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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathological Complete Response Rate (pCR)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Participants with Esophagogastric CancerExperimental Treatment2 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

Pembrolizumab

2017

Completed Phase 2

~2010

Trastuzumab

2014

Completed Phase 4

~5190

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,118 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,121 Total Patients Enrolled

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,873 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies in this medical trial that could be filled by prospective participants?

"Clinicaltrials.gov affirms that this research study is not currently enrolling participants. Initially posted on November 30th 2023 and last updated on the 3rd of November, there are 1112 other studies seeking recruits at present."

Answered by AI

What risks are associated with Esophagogastric Cancer for individuals?

"The safety of this medication for the treatment of esophagogastric cancer was rated at a 2, as there is only data confirming its security and not its efficacy."

Answered by AI

In what areas is the oversight of this investigation taking place?

"The current iteration of this clinical trial is being conducted at Johns Hopkins University in Baltimore, Massachusetts General Hospital in Boston, and Memorial Sloan Kettering Basking Ridge in New jersey. Additionally there are 9 other sites participating."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer

2024. "A Study of Pembrolizumab With Trastuzumab and Chemotherapy in People With Esophagogastric Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06123338.

All > Gastric Cancer