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Cancer Vaccine

BCG + N-803 for Bladder Cancer

Phase 1 & 2
Recruiting
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
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
Symptomatic congestive heart failure (CHF), NYHA (New York Heart Association) Class III or IV or other clinical signs of severe cardiac dysfunction
Severe/unstable angina pectoris, or myocardial infarction within 6 months prior to study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years after treatment period visits
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new drug to treat bladder cancer. The new drug is being tested against the standard treatment to see if it is more effective.

Who is the study for?
This trial is for adults with high-grade non-muscle invasive bladder cancer who haven't had BCG treatment before. They should be in good enough health to undergo the therapy, with specific blood counts and organ functions within set limits. Women of childbearing age must use birth control, as must men, to prevent pregnancy during the study.
What is being tested?
The study compares two treatments: one group receives a combination of an immune response booster called N-803 plus BCG (a type of immunotherapy), while another group gets only BCG. It's designed to see if adding N-803 improves outcomes for patients who are new to this kind of treatment.
What are the potential side effects?
Potential side effects may include irritation or discomfort in the bladder area due to intravesical administration, flu-like symptoms from immune system activation by BCG or N-803, and typical risks associated with immunotherapies such as allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My bladder cancer is confirmed to be high-grade and not muscle-invasive.
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I had a biopsy and a cystoscopy showing no removable cancer within the last 3 and 6 weeks, respectively.
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I can care for myself and am up and about more than 50% of my waking hours.
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I am eligible for bladder treatment with BCG.
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My bladder cancer is confirmed and either in early stage or high-grade but not invasive.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe heart failure symptoms.
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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, TB, low blood pressure, or severe allergic reactions currently.
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I do not have uncontrolled brain or spinal cord disease.
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I have had BCG treatment or am allergic to it.
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I am on a daily steroid treatment of more than 10 mg of prednisone or its equivalent.
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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years after treatment period visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years after treatment period visits for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Response (CR) Rate
Disease Free Survival (DFS)
Secondary study objectives
Cohort B: Disease Free Survival
Cohort B: Disease Free Survival Rate
Complete Response Rate( All Recurrent Bladder Cancer Including Low Grade Ta Disease)
+11 more
Other study objectives
Exploratory Endpoints- Immunogenicity: Serum level of anti-N-803 in patient samples
Exploratory Endpoints- Whole Slide Images (Baseline and any on-study biopsy)
Quality of Life Endpoint

Awards & Highlights

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: N-803+BCGExperimental Treatment1 Intervention
(Phase Ib and IIb) for BCG-naive patients
Group II: BCG aloneActive Control1 Intervention
(Phase IIb) for BCG-naive patients

Find a Location

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
68 Previous Clinical Trials
3,738 Total Patients Enrolled
Chad Garner, PhDStudy DirectorImmunityBio, Inc.
3 Previous Clinical Trials
1,579 Total Patients Enrolled
Bobby Reddy, MDStudy DirectorImmunityBio, Inc.
4 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

ALT-803 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02138734 — Phase 1 & 2
Bladder Cancer Research Study Groups: BCG alone, N-803+BCG
Bladder Cancer Clinical Trial 2023: ALT-803 Highlights & Side Effects. Trial Name: NCT02138734 — Phase 1 & 2
ALT-803 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02138734 — Phase 1 & 2
~163 spots leftby Dec 2028
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