NCT06123338

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Eligible patients will receive 8 peri-operative cycles of pembrolizumab and trastuzumab with chemotherapy (fluoropyrimidine/oxaliplatin doublet for patients initially enrolled and subsequently FLOT \[5-fluorouracil, oxaliplatin and docetaxel\] followed by pembrolizumab and trastuzumab maintenance to complete 1 total year of therapy.

Conditions

• Esophageal Cancer
• Gastric Adenocarcinoma
• HER2 Gene Mutation

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab will be administered on an every 3-week dosing schedule
DRUG	Trastuzumab	Trastuzumab will be administered on an every 3-week dosing schedule
DRUG	Oxaliplatin	Oxaliplatin every 3 weeks, +/-7 days
DRUG	Capecitabine	Capecitabine twice daily on days 1 to 14 every 3 weeks or 5-FU on days 1 to 5 every 3 weeks
DRUG	5-Fluorouracil	5-Fluorouracil administered as a 24 hour IV continuous infusion once every 2 weeks
DRUG	Docetaxel	Docetaxel administered intravenously once every 2 weeks.

Timeline

• Start date: 2024-02-01
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2023-11-08
• Last updated: 2026-01-29

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study