Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT03022825 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.
QUILT-3.032: A Multicenter Clinical Trial of Intravesical Bacillus Calmette-Guerin (BCG) in Combination With ALT-803 (N-803) in Patients With BCG Unresponsive High Grade Non-Muscle Invasive Bladder Cancer
Minor4 versionsRe-verified since May 13, 2025, no change to tracked fieldsv33-v36
MinorPrimary completion date changed from estimate of Apr 1, 2025 to Oct 1, 2024Completion date: Oct 1, 2028 to Mar 1, 2029 · Study sites revised (28)v32Show 2 more changesShow less
MinorTrial status: Recruiting to Active, Not RecruitingStudy sites: 32 to 28v31Show 1 more changeShow less
Study sites: 32 to 28
NotablePrimary completion date: Jul 2023 to Apr 1, 2025Completion date: Jul 2024 to Oct 1, 2028 · Site details revised at 3 of 32 sitesv30Show 2 more changesShow less
Completion date: Jul 2024 to Oct 1, 2028
Site details revised at 3 of 32 sites
MinorEnrollment target: 200 to 190Site details revised at 5 of 32 sitesv29Show 1 more changeShow less
Site details revised at 5 of 32 sites
Show 27 earlier versionsHide 27 earlier versions
MinorPrimary completion date: Jan 2023 to Jul 2023Completion date: Jan 2023 to Jul 2024 · Site details revised at 1 of 32 sitesv28Show 2 more changesShow less
MinorEnrollment target: 180 to 200Eligibility criteria expanded, about 35 words · Secondary endpoints: details revised at 2 of 7 entries · Study title expanded, about 1 wordv22Show 3 more changesShow less
Eligibility criteria expanded, about 35 words
Secondary endpoints: details revised at 2 of 7 entries
MinorEnrollment target: 183 to 180Study sites: 30 to 32 · Interventions: ALT-803 (Drug), ALT-803 and BCG (Drug) to N-803 (Drug), N-803 and BCG (Drug)v21Show 2 more changesShow less
Study sites: 30 to 32
Interventions: ALT-803 (Drug), ALT-803 and BCG (Drug) to N-803 (Drug), N-803 and BCG (Drug)
NotableLead sponsor: Altor BioScience to ImmunityBio, Inc.v20
NotablePhase: Phase 2 to Phase 2/3Site details revised at 4 of 30 sitesv19Show 1 more changeShow less
Site details revised at 4 of 30 sites
Minor2 versionsRe-verified since Aug 14, 2020, no change to tracked fieldsv17-v18
MinorEnrollment target: 160 to 183Interventions: ALT-803 (Drug), ALT-803 (Drug), BCG (Drug) to ALT-803 (Drug), ALT-803 and BCG (Drug)v16Show 1 more changeShow less
Interventions: ALT-803 (Drug), ALT-803 (Drug), BCG (Drug) to ALT-803 (Drug), ALT-803 and BCG (Drug)
NotablePrimary completion date: Dec 2019 to Jan 2023Completion date: Sep 2020 to Jan 2023 · Interventions: ALT-803 (Drug), BCG (Drug) to ALT-803 (Drug), ALT-803 (Drug), BCG (Drug) · Secondary endpoints: details revised at 7 of 7 entries · 2 morev15Show 5 more changesShow less
NotablePrimary completion date: Mar 2019 to Dec 2019Site details revised at 2 of 31 sitesv13Show 1 more changeShow less
Site details revised at 2 of 31 sites
MinorSite contacts updated at 1 of 31 sitesv12
NotableEnrollment target: 100 to 160Primary endpoints: 1 to 2 · Eligibility criteria expanded, about 43 words · Secondary endpoints: 11 to 7 · 1 morev11Show 4 more changesShow less
NotablePhase: Phase 2/3 to Phase 2Study sites: 14 to 26 · Eligibility criteria expanded, about 114 words · Secondary endpoints: 8 to 9v8Show 3 more changesShow less
NotableTrial status: Not Yet Recruiting to RecruitingPrimary completion date: Feb 2019 to Mar 2019 · Completion date: Aug 2020 to Sep 2020 · Start date changed from estimate of May 2017 to Jun 2, 2017 · 1 morev4Show 4 more changesShow less
Primary completion date: Feb 2019 to Mar 2019
Completion date: Aug 2020 to Sep 2020
Start date changed from estimate of May 2017 to Jun 2, 2017
Site details revised at 2 of 2 sites
NotableStart date: Mar 2017 to May 2017Enrollment target: 80 to 100 · Study sites: 1 to 2 · Primary completion date: Dec 2018 to Feb 2019 · 3 morev3Show 6 more changesShow less
MinorInterventions: ALT-803 (Drug) to ALT-803 (Drug), BCG (Drug)v2
MinorStudy 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.
This is a Phase II/III, open-label, single-arm, multicenter study of intravesical BCG plus N-803 or N-803 only in patients with BCG unresponsive high grade non-muscle invasive bladder cancer (NMIBC). All patients treated in the study will receive via a urinary catheter in the bladder, BCG plus N-803 or N-803 only weekly for 6 consecutive weeks (initial induction treatment period). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients have the option to receive maintenance treatment in the fourth treatment period at Months 24, 30, and 36. The study duration is 60 months.