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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	29 August 2022
Main ID:	NCT02494583
Date of registration:	08/07/2015
Prospective Registration:	Yes
Primary sponsor:	Merck Sharp & Dohme LLC
Public title:	Study of Pembrolizumab (MK-3475) as First-Line Monotherapy and Combination Therapy for Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (MK-3475-062/KEYNOTE-062)
Scientific title:	A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil Versus Placebo+Cisplatin+5-Fluorouracil as First-Line Treatment in Subjects With Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma
Date of first enrolment:	July 31, 2015
Target sample size:	763
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02494583
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 3

Countries of recruitment
Argentina	Australia	Austria	Belgium	Brazil	Chile	Colombia	Czech Republic
Czechia	Germany	Guatemala	Hong Kong	Hungary	Italy	Japan	Korea, Republic of
Latvia	Lithuania	Mexico	Netherlands	New Zealand	Poland	Puerto Rico	Russian Federation
South Africa	Spain	Switzerland	Taiwan	United Kingdom	United States

Contacts

Name:	Medical Director
Address:
Telephone:
Email:
Affiliation:	Merck Sharp & Dohme LLC

Key inclusion & exclusion criteria

Health Condition(s) or Problem(s) studied

Intervention(s)

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	13/03/2020
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT02494583

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