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Trial Title:
Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)
NCT ID:
NCT05981131
Condition:
Non Muscle Invasive Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Non-Muscle Invasive Bladder Neoplasms
BCG Vaccine
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
N803 plus Bacillus Calmette-Guerin (BCG)
Description:
QUILT-2.005 phase 1b (NCT02138734) was an open-label, dose-escalation, multicenter study
of intravesical Bacillus Calmette-Guerin (BCG) plus N-803 in BCG-naïve non muscle
invasive bladder cancer (NMIBC). A modified 3 + 3 design was used. Three subjects were
enrolled at each dose level starting at 100 μg/instillation of N-803 and subsequently
increasing to 200 μg/instillation and 400 μg/instillation. A standard dose of BCG, 50 mg,
was employed. The primary endpoints of the study were: determination of the maximum
tolerated dose (MTD) and designation of the recommended dose (RD) of N-803 in combination
with BCG in subjects who have BCG-naïve NMIBC; safety profile of N-803 plus BCG in
treated subjects; and disease response rate in treated subjects. A total of 9 subjects
with high-risk, high-grade, BCG-naïve, NMIBC were enrolled into 3 cohorts and treated by
intravesical administration of N-803 plus BCG.
Summary:
The purpose of this clinical trial is to obtain long-term follow-up information and
status of bladder cancer for patients who received study treatment in the QUILT-2.005
study.
Detailed description:
All 9 subjects that completed QUILT-2.005 phase 1b are planned to be enrolled in this
study.
Thus, the maximum enrollment for this study is 9 subjects. All enrolled subjects will be
followed every 12 months for life, or until withdrawal of consent, or if the Sponsor
closes the study.
Criteria for eligibility:
Study pop:
Subjects who were enrolled and completed treatment with intravesical N-803 plus BCG in
QUILT-2.005 phase 1b.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Enrolled and treated with intravesical N-803 plus BCG in the phase 1b portion of
QUILT-2.005.
Exclusion Criteria:
- Not applicable
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Island Urology
Address:
City:
Honolulu
Zip:
96813
Country:
United States
Start date:
August 17, 2023
Completion date:
August 30, 2033
Lead sponsor:
Agency:
ImmunityBio, Inc.
Agency class:
Industry
Source:
ImmunityBio, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05981131
