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Perioperative Chemo and Pembrolizumab in Gastric Cancer

NCT02918162 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2024-02-15

Study results available
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Summary

This is a non-randomized, multi-site, open-label trial of pembrolizumab and chemotherapy in subjects with gastric or gastroesophageal (GE) junction adenocarcinoma. The purpose of this study is to determine and evaluate the efficacy of combination therapy with immune checkpoint blockade and chemotherapy used in the perioperative period in eradicating micrometastatic disease; and to compare paired tissue and serum samples (pre-treatment and post-treatment) from individually treated patients to explore the immune effects of combination therapy and predictors of response.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab dosed IV at 200mg every 21 days per cycle.

DRUG

Standard of care chemotherapy regimen

Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician. Example: Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily.

Sponsors & Collaborators

Principal Investigators

  • Gulam Manji, MD, PhD · Columbia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-25
Primary Completion
2023-02-28
Completion
2023-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02918162 on ClinicalTrials.gov