Study on BCG and N-803 Combination Therapy for Patients with High-Grade Non-Muscle Invasive Bladder Cancer
Sponsor: ImmunityBio, Inc.
ClinicalTrials ID:NCT03022825
This clinical trial is testing a combination of BCG and N-803 treatments for patients with high-grade non-muscle invasive bladder cancer that has not responded to previous BCG therapy. The study aims to determine if this combination can effectively manage the cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring a treatment for patients with high-grade non-muscle invasive bladder cancer that hasn't responded to BCG therapy. Participants will receive BCG and N-803, or N-803 alone, directly into the bladder through a catheter. The treatment is given weekly for six weeks initially. Depending on the response, patients may receive additional treatment courses at 3, 6, 9, 12, 18, 24, 30, and 36 months. The study will last up to 60 months.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older.
- Diagnosed with high-grade non-muscle invasive bladder cancer, specifically transitional cell carcinoma.
- Cancer that hasn't responded to previous BCG treatment, defined by specific criteria related to the timing and type of cancer recurrence.
- No remaining cancer that can be surgically removed after initial procedures, except for certain types of cancer.
- Good overall health with an ECOG performance status of 0, 1, or 2.
- Willing to provide written consent and follow study procedures.
Exclusion Criteria
- Cancer recurrence beyond specific time frames after last BCG treatment.
- Life expectancy of less than 2 years.
- Certain low blood cell counts or liver and kidney function issues.
- History of more advanced bladder cancer or other cancers within the last 5 years, with some exceptions.
- Severe heart conditions or recent heart attack.
- Uncontrolled brain or nervous system issues.
- Active infections requiring treatment or recent serious infections.
- Use of systemic steroids above a certain dose.
- Pregnant or nursing women, or those not using effective birth control.
- Currently receiving other cancer treatments or investigational drugs.
- Any other condition that the study doctor believes would interfere with participation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Alaska Clinical Research Center | 99503 | Anchorage | Alaska |
| Arkansas Urology | 72211 | Little Rock | Arkansas |
| UCLA Department of Urology | 90024 | Los Angeles | California |
| Hoag Memorial Hospital | 92663 | Newport Beach | California |
| Skyline Urology | 91411 | Sherman Oaks | California |
| Skyline Urology | 90505 | Torrance | California |
| Urology Associates, PC | 80113 | Englewood | Colorado |
| University of Miami Miller School of Medicine-Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
| Clinical Research Center of Florida | 33060 | Pompano Beach | Florida |
| Moffitt Cancer Center | 33612 | Tampa | Florida |
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