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Cancer Vaccine

N-803 + BCG for Bladder Cancer

Phase 2 & 3
Waitlist Available
Led By Karim Chamie, MD
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Histologic confirmation of non-muscle invasive bladder cancer of the transitional cell carcinoma high-grade subtype (mixed histology tumors allowed if transitional cell histology is predominant histology)
Must not have
Liver function abnormalities as indicated by ongoing hepatic enzyme elevation (AST or ALT) >2 times upper limit of normal (ULN)
History or evidence of uncontrollable central nervous system (CNS) disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug, N-803, for people with bladder cancer that has not responded to BCG treatment. Patients will receive the new drug through a urinary catheter weekly for 6 weeks, followed by maintenance treatment every 3 or 6 weeks for up to 3 years.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from the interventions might include irritation in the bladder area due to catheter use and immune-related reactions because of N-803's action on the body's defense system. Specific side effects are not listed but generally align with those expected from immunotherapy agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My bladder cancer is confirmed to be high-grade and not muscle-invasive.
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My bladder cancer has not responded to BCG treatment.
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My bladder cancer has not responded to BCG treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver enzymes are more than twice the normal limit.
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I do not have uncontrollable brain or nervous system disease.
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I have severe heart failure or symptoms showing my heart isn't working well.
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I have not had a severe heart attack or unstable chest pain in the last 6 months.
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I am currently on IV antibiotics for an infection.
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I do not have a fever, UTI, tuberculosis, low blood pressure, or severe allergic reactions currently.
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I am on a daily steroid treatment higher than 10 mg of prednisone or its equivalent.
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My kidney function is low, with creatinine levels more than three times the normal upper limit.
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I am not on any cancer treatments except for BCG, ALT-803, or supportive care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease-Free Rate
Secondary study objectives
Complete Response
Response

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: BCG+N-803Experimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
66 Previous Clinical Trials
4,569 Total Patients Enrolled
Karim Chamie, MDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

BCG (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03022825 — Phase 2 & 3
Bladder Cancer Research Study Groups: BCG+N-803
Bladder Cancer Clinical Trial 2023: BCG Highlights & Side Effects. Trial Name: NCT03022825 — Phase 2 & 3
BCG (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03022825 — Phase 2 & 3
~8 spots leftby Apr 2025
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