Not recruiting

Study of N-803 combined with BCG treatment for patients with early-stage bladder cancer that has not invaded the muscle wall

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Non-Muscle Invasive Bladder Cancer, an early-stage cancer that affects the inner lining of the bladder without spreading to the muscle layer. The research evaluates a combination treatment using two medications: N-803 (also known as nogapendekin alfa inbakicept) and BCG (Bacillus Calmette-Guérin). BCG is an established treatment that helps stimulate the immune system to fight bladder cancer cells, while N-803 is a new medication being tested to enhance the effectiveness of BCG treatment.

The purpose of this research is to determine if combining N-803 with BCG works better than using BCG alone for treating early-stage bladder cancer. The study includes two groups of patients: those with a type of bladder cancer called carcinoma in situ (CIS) and those with high-grade papillary disease. Both medications are given directly into the bladder through a process called intravesical administration.

The treatment period lasts for 37 months, during which patients receive either the combination of N-803 and BCG or BCG alone. Throughout the study, doctors monitor the patients' response to treatment using various examination methods to check if the cancer has responded to therapy or if it has returned. Regular check-ups include examining the bladder and collecting urine samples to test for cancer cells.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment preparation
Your participation begins after confirming you have non-muscle invasive bladder cancer
Medical tests will be performed, including blood tests and kidney function assessment
A cystoscopy examination and bladder biopsy must be completed within 90 days before treatment starts
Step 2
Treatment assignment
You will be placed in one of two groups:
Cohort A: If you have CIS (carcinoma in situ) disease
Cohort B: If you have high-grade papillary disease
Step 3
Medication administration
You will receive either a combination of two medications or a single medication:
- N-803 (nogapendekin alfa inbakicept) plus BCG (bacillus calmette-guérin), or
- BCG alone
Both medications will be administered directly into the bladder (intravesical use)
Step 4
Follow-up evaluations
Regular check-ups will occur at 3, 6, 9, 12, 18, 24, 30, and 36 months
Each follow-up includes:
- Cystoscopy examination
- Urine tests
- Additional bladder biopsy if required
Step 5
Treatment monitoring
Your response to treatment will be evaluated based on your assigned group:
Cohort A: Complete response will be assessed at 6 months
Cohort B: Disease-free survival will be monitored throughout the study

Who can join the trial?

16 criteria

Must have confirmed non-muscle invasive bladder cancer (cancer that has not spread to the muscle layer of the bladder) diagnosed within the last 3 months
Must be at least 18 years old
Must be able to perform daily activities with minimal assistance (ECOG performance status of 0-2)
Must be either:
- Never treated with BCG therapy (a type of bladder treatment), or
- Last BCG treatment was more than 3 years ago
- Must have acceptable blood test results including:
  - Normal lymphocyte count (white blood cells)
  - Adequate neutrophil count (type of white blood cells)
  - Adequate platelet count
  - Adequate hemoglobin level (oxygen-carrying protein)
  - Acceptable kidney function
  - Acceptable liver function
  - Must have adequate lung function
  - For women who can become pregnant:
    
    Must have a negative pregnancy test
    Must use approved birth control methods during the study
    For men: must use barrier methods of birth control during the study
    Must be willing to sign informed consent and follow study procedures

Who cannot join the trial?

13 criteria

History of muscle-invasive bladder cancer (cancer that has grown into the muscle layer of the bladder wall)
Current urinary tract infection or other active infection requiring treatment
Previous treatment with BCG therapy (a type of immunotherapy used to treat bladder cancer) that failed
Known allergic reactions to BCG or other medications used in the study
Active or untreated tuberculosis
Presence of other types of cancer that require treatment
Severe medical conditions that could interfere with study participation
Pregnancy or breastfeeding
Current participation in other clinical trials
Immunosuppression (weakened immune system) due to medication or medical conditions
Major surgery within 4 weeks before starting the study
Mental conditions that could affect ability to follow study procedures
History of serious allergic reactions to medical treatments

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Verified sites

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Verified
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR
Nuertingen, Germany

Trial locations

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Investigated drugs

BCG (Bacillus Calmette-Guerin)
is a type of bacteria used as an immunotherapy treatment. When placed directly into the bladder, it helps stimulate the immune system to fight bladder cancer cells. It's commonly used to treat non-muscle invasive bladder cancer and helps prevent the cancer from returning or progressing.
N-803 (ALT-803)
is an experimental immunotherapy drug designed to enhance the body's natural immune response. When combined with BCG, it may help improve the effectiveness of treatment for bladder cancer by stimulating immune cells to better recognize and attack cancer cells.

What is already known about the treatment

Bacillus Calmette-Guerin (BCG)
A live attenuated bacterial immunotherapy administered directly into the bladder through a catheter (intravesical administration) for treating non-muscle invasive bladder cancer. This well-established treatment works by stimulating the immune system to attack cancer cells in the bladder lining, making it particularly effective for early-stage bladder tumors and carcinoma in situ. BCG is classified as a biological response modifier and remains the gold standard treatment for high-risk non-muscle invasive bladder cancer, with decades of clinical evidence supporting its use.
N-803 (ALT-803)
An investigational immunotherapeutic agent administered intravesically in combination with BCG for treating non-muscle invasive bladder cancer. This novel biological response modifier works by enhancing natural killer cell and T-cell activity to strengthen the immune response against cancer cells. N-803 is being studied in clinical trials to determine if it can improve the effectiveness of standard BCG therapy, particularly in patients with carcinoma in situ or high-grade papillary disease.

Investigated diseases

Non-Muscle Invasive Bladder Cancer – A type of bladder cancer that affects the inner lining of the bladder without penetrating into the muscle layer. The cancer begins in the cells that line the bladder's inner surface and may appear as small growths or flat patches. It can occur in different forms, including carcinoma in situ (CIS) and papillary tumors (Ta/T1). The disease may develop in multiple areas of the bladder at the same time. Over time, the cancer cells can multiply and spread across the bladder's lining. This condition primarily affects the superficial layers of the bladder wall.