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N-803 in Combination With Pembrolizumab and Enfortumab Vedotin for Treatment of Urothelial Cancer

StatusNot Yet Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status changed: Withdrawn → Not Yet Recruiting Lead sponsor: Vadim S Koshkin to ImmunityBio, Inc. · Primary completion date: May 30, 2027 to Jan 2028 · Start date: Feb 15, 2026 to Dec 2026 · 9 more Show 12 more changesShow less
    • Lead sponsor: Vadim S Koshkin to ImmunityBio, Inc.
    • Primary completion date: May 30, 2027 to Jan 2028
    • Start date: Feb 15, 2026 to Dec 2026
    • Primary endpoints: 3 to 2
    • Enrollment target: 0 to 18
    • Study sites: 0 to 1
    • Completion date: May 30, 2027 to Jan 2032
    • Interventions: Enfortumab Vedotin (EV) (Drug), Nogapendekin Alfa Inbakicept (N803) (Drug), Pembrolizumab (Drug), Radiographic Imaging (Procedure)… to Nogapendekin Alfa Inbakicept (NAI) (Drug), Pembrolizumab (Drug), enfortumab vedotin (EV) (Drug)
    • Eligibility criteria expanded, about 48 words
    • Secondary endpoints: 6 to 2
    • Study description shortened, about 203 words
    • Collaborators shortened, about 2 words
  2. Trial status: Not Yet Recruiting to Withdrawn Sponsor's reason: Business decision Enrollment target: estimated 18 to confirmed 0 · Study sites: 1 to 0v3 Show 2 more changesShow less
    • Enrollment target: estimated 18 to confirmed 0
    • Study sites: 1 to 0
  3. Start date: Nov 30, 2025 to Feb 15, 2026v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
ImmunityBio, Inc.
33 trials monitored
See 2 trials at risk
Bladder Cancer
1,022 trials monitored
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This phase Ib trial will investigate the effect of N-803 in combination with pembrolizumab and enfortumab vedotin in treating participants with urothelial cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic).
Trial Details
NCT Number NCT07217496
Lead Sponsor ImmunityBio, Inc.
Conditions Metastatic Urothelial Carcinoma, Urothelial Carcinoma, Locally Advanced Urothelial Carcinoma, Urothelial Cancer, Bladder Cancer
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov