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Checkpoint Inhibitor

Pembrolizumab for Stomach Cancer

Phase 2
Waitlist Available
Led By Gulam Manji, MD, PhD
Research Sponsored by Gulam Manji
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment initiation until death or study end, whichever occurs first (up to approximately 5 years)
Awards & highlights

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.

Eligible Conditions
  • Stomach Cancer
  • Gastroesophageal Junction Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment initiation until death or study end, whichever occurs first (up to approximately 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment initiation until death or study end, whichever occurs first (up to approximately 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pathologic Complete Response (pCR) Rate
Secondary study objectives
Disease Free Survival (DFS)
Overall Response Rate (ORR)
Overall Survival (OS)

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment2 Interventions
All study subjects will receive standard of care chemotherapy regimen for 3 cycles prior to and 3 cycles following surgery in combination with Pembrolizumab with an additional cycle of Pembrolizumab (4 total) in the pre-operative period. Additionally subjects will complete 12 months of maintenance Pembrolizumab (14 additional doses to complete 17 post-operative cycles) following completion of post-operative chemotherapy. Standard of care combination chemotherapy regimen has a 21-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Standard of care chemotherapy regimen
2017
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Gulam ManjiLead Sponsor
4 Previous Clinical Trials
114 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,471 Previous Clinical Trials
2,536,301 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,934 Total Patients Enrolled
~6 spots leftby Sep 2025
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