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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My bladder cancer has not responded to BCG treatment.
Select...
My bladder cancer has not responded to BCG treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease-Free Rate
Secondary outcome measures
Complete Response
Response
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
~30
Find a Location
Who is running the clinical trial?
ImmunityBio, Inc.Lead Sponsor
63 Previous Clinical Trials
4,946 Total Patients Enrolled
Karim Chamie, MDPrincipal InvestigatorUniversity of California, Los Angeles
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood test results show low levels of white blood cells or platelets.My liver enzymes are more than twice the normal limit.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.I do not have uncontrollable brain or nervous system disease.You are not expected to live for more than 2 years.You are not taking any other experimental medications at the same time.I have had bladder cancer or another cancer in the last 5 years that is getting worse or needs treatment, except for certain skin cancers, early-stage cancers in remission, or stable prostate cancer.I have severe heart failure or symptoms showing my heart isn't working well.I am currently on IV antibiotics for an infection.I am not pregnant or nursing, using birth control, and agree to continue during the study.My bladder cancer is confirmed to be high-grade and not muscle-invasive.My bladder cancer has not responded to BCG treatment.My bladder cancer has not responded to BCG treatment.I have not had a severe heart attack or unstable chest pain in the last 6 months.My bladder cancer returned after BCG treatment more than 6 months ago.I do not have a fever, UTI, tuberculosis, low blood pressure, or severe allergic reactions currently.I am on a daily steroid treatment higher than 10 mg of prednisone or its equivalent.I am 18 years old or older.My kidney function is low, with creatinine levels more than three times the normal upper limit.I am not on any cancer treatments except for BCG, ALT-803, or supportive care.
Research Study Groups:
This trial has the following groups:- Group 1: BCG+N-803
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the precedent for N-803 and BCG research?
"Right now, there are a 20 active research studies being conducted on N-803 and BCG. Out of those 20, 3 are in Phase 3. However, the majority of clinical trials taking place for N-803 and BCG are being conducted in Ann Arbor, Michigan. In total, there are 508 medical research sites running these sorts of experiments."
Answered by AI
Could you tell me how many different facilities are coordinating this research project?
"The primary locations for this clinical trial are UCLA Department of Urology in Los Angeles, California, Moffitt Cancer Center in Tampa, Florida, and Karmanos Cancer Institute in Detroit, New york. There are also 15 other locations participating in this trial."
Answered by AI
Are people with the specified medical condition still being recruited for this research project?
"That is accurate. The listing on clinicaltrials.gov currently states that the trial is looking for 200 individuals to participate. The trial was first posted on 6/2/2017 and the most recent update was on 10/26/2022. There will be 15 sites enrolling patients."
Answered by AI
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