A Single-Arm Pilot Study of Adjuvant Pembrolizumab Plus Trastuzumab in HER2+ Esophagogastric Tumors With Persistent Circulating Tumor DNA Following Curative Resection

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen byYelena Y Janjigian, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out whether treatment with trastuzumab combined with pembrolizumab will improve the clearance of tumor DNA from participants' bodies after surgery.

Research Team

Yelena Y Janjigian, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

Inclusion Criteria

Age 18 years or older.

ECOG performance status 0-2.

Sign informed consent within 8 months after curative surgery and completion of standard of care perioperative and/or adjuvant therapy.

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Treatment Details

Interventions

Pembrolizumab (Monoclonal Antibodies)
Trastuzumab (Monoclonal Antibodies)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Trastuzumab and PembrolizumabExperimental Treatment2 Interventions

Trastuzumab will be administered on an every 3 week dosing schedule, with initial loading dose of 8 mg/kg as a 90 minute infusion, followed by trastuzumab 6 mg/kg every 3 weeks. The planned dose of pembrolizumab for this study is 200 mg every 3 weeks.