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Neoadjuvant Folfirinox Combined With Pembrolizumab Followed by Surgery for Patients With Resectable Pancreatic Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv12
  2. Notable Primary and study completion dates: May 21, 2025 to May 21, 2027v11
  3. Notable Primary completion date: Jul 30, 2024 to May 21, 2025 Completion date: Dec 31, 2024 to May 21, 2025v10 Show 1 more changeShow less
    • Completion date: Dec 31, 2024 to May 21, 2025
  4. Notable Primary completion date: Jan 1, 2024 to Jul 30, 2024 Completion date: Jul 1, 2024 to Dec 31, 2024v9 Show 1 more changeShow less
    • Completion date: Jul 1, 2024 to Dec 31, 2024
  5. Minor Study sites: 2 to 3 Eligibility criteria shortened, about 45 words · Collaborators: 1 to 2v8 Show 2 more changesShow less
    • Eligibility criteria shortened, about 45 words
    • Collaborators: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

Show 6 earlier versionsHide 6 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv7
  2. Minor Eligibility criteria shortened, about 13 wordsv6 See this version in full on ClinicalTrials.gov ↗
  3. Minor Eligibility criteria shortened, about 76 words Study description revisedv5 Show 1 more changeShow less
  4. Notable Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Sep 30, 2022 to Aug 31, 2022 · Site details revised at 2 of 2 sitesv4 Show 2 more changesShow less
    • Start date changed from estimate of Sep 30, 2022 to Aug 31, 2022
    • Site details revised at 2 of 2 sites
  5. Notable Start date: Apr 1, 2022 to Sep 30, 2022 Primary endpoint revised · Enrollment target: 27 to 30 · Secondary endpoints revised (4) · 1 morev3 Show 4 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 27 to 30
    • Secondary endpoints revised (4)
    • Study description expanded, about 63 words

    See this version in full on ClinicalTrials.gov ↗

  6. Notable Start date: Jan 1, 2022 to Apr 1, 2022v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Abbreviated Title: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Trial Phase: Phase II Clinical Indication: Pancreatic ductal adenocarcinoma; Adenocarcinoma; AJCC I, II, or III; 1st Line neoadjuvant Trial Type: Interventional prospective Type of control: Historical Route of administration: IV Treatment Groups: Neoadjuvant FOLFIRINOX combined with Pembrolizumab followed by surgery for patients with resectable pancreatic cancer Number of trial participants: 30 Estimated enrollment period: 24 months Estimated duration of trial: 3.5 Years Duration of Participation:16 months Estimated average length of treatment per patient: 16 months
Trial Details
NCT Number NCT05132504
Lead Sponsor Baylor College of Medicine
Collaborators: Merck Sharp & Dohme LLC, The Methodist Hospital Research Institute
Conditions Pancreatic Ductal Adenocarcinoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov