NCT02370498

A Study of Pembrolizumab (MK-3475) Versus Paclitaxel for Participants With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma That Progressed After Therapy With Platinum and Fluoropyrimidine (MK-3475-061/KEYNOTE-061)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 592 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Adenocarcinoma
• Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	pembrolizumab	200 mg administered as IV infusion on Day 1 of each 21-day cycle.
DRUG	paclitaxel	80 mg/m\^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.

Timeline

• Start date: 2015-05-11
• Primary completion: 2017-10-26
• Completion: 2021-06-10
• First posted: 2015-02-25
• Last updated: 2022-06-06
• Results posted: 2018-11-20

Regulatory

• FDA-regulated drug study