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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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Apr 9, 2025 to May 5, 2025v14
  2. Study completion pushed from Jan 2026 to May 2026v13
  3. Enrollment target: estimated 25 to confirmed 1v12 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Sep 2025 to Apr 9, 2025
    • Study completion date: Sep 2027 to Jan 2026
    • Site details revised at 2 of 2 sites
  4. Primary completion date: Jan 2025 to Sep 2025
    • Study completion date: Jan 2027 to Sep 2027
    v11
  5. 2 versions Re-verified since Aug 1, 2023, no change to tracked fieldsv9-v10
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Aug 1, 2023 to Jul 14, 2023
    • Site details revised at 2 of 2 sites
    • Study title shortened, about 2 words
    v8
  2. Start date: May 1, 2023 to Aug 1, 2023v7
  3. Start date: Mar 1, 2023 to May 1, 2023v6
  4. 2 versions Re-verified since Feb 15, 2023, no change to tracked fieldsv4-v5
  5. Start date: Nov 2022 to Mar 1, 2023v3
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05480384
Lead Sponsor Brown University
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Esophageal Adenocarcinoma, Esophageal Cancer, HER-2 Protein Overexpression, Gastroesophageal-junction Cancer
Related terms Adenocarcinoma Of Esophagus, Esophageal Neoplasms
Enrollment 1 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov