Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT02546661 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

Study acronym: BISCAY
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 51 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 17 entries Completion pushed from Jan 30, 2026 to Nov 30, 2026 · Eligibility criteria expanded, about 22 words · Secondary endpoints: details revised at 3 of 16 entries · 1 more Show 4 more changesShow less
    • Completion pushed from Jan 30, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 22 words
    • Secondary endpoints: details revised at 3 of 16 entries
    • Publications: details revised at 2 of 2 entries
  2. Completion date: Jan 9, 2026 to Jan 30, 2026v50
  3. 2 versions Re-verified since Jul 25, 2025, no change to tracked fieldsv48-v49
  4. Completion date: Mar 7, 2025 to Jan 9, 2026v47
  5. Start date: Oct 3, 2016 to Dec 28, 2016 Enrollment target: 156 to 117 · Completion date: Jun 28, 2024 to Mar 7, 2025 · Publications: details revised at 1 of 2 entriesv46 Show 3 more changesShow less
    • Enrollment target: 156 to 117
    • Completion date: Jun 28, 2024 to Mar 7, 2025
    • Publications: details revised at 1 of 2 entries
Show 44 earlier versionsHide 44 earlier versions
  1. Re-verified, no change to tracked fieldsv45
  2. Completion date: Sep 29, 2023 to Jun 28, 2024v44
  3. Re-verified, no change to tracked fieldsv43
  4. Completion date: Mar 31, 2023 to Sep 29, 2023v42
  5. Completion date: Sep 12, 2022 to Mar 31, 2023v41
  6. Completion date: Feb 14, 2022 to Sep 12, 2022v40
  7. 2 versions Re-verified since Jul 22, 2020, no change to tracked fieldsv38-v39
  8. Primary completion date changed from estimate of Mar 12, 2020 to Mar 18, 2020 Completion date: Mar 12, 2020 to Feb 14, 2022v37 Show 1 more changeShow less
    • Completion date: Mar 12, 2020 to Feb 14, 2022
  9. 2 versions Re-verified since Sep 26, 2019, no change to tracked fieldsv35-v36
  10. Study sites: 26 to 27v34
  11. Re-verified, no change to tracked fieldsv33
  12. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 196 to confirmed 156 · Study sites: 37 to 26 · Primary and study completion dates: Mar 20, 2020 to Mar 12, 2020v32 Show 3 more changesShow less
    • Enrollment target: estimated 196 to confirmed 156
    • Study sites: 37 to 26
    • Primary and study completion dates: Mar 20, 2020 to Mar 12, 2020
  13. Primary endpoints: 15 to 17 Primary and study completion dates: Mar 27, 2020 to Mar 20, 2020v31 Show 1 more changeShow less
    • Primary and study completion dates: Mar 27, 2020 to Mar 20, 2020

    See this version in full on ClinicalTrials.gov ↗

  14. 2 versions Re-verified since Jan 9, 2019, no change to tracked fieldsv29-v30
  15. Study sites: 35 to 37 Primary and study completion dates: Nov 29, 2019 to Mar 27, 2020v28 Show 1 more changeShow less
    • Primary and study completion dates: Nov 29, 2019 to Mar 27, 2020
  16. Re-verified, no change to tracked fieldsv27
  17. Primary endpoints: 14 to 15 Enrollment target: 140 to 196 · Study sites: 34 to 35 · Interventions: AZD1775 (Drug), AZD4547 (Drug), AZD9150 (Drug), Durvalumab (Drug), Olaparib (Drug), Vistusertib (Drug) to AZD1775 (Drug), AZD4547 (Drug), AZD9150 (Drug), MEDI4736 (Drug), Olaparib (Drug), Selumetinib (Drug), Vistusertib (Drug) · 4 morev26 Show 7 more changesShow less
    • Enrollment target: 140 to 196
    • Study sites: 34 to 35
    • Interventions: AZD1775 (Drug), AZD4547 (Drug), AZD9150 (Drug), Durvalumab (Drug), Olaparib (Drug), Vistusertib (Drug) to AZD1775 (Drug), AZD4547 (Drug), AZD9150 (Drug), MEDI4736 (Drug), Olaparib (Drug), Selumetinib (Drug), Vistusertib (Drug)
    • Eligibility criteria expanded, about 166 words
    • Secondary endpoints: 15 to 16
    • Study description shortened, about 211 words
    • Study arms: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  18. Site details revised at 1 of 34 sitesv25
  19. Primary and study completion dates: Apr 19, 2019 to Nov 29, 2019v24
  20. Study sites: 32 to 34v23
  21. Study sites: 31 to 32v22
  22. Re-verified, no change to tracked fieldsv21
  23. Study sites: 30 to 31v20
  24. Enrollment target: 110 to 140 Study sites: 27 to 30v19 Show 1 more changeShow less
    • Study sites: 27 to 30
  25. Study sites: 26 to 27 Primary and study completion dates: Mar 21, 2019 to Apr 19, 2019v18 Show 1 more changeShow less
    • Primary and study completion dates: Mar 21, 2019 to Apr 19, 2019
  26. Primary endpoints: 13 to 14 Interventions: AZD1775 (Drug), AZD4547 (Drug), Durvalumab (Drug), Olaparib (Drug), Vistusertib (Drug) to AZD1775 (Drug), AZD4547 (Drug), AZD9150 (Drug), Durvalumab (Drug), Olaparib (Drug), Vistusertib (Drug) · Eligibility criteria expanded, about 70 words · Secondary endpoints: 12 to 15 · 2 morev17 Show 5 more changesShow less
    • Interventions: AZD1775 (Drug), AZD4547 (Drug), Durvalumab (Drug), Olaparib (Drug), Vistusertib (Drug) to AZD1775 (Drug), AZD4547 (Drug), AZD9150 (Drug), Durvalumab (Drug), Olaparib (Drug), Vistusertib (Drug)
    • Eligibility criteria expanded, about 70 words
    • Secondary endpoints: 12 to 15
    • Study description expanded, about 34 words
    • Study arms: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  27. Study sites: 23 to 26v16
  28. Re-verified, no change to tracked fieldsv15
  29. Study sites: 18 to 23v14
  30. Re-verified, no change to tracked fieldsv13
  31. Study sites: 6 to 18 Primary and study completion dates: Mar 2019 to Mar 21, 2019 · Start date: Oct 2016 to Oct 3, 2016v12 Show 2 more changesShow less
    • Primary and study completion dates: Mar 2019 to Mar 21, 2019
    • Start date: Oct 2016 to Oct 3, 2016
  32. Study sites: 4 to 6v11
  33. Primary and study completion dates: May 2018 to Mar 2019 Primary endpoints: 2 to 13 · Interventions: AZD4547 (Drug), Durvalumab + AZD1775 (Drug), Durvalumab + AZD4547 (Drug), Durvalumab + Olaparib (Drug), Durvalumab monotherapy (Drug) to AZD1775 (Drug), AZD4547 (Drug), Durvalumab (Drug), Olaparib (Drug), Vistusertib (Drug) · Eligibility criteria shortened, about 39 words · 2 morev10 Show 5 more changesShow less
    • Primary endpoints: 2 to 13
    • Interventions: AZD4547 (Drug), Durvalumab + AZD1775 (Drug), Durvalumab + AZD4547 (Drug), Durvalumab + Olaparib (Drug), Durvalumab monotherapy (Drug) to AZD1775 (Drug), AZD4547 (Drug), Durvalumab (Drug), Olaparib (Drug), Vistusertib (Drug)
    • Eligibility criteria shortened, about 39 words
    • Secondary endpoints: 33 to 12
    • Study arms: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  34. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 2016 to Oct 2016 · Study sites: 2 to 4 · Primary and study completion dates: Jun 2018 to May 2018 · 1 morev9 Show 4 more changesShow less
    • Start date: Aug 2016 to Oct 2016
    • Study sites: 2 to 4
    • Primary and study completion dates: Jun 2018 to May 2018
    • Study description expanded, about 50 words

    See this version in full on ClinicalTrials.gov ↗

  35. Start date: Jun 2016 to Aug 2016 Trial status: Recruiting to Not Yet Recruiting · Site details revised at 2 of 2 sitesv8 Show 2 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Site details revised at 2 of 2 sites
  36. Trial status: Not Yet Recruiting to Recruiting Enrollment target: 40 to 110 · Start date: May 2016 to Jun 2016 · Site details revised at 2 of 2 sitesv7 Show 3 more changesShow less
    • Enrollment target: 40 to 110
    • Start date: May 2016 to Jun 2016
    • Site details revised at 2 of 2 sites
  37. Primary endpoints: 9 to 2 Study sites: 1 to 2 · Start date: Apr 2016 to May 2016 · Interventions: AZD4547 (Drug), AZD4547 + MEDI4736 (Drug) to AZD4547 (Drug), Durvalumab + AZD1775 (Drug), Durvalumab + AZD4547 (Drug), Durvalumab + Olaparib (Drug), Durvalumab monotherapy (Drug) · 4 morev6 Show 7 more changesShow less
    • Study sites: 1 to 2
    • Start date: Apr 2016 to May 2016
    • Interventions: AZD4547 (Drug), AZD4547 + MEDI4736 (Drug) to AZD4547 (Drug), Durvalumab + AZD1775 (Drug), Durvalumab + AZD4547 (Drug), Durvalumab + Olaparib (Drug), Durvalumab monotherapy (Drug)
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 9 to 33
    • Study description expanded, about 313 words
    • Study arms: 2 to 5

    See this version in full on ClinicalTrials.gov ↗

  38. Start date: Feb 2016 to Apr 2016v5
  39. Start date: Dec 2015 to Feb 2016v4
  40. Start date: Oct 2015 to Dec 2015 Study sites: 0 to 1v3 Show 1 more changeShow less
    • Study sites: 0 to 1
  41. Primary and study completion dates: Dec 2016 to Jun 2018 Start date: Sep 2015 to Oct 2015v2 Show 1 more changeShow less
    • Start date: Sep 2015 to Oct 2015
  • 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.
AstraZeneca
727 trials monitored
See 61 trials at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
This is an open label, multi-drug, biomarker-directed, multi-centre, multi-arm, Phase 1b study in patients with muscle invasive bladder cancer (MIBC) (urothelial) who have progressed on prior treatment. This study is modular in design, allowing evaluation of the safety, tolerability, pharmacokinetics and anti-tumour activity of multiple agents as monotherapy and as combinations of different novel anti-cancer agents. The study will consist of a number of study modules (sub-studies), each evaluating the safety and tolerability of a specific agent or combination.
Trial Details
NCT Number NCT02546661
Lead Sponsor AstraZeneca
Conditions Muscle Invasive Bladder Cancer
Enrollment 117 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov