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A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary endpoints: details revised at 1 of 3 entries
    • Eligibility criteria expanded, about 53 words
    • Site details revised at 2 of 11 sites
  2. Study sites: 12 to 11v34
  3. Re-verified, no change to tracked fieldsv33
  4. Study sites revised (12)v32
  5. Re-verified, no change to tracked fieldsv31
Show 29 earlier versionsHide 29 earlier versions
  1. Study sites revised (12)v30
  2. Primary completion date: Jun 30, 2024 to Apr 30, 2030
    • Study completion date: Jun 30, 2025 to Apr 30, 2031
    v29
  3. Primary completion date: Jun 30, 2023 to Jun 30, 2024
    • Start date: Jun 7, 2019 to Mar 9, 2020
    • Study completion date: Jun 30, 2023 to Jun 30, 2025
    v28
  4. Re-verified, no change to tracked fieldsv27
  5. Eligibility criteria shortened, about 4 wordsv26
  6. Primary completion date: Dec 31, 2022 to Jun 30, 2023v25
  7. Study title expanded, about 24 wordsv24
  8. Primary endpoints revised (3)
    • Study title expanded, about 8 words
    v23
  9. Study sites: 11 to 12
    • Interventions: Durvalumab (Drug), Prednisone (Drug), Prednisone (Drug) to Durvalumab (Drug), Prednisone (Drug), Prednisone (Drug), Tremelimumab (Drug)
    v22
  10. Study sites: 10 to 11v21
  11. Study sites: 8 to 10v20
  12. Primary completion date: Jun 30, 2022 to Dec 31, 2022
    • Study sites: 7 to 8
    • Study completion date: Dec 31, 2022 to Jun 30, 2023
    v19
  13. Study sites: 6 to 7v18
  14. Study sites: 5 to 6v17
  15. Primary endpoints: 1 to 3
    • Eligibility criteria expanded, about 174 words
    • Secondary endpoints revised (3)
    • Study title shortened, about 7 words
    v16
  16. Site contacts updated at 1 of 5 sitesv15
  17. Primary completion date: Dec 31, 2021 to Jun 30, 2022v14
  18. Site contacts updated at 1 of 5 sitesv13
  19. Eligibility criteria shortened, about 7 wordsv12
  20. Study sites: 4 to 5v11
  21. Site details revised at 2 of 4 sitesv10
  22. Study sites: 2 to 4v9
  23. Site details revised at 1 of 2 sitesv8
  24. Primary completion date: Dec 2021 to Dec 31, 2021
    • Study completion date: Dec 2022 to Dec 31, 2022
    v7
  25. Study sites: 1 to 2v6
  26. Re-verified, no change to tracked fieldsv5
  27. Eligibility criteria expanded, about 96 words
    • Study title revised
    v4
  28. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 31, 2019 to Jun 7, 2019
    v3
  29. Start date: Feb 2019 to Mar 31, 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.
I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects. I238B: The purpose of this study is to allow patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab)
Trial Details
NCT Number NCT03847649
Lead Sponsor Canadian Cancer Trials Group
Collaborators: AstraZeneca
Conditions
(from sponsor)		 Cancer
Related terms Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov