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival was defined as the time from randomization to death due to any cause.
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Timepoint [1]
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Up to approximately 38 months
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Secondary outcome [1]
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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)
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Assessment method [1]
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PFS was defined as the time from randomization to the first documented progressive disease (PD) per RECIST 1.1 by BICR, or death due to any cause, whichever occurred first.
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Timepoint [1]
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Up to approximately 26 months
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Secondary outcome [2]
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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)
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Assessment method [2]
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ORR was defined as the percentage of participants who have a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: a =30% decrease in the sum of diameters \[SOD\] of target lesions) as assessed by BICR per RECIST 1.1, which was adjusted for this study to allow a maximum of 10 target lesions in total and 5 per organ.
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Timepoint [2]
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Up to approximately 26 months
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Secondary outcome [3]
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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR
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Assessment method [3]
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For participants who demonstrate a confirmed CR or PR, DOR was the time from the first documented evidence of CR or PR until disease progression or death due to any cause, whichever occurred first.
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Timepoint [3]
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Up to approximately 38 months
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Secondary outcome [4]
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Number of Participants Who Experience One or More Adverse Events (AE)
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Assessment method [4]
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An adverse event (AE) was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
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Timepoint [4]
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Up to approximately 38 months
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Secondary outcome [5]
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Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
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Assessment method [5]
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An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurs during the course of the study.
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Timepoint [5]
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Up to approximately 38 months
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
24/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
29/11/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1069
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Liverpool Hospital ( Site 0707) - Liverpool
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Mid North Coast Cancer Institute ( Site 0708) - Port Macquarie
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Gallipoli Medical Research Foundation ( Site 0705) - Brisbane
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Eastern Health ( Site 0704) - Box Hill
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Western Health-Sunshine Hospital ( Site 0709) - St Albans
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2170 - Liverpool
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2444 - Port Macquarie
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4120 - Brisbane
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3128 - Box Hill
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3021 - St Albans
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Adana
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Country [116]
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0
Turkey
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State/province [116]
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Ankara
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Country [117]
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0
Turkey
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State/province [117]
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Istanbul
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Country [118]
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0
Turkey
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State/province [118]
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Izmir
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Country [119]
0
0
Turkey
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State/province [119]
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Kayseri
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Country [120]
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United Kingdom
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State/province [120]
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Aberdeen City
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Country [121]
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United Kingdom
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State/province [121]
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London, City Of
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Country [122]
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United Kingdom
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State/province [122]
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Surrey
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Country [123]
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United Kingdom
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State/province [123]
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Belfast
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Country [124]
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United Kingdom
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State/province [124]
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Coventry
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Country [125]
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United Kingdom
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State/province [125]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a 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. The primary hypothesis is pembrolizumab plus gemcitabine/cisplatin is superior to placebo plus gemcitabine/cisplatin with respect to overall survival (OS).
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Trial website
https://clinicaltrials.gov/study/NCT04003636
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Trial related presentations / publications
Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z, Yau T, Klumpen HJ, Chan SL, Ozaka M, Verslype C, Bouattour M, Park JO, Barajas O, Pelzer U, Valle JW, Yu L, Malhotra U, Siegel AB, Edeline J, Vogel A; KEYNOTE-966 Investigators. Pembrolizumab in combination with gemcitabine and cisplatin compared with gemcitabine and cisplatin alone for patients with advanced biliary tract cancer (KEYNOTE-966): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 3;401(10391):1853-1865. doi: 10.1016/S0140-6736(23)00727-4. Epub 2023 Apr 16. Erratum In: Lancet. 2023 Sep 16;402(10406):964. doi: 10.1016/S0140-6736(23)01904-9. Lancet. 2024 Mar 23;403(10432):1140. doi: 10.1016/S0140-6736(24)00545-2.
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Public notes
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Contacts
Principal investigator
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/36/NCT04003636/Prot_SAP_000.pdf
Statistical analysis plan
Study Protocol and Statistical Analysis Plan
https://cdn.clinicaltrials.gov/large-docs/36/NCT04003636/Prot_SAP_000.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Kelley RK, Ueno M, Yoo C, Finn RS, Furuse J, Ren Z...
[
More Details
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Results not provided in
https://clinicaltrials.gov/study/NCT04003636