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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

NCT05480384 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Nivolumab

Nivolumab, 360 mg IV every 3 weeks for 17 doses (12 months)

DRUG

Trastuzumab deruxtecan

Given in combination with Nivolumab.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Brown University

    lead OTHER

Principal Investigators

  • Howard Safran, MD · Lifespan Cancer Institute

  • Manish A Shah, MD · Weill Medical College of Cornell University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-14
Primary Completion
2025-05-05
Completion
2026-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT05480384 on ClinicalTrials.gov