CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 318 enrolled
Drug / intervention
pembrolizumab +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02335411
NCT02335411Phase 2Completed

A Phase II Clinical Trial of Pembrolizumab as Monotherapy and in Combination With Cisplatin+5-Fluorouracil in Subjects With Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (KEYNOTE-059)

Merck Sharp & Dohme LLC·interventional·Posted Jan 9, 2015·Updated Aug 8, 2022

In Brief

A Phase 2 clinical trial evaluating pembrolizumab, cisplatin, and 2 other interventions for Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma. Completed, enrolled 318 participants.

Detailed Summary

This is a study of pembrolizumab (MK-3475) for advanced gastric or gastroesophageal junction adenocarcinoma; pembrolizumab will be given as monotherapy to participants who have had previous treatment or who are treatment-naïve; pembrolizumab will also be evaluated as combination therapy with cisplatin and 5-Fluorouracil (5-FU) or (Japan only) capecitabine in treatment-naïve participants. The primary study hypothesis is that pembrolizumab will provide a clinically meaningful Overall Response Rate (ORR).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 9, 2015
Enrollment StartFeb 3, 2015
Primary CompletionJul 23, 2021
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 11.5 years ago

Interventions

pembrolizumabbiological

IV infusion

cisplatindrug

IV infusion

5-FUdrug

IV infusion

capecitabinedrug

oral tablets