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

NCT04510285 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-02-01

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Trastuzumab

Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days).

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).

Sponsors & Collaborators

Principal Investigators

  • Yelena Y Janjigian, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-10
Primary Completion
2022-12-30
Completion
2022-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04510285 on ClinicalTrials.gov