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Autoimmunity After Checkpoint Blockade

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years 7 months later Jun 30, 2026 → Feb 24, 2030
See other at-risk trials from Abramson Cancer Center at Penn Medicine

Record History

  1. Primary and study completion pushed from Jun 30, 2026 to Feb 24, 2030 Secondary endpoints: details revised at 1 of 1 entry · Eligibility criteria expanded, about 4 words Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 4 words
  2. Lead sponsor: University of Pennsylvania to Abramson Cancer Center at Penn Medicine Enrollment target: 300 to 600 · Secondary endpoints: details revised at 1 of 1 entry · Study description expanded, about 3 wordsv14 Show 3 more changesShow less
    • Enrollment target: 300 to 600
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv13
  4. Primary and study completion dates: Jan 1, 2024 to Jun 30, 2026v12
  5. Primary completion date: Feb 24, 2023 to Jan 1, 2024v11
Show 9 earlier versionsHide 9 earlier versions
  1. Site contact updatedv10
  2. Study description shortened, about 3 wordsv9 See this version in full on ClinicalTrials.gov ↗
  3. Secondary endpoints: details revised at 1 of 1 entry Study description expanded, about 233 wordsv8 Show 1 more changeShow less
    • Study description expanded, about 233 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Active, Not Recruiting to Recruiting Site details revisedv7 Show 1 more changeShow less
    • Site details revised
  5. Trial status: Recruiting to Active, Not Recruiting Site details revisedv6 Show 1 more changeShow less
    • Site details revised
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1v5 Show 1 more changeShow less
    • Study sites: 0 to 1
  7. Re-verified, no change to tracked fieldsv4
  8. Start date: Dec 1, 2019 to Feb 24, 2020 Primary completion date: Jan 1, 2023 to Feb 24, 2023v3 Show 1 more changeShow less
    • Primary completion date: Jan 1, 2023 to Feb 24, 2023
  9. Start date: Nov 1, 2019 to Dec 1, 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to better understand how the treatment of cancer with immune checkpoint inhibitors (ICI) leads to the development of autoimmunity. Specifically, we wish to understand the genetics and immune system features that cause a subset of cancer patients treated with checkpoint inhibitor therapy to develop an immune-related adverse event (irAE).
Trial Details
NCT Number NCT04119713
Lead Sponsor Abramson Cancer Center at Penn Medicine
Conditions Autoimmunity, Cancer, Immunotoxicity, Oncology
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov