Platform Study of Neoadjuvant and Adjuvant Immunotherapy for Patients With Resectable Adenocarcinoma of the Pancreas

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 3 months later Sep 30, 2026 → Dec 31, 2026
See other at-risk trials from Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Sep 30, 2026 to Dec 31, 2026
    • Eligibility criteria expanded, about 15 words
    • Publications: details revised at 1 of 1 entry
  2. Primary and study completion dates: May 31, 2026 to Sep 30, 2026v27
  3. Re-verified, no change to tracked fieldsv26
  4. Primary completion date: Oct 31, 2025 to May 31, 2026v25
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v24
Show 22 earlier versionsHide 22 earlier versions
  1. Primary completion date: Aug 31, 2025 to Oct 31, 2025
    • Study completion date: Aug 31, 2026 to May 31, 2026
    v23
  2. Primary completion date: Dec 31, 2024 to Aug 31, 2025
    • Study completion date: Dec 31, 2025 to Aug 31, 2026
    v22
  3. 2 versions Re-verified since Aug 22, 2024, no change to tracked fieldsv20-v21
  4. Eligibility criteria expanded, about 2 wordsv19
  5. Primary completion date: Jun 30, 2023 to Dec 31, 2024
    • Study completion date: Jun 30, 2024 to Dec 31, 2025
    v18
  6. Re-verified, no change to tracked fieldsv17
  7. Primary completion date: Jun 2023 to Jun 30, 2023
    • Study completion date: Jun 2024 to Jun 30, 2024
    v16
  8. Phase: Phase 1/2 to Phase 2v15
  9. Primary completion date: Jun 2022 to Jun 2023v14 Show 8 more changesShow less
    • Primary endpoints: 1 to 4
    • Enrollment target: 62 to 76
    • Study completion date: Feb 2023 to Jun 2024
    • Interventions: Cyclophosphamide (Drug), GVAX pancreatic cancer (Biological), Nivolumab (Drug), Urelumab (Drug) to BMS-986253 (Drug), Cyclophosphamide (Drug), GVAX pancreatic cancer (Biological), Nivolumab (Drug), Urelumab (Drug)
    • Eligibility criteria shortened, about 99 words
    • Secondary endpoints revised (3)
    • Study arms: 3 to 4
    • Study title shortened, about 3 words
  10. Start date: Feb 2016 to Mar 28, 2016v13
  11. Re-verified, no change to tracked fieldsv12
  12. Enrollment target: 75 to 62v11
  13. Primary completion date: Jun 2019 to Jun 2022
    • Study completion date: Feb 2020 to Feb 2023
    v10
  14. Enrollment target: 50 to 75v9 Show 4 more changesShow less
    • Interventions: Cyclophosphamide (Drug), GVAX pancreatic cancer (Biological), Nivolumab (Drug) to Cyclophosphamide (Drug), GVAX pancreatic cancer (Biological), Nivolumab (Drug), Urelumab (Drug)
    • Collaborators expanded, about 6 words
    • Study arms: 2 to 3
    • Study title expanded, about 2 words
  15. Primary completion date: Feb 2018 to Jun 2019v8
  16. 2 versions Re-verified since Aug 22, 2016, no change to tracked fieldsv6-v7
  17. Study description expanded, about 9 wordsv5
  18. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Study completion date: Feb 2020
    • Eligibility criteria revised
    • Study description expanded, about 318 words
  19. Start date: Aug 2015 to Feb 2016
    • Primary completion date: Aug 2017 to Feb 2018
    v3
  20. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • 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 platform trial will evaluate various immunotherapy combinations given in the neo-adjuvant and adjuvant setting in patients with surgically resectable pancreatic ductal adenocarcinoma.
Trial Details
NCT Number NCT02451982
Lead Sponsor Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators: National Cancer Institute (NCI), Bristol-Myers Squibb
Conditions
(from sponsor)		 Pancreatic Cancer
Related terms Pancreatic Neoplasms
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov