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

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non Muscle Invasive Bladder Cancer
• Intervention / Treatment: Drug: N803 plus Bacillus Calmette-Guerin (BCG)

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.

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Island Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Enrolled and treated with intravesical N-803 plus BCG in the phase 1b portion of QUILT-2.005.

Exclusion Criteria:

• Not applicable

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	assessed up to 60 months
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.	assessed up to 60 months
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	assessed up to 60 months

Collaborators and Investigators

• Sponsor: ImmunityBio, Inc.
• Investigators: Study Director: Bobby Reddy, MD, ImmunityBio, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2023
• Primary Completion (Estimated): August 30, 2033
• Study Completion (Estimated): August 30, 2033

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Estimated): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Urinary Bladder Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Bladder Neoplasms; Non-Muscle Invasive Bladder Neoplasms; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; BCG Vaccine
• Other Study ID Numbers: QUILT-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No