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Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer

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

Record History

  1. Minor Primary completion date changed from estimate of Oct 31, 2025 to Oct 13, 2025 Completion date: Oct 31, 2025 to May 31, 2026v25 Show 1 more changeShow less
    • Completion date: Oct 31, 2025 to May 31, 2026
  2. Minor 2 versions Re-verified since May 14, 2025, no change to tracked fieldsv23-v24
  3. Notable Primary and study completion dates: Oct 31, 2024 to Oct 31, 2025v22
  4. Minor Primary completion date: Jun 30, 2024 to Oct 31, 2024 Completion date: Sep 30, 2024 to Oct 31, 2024v21 Show 1 more changeShow less
    • Completion date: Sep 30, 2024 to Oct 31, 2024
  5. Minor Trial status: Recruiting to Active, Not Recruiting Site details revised at 4 of 4 sitesv20 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
Show 18 earlier versionsHide 18 earlier versions
  1. Minor Eligibility criteria expanded, about 30 words Study title shortened, about 3 wordsv19 Show 1 more changeShow less
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Site contacts updated at 1 of 4 sitesv18
  3. Minor Re-verified, no change to tracked fieldsv17
  4. Minor Site details revised at 1 of 4 sitesv16
  5. Minor Study sites: 3 to 4v15
  6. Minor Re-verified, no change to tracked fieldsv14
  7. Notable Primary endpoint revised Enrollment target: 248 to 328 · Secondary endpoints revised (3)v13 Show 2 more changesShow less
    • Enrollment target: 248 to 328
    • Secondary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  8. Notable Primary completion date: Jun 30, 2021 to Jun 30, 2024 Completion date: Jun 30, 2022 to Sep 30, 2024v12 Show 1 more changeShow less
    • Completion date: Jun 30, 2022 to Sep 30, 2024
  9. Minor Site contacts updated at 1 of 3 sites Eligibility criteria expanded, about 5 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  10. Minor Re-verified, no change to tracked fieldsv10
  11. Minor Site contacts updated at 1 of 3 sitesv9
  12. Minor Eligibility criteria shortened, about 41 wordsv8 See this version in full on ClinicalTrials.gov ↗
  13. Minor Study sites: 2 to 3 Eligibility criteria shortened, about 21 wordsv7 Show 1 more changeShow less
    • Eligibility criteria shortened, about 21 words

    See this version in full on ClinicalTrials.gov ↗

  14. Minor Enrollment target: 268 to 248 Study sites: 1 to 2v6 Show 1 more changeShow less
    • Study sites: 1 to 2
  15. Minor Start date changed from estimate of Jun 20, 2020 to Jul 21, 2020 Site contact updatedv5 Show 1 more changeShow less
    • Site contact updated
  16. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: May 11, 2023 to Jun 30, 2021 · Study sites: 0 to 1 · Completion date: May 11, 2023 to Jun 30, 2022 · 1 morev4 Show 4 more changesShow less
    • Primary completion date: May 11, 2023 to Jun 30, 2021
    • Study sites: 0 to 1
    • Completion date: May 11, 2023 to Jun 30, 2022
    • Start date: Jun 1, 2020 to Jun 20, 2020
  17. Minor Start date: May 11, 2020 to Jun 1, 2020v3
  18. Minor Secondary endpoints revised (3)v2 See this version in full on ClinicalTrials.gov ↗
  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.
This is a phase 2, three-cohort (2 randomized and 1 single-arm), open-label study to evaluate the comparative efficacy and overall safety of standard-of-care chemotherapy versus standard-of-care chemotherapy in combination with aldoxorubicin HCl, N-803, and PD-L1 t-haNK in subjects with locally advanced or metastatic pancreatic cancer. Each treatment setting (ie, first line maintenance, second line, or third line or greater) will be evaluated independently as a separate cohort.
Trial Details
NCT Number NCT04390399
Lead Sponsor ImmunityBio, Inc.
Conditions Pancreatic Cancer
Enrollment 328 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov