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This is a study of pembrolizumab (MK-3475) as first-line therapy for participants through progressed gastric or gastroesophageal junction (GEJ) adenocarcinoma. Participants whose tumors expush programmed death-ligand also 1 (PD-L1) will certainly be randomly assigned to among the three therapy arms of the study: pembrolizumab as monotreatment , pembrolizumab plus conventional of treatment (SOC) chemotherapy through cisplatin plus 5-fluorouracil (5-FU) or capecitabine , or placebo plus SOC chemotherapy with cisplatin plus 5-fluorouracil (5-FU) or capecitabine .

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The major research hypotheses are that pembrolizumab in combination via SOC chemotherapy is premium to SOC chemotherapy alone in terms of Progression-totally free Survival (PFS) and Overall Survival (OS) in participants via PD-L1 Incorporated Positive Score (CPS) ≥1, pembrolizumab in combination via SOC chemotherapy is premium to SOC chemotreatment alone in regards to OS in participants with PD-L1 CPS ≥10, pembrolizumab monotreatment is non-inferior to SOC chemotreatment alone in regards to OS in participants via PD-L1 CPS ≥1, and also pembrolizumab monotherapy is exceptional to SOC chemotherapy alone in terms of OS in participants through PD-L1 CPS ≥1 and also in participants through PD-L1 CPS ≥10.


Condition or condition Intervention/therapy Phase
Gastric Adenocarcinoma Biological: Pembrolizumab Drug: Cisplatin Drug: 5-FU Drug: Capecitabine Drug: Placebo Phase 3

As mentioned by the protocol, main and second efficacy analyses will certainly be evaluated in gastric cancer participants with PD-L1 CPS ≥1 (all participants) and also PD-L1 CPS ≥10 (OS) by comparing the pembro mono arm or pembro combo arm independently to the SOC arm.

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Study Type : Interventional (Clinical Trial)
ActualEnrollment : 763 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This research is partially blinded. The participant, examine website personnel, and the sponsor will be blinded in the pembrolizumab plus SOC chemotherapy (pembro combo) arm and the placebo plus SOC chemotreatment (SOC) arm, but not in the pembro monotreatment (mono arm) since just one type of study medication will be administered.
Main Purpose: Treatment
Official Title: A Randomized, Active-Controlled, Partially Blinded, Biomarker Select, Phase III Clinical Trial of Pembrolizumab as Monotreatment and also 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
Actual Study Start Date : July 31, 2015
Actual Key Completion Date : March 26, 2019
Estimated Study Completion Date : June 6, 2022