CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 37 enrolled
Drug / intervention
pembrolizumab +5 moredrug
Likely dose
Oxaliplatin 130 mg/m2from 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/NCT02954536
NCT02954536Phase 2Completed

Phase II Trial of Pembrolizumab in Combination With Trastuzumab, Fluoropyrimidine, and Platinum Chemotherapy in First Line Stage IV HER2-positive Metastatic Esophagogastric (EG) Cancer

Memorial Sloan Kettering Cancer Center·interventional·Posted Nov 3, 2016·Updated Mar 16, 2023

In Brief

A Phase 2 clinical trial evaluating pembrolizumab, trastuzumab, and 4 other interventions for Esophageal Cancer and Gastric Cancer. Completed, enrolled 37 participants across 8 sites.

Detailed Summary

The purpose of this study is to find out what effects, good and/or bad, pembrolizumab in combination with trastuzumab and chemotherapy, has on the patients' esophagogastric cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 3, 2016
Enrollment StartNov 3, 2016
Primary CompletionJun 1, 2022
Study CompletionMar 14, 2023
TodayJul 2, 2026
Enrollment to primary: 5.6 yearsPosted 9.7 years ago

Interventions

pembrolizumabdrug

trastuzumabdrug

capecitabinedrug

cisplatindrug

Oxaliplatindrug

Oxaliplatin may be administered instead, at a dose of 130 mg/m2/day as an I.V.over approximately 2 hours on Day 1 every 21-day cycles, up to a maximum of 8 cycles in the absence of disease progression or until other withdrawl criteria are met. Patients may begin with reduced dose of oxaliplatin 104 mg/m2 as starting dose if deemed necessary per the treating physician discretion. Oxaliplatin will be administered after the completion of the pembrolizumab infusion.

5-Fluorouracildrug

Only for patients unable to take oral medications (because of certain circumstances such as malabsorption, difficulty swallowing, or other conditions that could affect intake of oral capecitabine medication), 5-FU may be administered instead, at a dose of 800 mg/m2/day as a continuous infusion over 5 days (Day 1 to Day 5 of each cycle), every 21 days. This decision should be made prior to registration by the treating physician; switching from capecitabine to 5-FU, or vice versa, will not be allowed during the study. 5-FU will be administered after completion of the cisplatin infusion.