N-803 + BCG for Bladder Cancer
Trial Summary
What is the purpose of this trial?
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.
Research Team
Karim Chamie, MD
Principal Investigator
University of California, Los Angeles
Eligibility Criteria
Adults over 18 with high-grade non-muscle invasive bladder cancer unresponsive to BCG treatment can join. They must have had specific prior treatments, no resectable disease after surgery, and an ECOG status of 0-2. Exclusions include life expectancy under 2 years, certain heart conditions, active infections or recent severe infections, ongoing steroid therapy above a set dose, other cancer treatments or investigational drugs (excluding COVID-19), serious medical or psychiatric issues that could affect participation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Induction Treatment
Participants receive BCG plus N-803 or N-803 only weekly for 6 consecutive weeks
Second Treatment Period
Eligible patients receive either a 3-week maintenance course or a 6-week re-induction course at Month 3
Third Treatment Period
Eligible patients continue to receive maintenance treatment at Months 6, 9, 12, and 18
Fourth Treatment Period (Optional)
Eligible patients have the option to receive maintenance treatment at Months 24, 30, and 36
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BCG
- N-803
BCG is already approved in United States, European Union, Canada for the following indications:
- Non-muscle invasive bladder cancer
- Non-muscle invasive bladder cancer
- Non-muscle invasive bladder cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
ImmunityBio, Inc.
Lead Sponsor
Richard Adcock
ImmunityBio, Inc.
Chief Executive Officer since 2024
Information not available
Dr. Patrick Soon-Shiong
ImmunityBio, Inc.
Chief Medical Officer since 2021
MD