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A Study of Intravesical BCG in Combination With ALT-803 in Patients With Non-Muscle Invasive Bladder Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 31, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Enrollment reduced: 596 → 369 participants Primary completion moved earlier from Dec 2028 to Sep 30, 2026 · Trial status changed: Recruiting → Active, Not Recruiting · Completion pushed from Dec 2038 to Mar 4, 2039 · 2 morev48 Show 5 more changesShow less
    • Primary completion moved earlier from Dec 2028 to Sep 30, 2026
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Completion pushed from Dec 2038 to Mar 4, 2039
    • Interventions: BCG( 50mg/Instillation) (Biological), BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). ) (Biological) to BCG (50mg/instillation) (Biological), BCG (50mg/instillation) + N-803 (400 μg/instillation) (Biological)
    • Site details revised at 108 of 108 sites
  2. Study sites: 80 to 108v47
  3. Re-verified, no change to tracked fieldsv46
  4. Study sites: 60 to 80v45
  5. Study sites: 25 to 60v44
Show 42 earlier versionsHide 42 earlier versions
  1. Secondary endpoints revised (14)v43 See this version in full on ClinicalTrials.gov ↗
  2. Secondary endpoints revised (14)v42 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 24 to 25 Interventions: BCG (Biological), BCG+N-803 (Biological) to BCG( 50mg/Instillation) (Biological), BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). ) (Biological) · Eligibility criteria expanded, about 14 words · Secondary endpoints: 6 to 14v41 Show 3 more changesShow less
    • Interventions: BCG (Biological), BCG+N-803 (Biological) to BCG( 50mg/Instillation) (Biological), BCG+N-803( 50mg BCG/ Instillation+ N-803( 400 μg/instillation). ) (Biological)
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: 6 to 14

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Dec 2025 to Dec 2028 Completion date: Dec 2027 to Dec 2038v40 Show 1 more changeShow less
    • Completion date: Dec 2027 to Dec 2038
  5. Eligibility criteria expanded, about 25 words Secondary endpoints: details revised at 6 of 6 entries · Site details revised at 5 of 24 sitesv39 Show 2 more changesShow less
    • Secondary endpoints: details revised at 6 of 6 entries
    • Site details revised at 5 of 24 sites

    See this version in full on ClinicalTrials.gov ↗

  6. Re-verified, no change to tracked fieldsv38
  7. Site details revised at 5 of 24 sitesv37
  8. Site details revised at 7 of 24 sitesv36
  9. Site contacts updated at 1 of 24 sitesv35
  10. Re-verified, no change to tracked fieldsv34
  11. Site details revised at 3 of 24 sitesv33
  12. Eligibility criteria expanded, about 22 words Site details revised at 6 of 24 sitesv32 Show 1 more changeShow less
    • Site details revised at 6 of 24 sites

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 23 to 24 Interventions: BCG (Biological), BCG+ALT-803 (Biological) to BCG (Biological), BCG+N-803 (Biological) · Study description revisedv31 Show 2 more changesShow less
    • Interventions: BCG (Biological), BCG+ALT-803 (Biological) to BCG (Biological), BCG+N-803 (Biological)
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  14. Site details revised at 1 of 23 sitesv30
  15. Lead sponsor: Altor BioScience to ImmunityBio, Inc.v29
  16. Re-verified, no change to tracked fieldsv28
  17. Study sites: 22 to 23v27
  18. Primary completion date: Jul 2021 to Dec 2025 Completion date: Oct 2021 to Dec 2027v26 Show 1 more changeShow less
    • Completion date: Oct 2021 to Dec 2027
  19. Study sites: 21 to 22v25
  20. Study sites: 20 to 21v24
  21. Study sites: 19 to 20v23
  22. Study sites: 18 to 19v22
  23. Site details revised at 2 of 18 sitesv21
  24. Study sites: 16 to 18v20
  25. Study sites: 14 to 16v19
  26. Site details revised at 1 of 14 sitesv18
  27. Site details revised at 1 of 14 sitesv17
  28. Site details revised at 1 of 14 sitesv16
  29. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 256 to 596 · Primary completion date: Jul 2019 to Jul 2021 · Primary endpoints: 4 to 2 · 6 morev15 Show 9 more changesShow less
    • Enrollment target: 256 to 596
    • Primary completion date: Jul 2019 to Jul 2021
    • Primary endpoints: 4 to 2
    • Completion date: Oct 2019 to Oct 2021
    • Start date: Jul 2014 to Jul 21, 2014
    • Eligibility criteria expanded, about 334 words
    • Secondary endpoints: 7 to 6
    • Site details revised at 14 of 14 sites
    • Study description shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  30. Trial status: Recruiting to Active, Not Recruiting Site details revised at 14 of 14 sitesv14 Show 1 more changeShow less
    • Site details revised at 14 of 14 sites
  31. Enrollment target: 81 to 256 Primary completion date: Jul 2018 to Jul 2019 · Primary endpoints: 2 to 4 · Study sites: 15 to 14 · 5 morev13 Show 8 more changesShow less
    • Primary completion date: Jul 2018 to Jul 2019
    • Primary endpoints: 2 to 4
    • Study sites: 15 to 14
    • Completion date: Oct 2018 to Oct 2019
    • Eligibility criteria expanded, about 46 words
    • Secondary endpoints revised (7)
    • Study description shortened, about 9 words
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  32. Study sites: 13 to 15v12
  33. Study sites: 7 to 13v11
  34. Study title shortened, about 1 wordv10 See this version in full on ClinicalTrials.gov ↗
  35. Enrollment target: 115 to 81 Eligibility criteria shortened, about 30 words · Secondary endpoints: details revised at 1 of 7 entries · Study description shortened, about 24 words · 1 morev9 Show 4 more changesShow less
    • Eligibility criteria shortened, about 30 words
    • Secondary endpoints: details revised at 1 of 7 entries
    • Study description shortened, about 24 words
    • Study arms: 4 to 2

    See this version in full on ClinicalTrials.gov ↗

  36. Site contacts updated at 3 of 7 sitesv8
  37. Study sites: 6 to 7v7
  38. Study sites: 4 to 6v6
  39. Enrollment target: 18 to 115 Interventions: ALT-803 (Biological) to BCG (Biological), BCG+ALT-803 (Biological) · Eligibility criteria expanded, about 36 words · Study description expanded, about 27 words · 3 morev5 Show 6 more changesShow less
    • Interventions: ALT-803 (Biological) to BCG (Biological), BCG+ALT-803 (Biological)
    • Eligibility criteria expanded, about 36 words
    • Study description expanded, about 27 words
    • Site contacts updated at 1 of 4 sites
    • Study arms: 1 to 4
    • Study title shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  40. Study sites: 1 to 4v4
  41. Re-verified, no change to tracked fieldsv3
  42. Trial status: Not Yet Recruiting to Recruiting Start date: May 2014 to Jul 2014 · Primary completion date: May 2018 to Jul 2018 · Completion date: Aug 2018 to Oct 2018 · 1 morev2 Show 4 more changesShow less
    • Start date: May 2014 to Jul 2014
    • Primary completion date: May 2018 to Jul 2018
    • Completion date: Aug 2018 to Oct 2018
    • Site details revised
  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.
ImmunityBio, Inc.
33 trials monitored
See 2 trials at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
This is a Phase Ib/IIb, randomized, two-cohort, open-label, multicenter study of intravesical N-803 plus BCG versus BCG alone, in BCG naïve patients with high-grade NMIBC.
Trial Details
NCT Number NCT02138734
Lead Sponsor ImmunityBio, Inc.
Conditions Non-muscle Invasive Bladder Cancer
Enrollment 369 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov