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

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What is this study about?

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.

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

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

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)

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Studienpraxis Urologie Susan Feyerabend MD Tilman Todenhoefer MD PhD GbR Nuertingen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
17.06.2025

Trial locations

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.

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.

Trial ID:
2025-521223-78-00
Protocol code:
QUILT-2.005
NCT ID:
NCT02138734
Trial Phase:
Therapeutic exploratory (Phase II)

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