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Checkpoint Inhibitor

Pembrolizumab + Trastuzumab + Chemotherapy for Esophageal Cancer

Phase 2
Recruiting
Led By Yelena Janjigian, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HER2+ esophageal, GEJ, or gastric adenocarcinoma biopsy or resection specimen as defined by local HER2 IHC3+ or IHC 2+/FISH>2.0 expression
Complete surgical resection of the primary tumor must be achievable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests if combining drugs with chemo can improve results for esophageal cancer patients with HER2+.

Who is the study for?
This trial is for adults with HER2+ esophagogastric cancer who can potentially have their tumor completely removed by surgery. They must be in good physical condition (ECOG 0-1), agree to use contraception, and not be pregnant or breastfeeding. Their organs must function well enough to handle the treatments.
What is being tested?
The study is testing if adding trastuzumab (a drug targeting HER2 proteins) and pembrolizumab (an immunotherapy drug) to standard chemotherapy improves outcomes for patients with resectable HER2+ esophagogastric cancer.
What are the potential side effects?
Trastuzumab may cause heart problems, allergic reactions, and lung issues. Pembrolizumab might lead to immune system side effects affecting various organs, fatigue, skin reactions, and infusion-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My esophageal or stomach cancer is HER2 positive.
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My primary tumor can be completely removed by surgery.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I am not pregnant, not breastfeeding, and follow birth control guidelines.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Response Rate (either cCR or pCR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with Esophagogastric CancerExperimental Treatment4 Interventions
Participants will have a diagnosis of resectable HER2+ (IHC 3+ or IHC 2+/FISH ratio \>2.0) esophageal, GEJ or gastric cancer.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2890
Capecitabine
2013
Completed Phase 3
~3960
Trastuzumab
2014
Completed Phase 4
~5190
Pembrolizumab
2017
Completed Phase 3
~2810

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,558 Previous Clinical Trials
569,411 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,005 Previous Clinical Trials
5,185,396 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,313 Total Patients Enrolled
~17 spots leftby Nov 2027
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