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DEWI: Watch-and-Wait With Dostarlimab in Localized dMMR/MSI-H Gastric/GEJ Adenocarcinoma Phase II Study

Study acronym: DEWI
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Secondary endpoints revised (14)v5
  2. Notable Enrollment increased: 59 → 89 participantsv4 Show 6 more changesShow less
    • Start date: Dec 18, 2023 to Jan 22, 2024
    • Trial sites expanded: 2 → 18 locations
    • Eligibility criteria expanded, about 340 words
    • Secondary endpoints: 6 to 14
    • Study description expanded, about 37 words
    • Study title shortened, about 1 word
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jan 15, 2024 to Dec 18, 2023
    v3
  4. Notable Start date: Sep 20, 2023 to Jan 15, 2024v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This phase II study evaluates dostarlimab followed by a watch-and-wait strategy in patients with localized dMMR/MSI-H gastric or gastroesophageal junction (GEJ) adenocarcinoma. The study aims to determine whether surgery can be safely avoided in patients achieving a complete response, defined by negative endoscopy and tumor-free biopsies after treatment.
Trial Details
NCT Number NCT06059495
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions
(from sponsor)
Adenocarcinoma - GEJ, Gastric Adenocarcinoma
Enrollment 89 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov