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Perioperative Durvalumab With Neoadjuvant ddMVAC in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from AstraZeneca

Record History

  1. Primary endpoint(s) modified Phase changed: Phase 3 → Phase 2 · Primary and study completion moved earlier from Oct 31, 2028 to Aug 30, 2028 · Eligibility criteria expanded, about 7 words · 3 more Show 6 more changesShow less
    • Phase changed: Phase 3 → Phase 2
    • Primary and study completion moved earlier from Oct 31, 2028 to Aug 30, 2028
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (6)
    • Site details revised at 7 of 59 sites
    • Study title shortened, about 2 words
  2. Site details revised at 31 of 59 sitesv15
  3. 4 versions Re-verified since Feb 20, 2026, no change to tracked fieldsv11-v14
  4. Study sites: 54 to 59v10
  5. Re-verified, no change to tracked fieldsv9
Show 7 earlier versionsHide 7 earlier versions
  1. Site details revised at 1 of 54 sitesv8
  2. Site details revised at 7 of 54 sitesv7
  3. Re-verified, no change to tracked fieldsv6
  4. Study sites: 52 to 54v5
  5. Re-verified, no change to tracked fieldsv4
  6. Study sites: 51 to 52v3
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 49 to 51 · Start date changed from estimate of Apr 30, 2025 to May 15, 2025v2 Show 2 more changesShow less
    • Study sites: 49 to 51
    • Start date changed from estimate of Apr 30, 2025 to May 15, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AstraZeneca
727 trials monitored
See 61 trials at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
The Phase II NIAGARA-2 study aims to expand on the data from the Phase III NIAGARA study by investigating perioperative durvalumab in combination with cisplatin based neoadjuvant chemotherapy in a clinical practice setting.
Trial Details
NCT Number NCT06960577
Lead Sponsor AstraZeneca
Conditions Urinary Bladder Neoplasms, Immune Checkpoint Inhibitors, Methotrexate, Vinblastine, Doxorubicin, Cisplatin, Gemcitabine
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov