N-803 + BCG for Bladder Cancer

Recruiting in Palo Alto (17 mi)

+28 other locations

Karim Chamie, MD - Minimally Invasive ...

Overseen ByKarim Chamie, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: ImmunityBio, Inc.

No Placebo Group

Prior Safety Data

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.

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

My bladder cancer cannot be removed by surgery, but I've had all necessary resections.

I can take care of myself and am up and about more than half of my waking hours.

Voluntary written informed consent and HIPAA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

+4 more

Exclusion Criteria

Your blood test results show low levels of white blood cells or platelets.

My liver enzymes are more than twice the normal limit.

I do not have uncontrollable brain or nervous system disease.

+13 more

Participant Groups

The trial is testing the effectiveness of intravesical BCG combined with N-803 versus N-803 alone in treating bladder cancer that hasn't responded to previous BCG therapy. Patients receive these treatments through a urinary catheter for six weeks initially and may continue maintenance treatment at various intervals up to three years if eligible.

1Treatment groups

Experimental Treatment

Group I: BCG+N-803Experimental Treatment2 Interventions

BCG is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Bacillus Calmette-Guérin for: