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Adjuvant Trastuzumab Deruxtecan (Enhertu) & Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2+ Cancers of Esophagus & Gastroesophageal Junction

Esophageal Cancer Clinical Trial

Official title:
BrUOG 413: A Phase II Study of Adjuvant Trastuzumab Deruxtecan (Enhertu) + Nivolumab For Patients Who Are Disease Free After Completion of Trimodality Treatment For HER-2-Positive Cancers of the Esophagus and Gastroesophageal Junction

Clinical Trial Summary

An open label phase II study to determine the safety and preliminary efficacy of the combination of 1-year of adjuvant trastuzumab deruxtecan and nivolumab for patients with HER2 overexpressing esophagogastric adenocarcinoma who have completed chemoradiation followed by esophagectomy.

Clinical Trial Description

This is an open label phase II study to determine the safety and preliminary efficacy of the combination of 1-year of adjuvant trastuzumab deruxtecan and nivolumab for patients with HER2 overexpressing esophagogastric adenocarcinoma who have completed chemoradiation followed by esophagectomy. All patients will receive trastuzumab deruxtecan, 6.4 mg/kg IV, and nivolumab, 360 mg IV, every 21 days, for 17 doses over 1 year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05480384
Study type Interventional
Source Brown University
Contact Brown University Oncology Research Group
Phone 401-863-3000
Email BrUOG@brown.edu
Status Recruiting
Phase Phase 2
Start date July 14, 2023
Completion date January 2027
View Details
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