RecruitingPhase 2NCT06123338

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

A Single-Arm, Multicenter Phase 2 Study of Neoadjuvant Pembrolizumab With Trastuzumab and Chemotherapy in Resectable HER2+ Esophagogastric Tumors


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

49 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study to find out whether adding trastuzumab and pembrolizumab to standard chemotherapy is an effective treatment for resectable HER2+ esophagogastric cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding pembrolizumab (an immunotherapy drug) to the standard combination of trastuzumab (a HER2-targeted drug) and chemotherapy can improve outcomes for people with HER2-positive stomach or esophageal cancer when given before and after surgery. **You may be eligible if...** - You are 18 or older with HER2-positive stomach, gastroesophageal junction, or esophageal cancer - Your cancer is confirmed HER2-positive by a tissue biopsy test (IHC3+ or IHC2+/FISH) - Your cancer can be completely removed with surgery - You have not received any prior treatment for this cancer - Your blood counts, kidney, and liver function are adequate **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (metastatic) - You have previously received HER2-targeted therapy or immunotherapy (anti-PD-1/PD-L1) - You have received any prior treatment for this esophageal or gastric cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab will be administered on an every 3-week dosing schedule

DRUGTrastuzumab

Trastuzumab will be administered on an every 3-week dosing schedule

DRUGOxaliplatin

Oxaliplatin every 3 weeks, +/-7 days

DRUGCapecitabine

Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3 weeks

DRUG5-Fluorouracil

5-Fluorouracil administered as a 24 hour IV continuous infusion once every 2 weeks

DRUGDocetaxel

Docetaxel administered intravenously once every 2 weeks.


Locations(10)

Massachusetts General Hospital (Data Collection Only)

Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)

Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, United States

University of Pennsylvania (Data Collection Only)

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center (Data Collection Only)

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06123338


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