At a glance
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A Phase III, Randomized, Open-label Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel in Subjects With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma Who Progressed After First-Line Therapy With Platinum and Fluoropyrimidine
In Brief
A Phase 3 clinical trial evaluating pembrolizumab and paclitaxel for Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma. Completed, enrolled 592 participants.
Detailed Summary
This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who have had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The primary study hypotheses are that pembrolizumab (MK-3475) prolongs progression free survival (PFS) and overall survival (OS) for participants with tumors that show positive programmed cell death ligand 1 (PD-L1) expression. As of 20-March-2016, enrollment will be limited to PD-L1 positive participants.
Study Details
Timeline
Interventions
200 mg administered as IV infusion on Day 1 of each 21-day cycle.
80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.