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Clinical Trial of Ablation Therapy in Participants With Intermediate-Risk Non-Muscle Invasive Papillary Bladder Cancer

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Re-verified, no change to tracked fieldsv3
  2. Notable Primary completion date: May 1, 2026 to Nov 2026 Start date: May 1, 2025 to Nov 2025 · Completion date: May 1, 2029 to Nov 2029v2 Show 2 more changesShow less
    • Start date: May 1, 2025 to Nov 2025
    • Completion date: May 1, 2029 to Nov 2029
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
1,022 trials monitored
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This is an open-label, phase 2, randomized study of intravesical N-803 plus BCG (experimental arm A) and intravesical N-803 plus gemcitabine (experimental arm B) in participants who have intermediate-risk Ta/T1 papillary disease. The primary objective of this study is to evaluate the efficacy of these experimental therapies without the need for surgical intervention by CR rate at month 3 or month 6 (for re-inducted participants).
Trial Details
NCT Number NCT06829823
Lead Sponsor ImmunityBio, Inc.
Conditions Non-muscle Invasive Bladder Cancer (NMIBC)
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov