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Pre-operative Nivolumab and Ipilimumab, Followed by Post-operative Nivolumab, for MSI/dMMR Oeso-gastric Adenocarcinoma.

Study acronym: NEONIPIGA
StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 15, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Apr 2025 to Oct 2025
    • Study completion date: Dec 2025 to Oct 2025
    v11
  2. Primary completion date: Jun 2024 to Apr 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 2024 to Dec 2025
    • Site details revised at 15 of 15 sites
    v10
  3. Study title shortened, about 13 wordsv9
  4. Re-verified, no change to tracked fieldsv8
  5. Primary completion date: Apr 2021 to Jun 2024
    • Study sites: 13 to 15
    • Secondary endpoints revised (6)
    • Eligibility criteria shortened, about 2 words
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. 2 versions Re-verified since Nov 17, 2020, no change to tracked fieldsv5-v6
  2. Start date changed from estimate of Sep 26, 2019 to Oct 23, 2019v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 19, 2019 to Sep 26, 2019
    • Site details revised at 13 of 13 sites
    v3
  4. Start date: Jul 15, 2019 to Sep 19, 2019v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a non-randomized study, open label phase II study. The purpose of this study is to evaluate the complete pathologic response rate (cPRR) with neoadjuvant nivolumab and ipilimumab combination in patients with MSI and/or dMMR localized oeso-gastric cancer.
Trial Details
NCT Number NCT04006262
Lead Sponsor GERCOR - Multidisciplinary Oncology Cooperative Group
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Localized Oesogastric Adenocarcimona, MSI and or dMMR
Related terms Microsatellite Instability
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov