Follow up of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: Subjects who were enrolled and completed treatment with intravesical N-803 plus BCG in QUILT-2.005 phase 1b.

Trial locations and contacts

1 site in 1 country.

About this study

Official title: QUILT-205: Long-Term Follow-Up of Subjects in QUILT-2.005 Phase 1b Trial of Intravesical N-803 Plus BCG in BCG-Naive Non-Muscle Invasive Bladder Cancer (NMIBC)

Conditions

Non Muscle Invasive Bladder Cancer

Being tested

N803 plus Bacillus Calmette-Guerin (BCG)

Medical subject headings

Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• N803 plus Bacillus Calmette-Guerin (BCG)Drug

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Obtain Long Term Follow-Up data to be summarized using descriptive statistics

   Follow-up data on survival status, bladder cancer status (high-grade or low-grade), cystoscopy results (including number of cystoscopies done for each subject), biopsy results, upper tract evaluations, posttherapies and responses and outcomes of posttherapies, urine cytology results, and other medical history or treatments (if available) related to bladder cancer will be collected from subjects who were enrolled and treated in QUILT-2.005 phase 1b study with intravesical N-803 plus BCG.

   Study endpoints will be summarized with descriptive statistics. Continuous variables will be summarized as mean, median, standard deviation, and minimum and maximum values. Categorical variables will be summarized as the number and percentage of subjects in each category. All confidence intervals will be constructed at the two-sided 95% level of confidence.

   Measured: assessed up to 60 months

2. Assess the Complete response yearly

   CR rate yearly following completion of QUILT-2.005 phase 1b for subjects with CIS disease with or without papillary disease at the initial diagnosis.

   CR rate (as determined by the Investigator) yearly following completion of QUILT-2.005 phase 1b will be reported along with a two-sided exact 95% confidence interval. The exact confidence interval will be calculated using the Clopper-Pearson method.

   Measured: assessed up to 60 months

3. Asses Disease-free Survival

   To assess disease-free survival (DFS) since the first instillation of BCG plus N-803 in QUILT-2.005 phase 1b for subjects with papillary disease only at the initial diagnosis.

   DFS (as determined by the Investigator) will be analyzed using Kaplan-Meier (KM) analysis methods. Subjects that are disease-free at the end of follow-up with censored at the last disease-free assessment

   Measured: assessed up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted8 Aug 2023
2. Study start17 Aug 2023
3. Primary completion30 Aug 2033 (estimated)
4. Study completion30 Aug 2033 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Non Muscle Invasive Bladder CancerStudies of the same condition, open and under way.
• More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.