NCT05480384

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Brown University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Esophageal Adenocarcinoma
• Esophageal Cancer
• HER-2 Protein Overexpression
• Gastroesophageal-junction Cancer

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab, 360 mg IV every 3 weeks for 17 doses (12 months)
DRUG	Trastuzumab deruxtecan	Given in combination with Nivolumab.

Timeline

• Start date: 2023-07-14
• Primary completion: 2025-04-09
• Completion: 2026-05-01
• First posted: 2022-07-29
• Last updated: 2026-04-01

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study