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Study of Nadofaragene Firadenovec for Adults with Intermediate Risk Non-Muscle Invasive Bladder Cancer

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a type of bladder cancer known as non-muscle invasive bladder cancer (NMIBC), specifically in patients who have an intermediate risk of the cancer returning or worsening. The treatment being tested is called nadofaragene firadenovec, also known by its code name ADSTILADRIN. This treatment is given as an intravesical suspension, which means it is administered directly into the bladder. The study aims to compare the effectiveness of this treatment with the standard practice of simply observing the patients without additional treatment.

The purpose of the study is to see if nadofaragene firadenovec can help prevent the cancer from coming back or getting worse. Participants in the study will receive the treatment every three months. The study will last for up to 24 months, during which time the health of the participants will be closely monitored. The main focus is on how long patients remain free from cancer recurrence, progression, or any cause of death during the study period.

Participants in the study will have already undergone a procedure called transurethral resection of the bladder tumor (TURBT), which is a common method for removing bladder tumors. The study will help determine if adding nadofaragene firadenovec to the treatment plan can improve outcomes for patients with intermediate risk NMIBC. The results of this study could provide valuable information on the potential benefits of this new treatment option for bladder cancer patients.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, written consent is required. This consent confirms understanding and agreement to participate in the trial.

    For female participants of childbearing potential, a negative pregnancy test is necessary within 72 hours before receiving the first dose of the investigational medicinal product.

  2. Step 2

    Initial treatment

    The treatment involves the administration of nadofaragene firadenovec, known by the product name ADSTILADRIN.

    This medication is given as an intravesical suspension, meaning it is delivered directly into the bladder.

    The treatment is administered every three months.

  3. Step 3

    Monitoring and follow-up

    Participants will be monitored for any recurrence or progression of bladder cancer, as well as overall health status.

    The primary goal is to assess the time until any recurrence, progression, or death from any cause over a 24-month period.

  4. Step 4

    End of treatment

    The trial is expected to continue until June 2031, with individual participation lasting up to 24 months.

    At the end of the treatment period, a final assessment will be conducted to evaluate the outcomes of the trial.

Who can join the trial?

19 criteria

  • Must be willing and able to provide written consent for the trial before any trial-related procedures.
  • Must be 18 years or older at the time of consent.
  • Must have intermediate risk, non-muscle invasive bladder cancer as defined by medical guidelines.
  • Must have had a complete transurethral resection of bladder tumor (TURBT) within 60 days before joining the study. This is a procedure to remove bladder tumors.
  • Must have a life expectancy of more than 2 years.
  • Must have a normal upper urinary tract as shown by tests like ultrasound or CT scan within 1 year before joining the study, and no tumor in the prostatic urethra.
  • Must have an ECOG status of 2 or less. This is a scale to measure how well you can perform daily activities.
  • Must have adequate laboratory values, which include:
    • Hemoglobin of at least 9 g/dL without needing a blood transfusion.
    • White blood cells of at least 4 x 109/L.
    • Absolute neutrophil count of at least 1.5 x 109/L.
    • Platelets of at least 75 x 109/L.
    • Normal blood clotting times unless on blood thinners.
    • Liver enzymes (AST and ALT) and bilirubin within normal limits.
    • Kidney function tests (creatinine clearance and eGFR) of at least 30 ml/min.
    • Must follow COVID-19 management and control policies applicable in your area.
    • Female participants of childbearing potential must have a negative pregnancy test before receiving the first dose of the study drug and use highly effective contraception during the study and for 6 months after the last dose.
    • Male participants with female partners of reproductive potential must be surgically sterile or use effective contraception during the study and for 3 months after the last dose.
    • Participants with prostate cancer that has been treated with radiation therapy are eligible if the treatment was completed at least 1 year before joining the study and they have remained disease-free.
    • Participants with prostate cancer on active surveillance at low risk for progression can join the study if their PSA is less than 10 ng/mL, Gleason score is 6, and cT1 stage, at the discretion of the investigator.

Who cannot join the trial?

3 criteria

  • Patients who have not undergone a procedure called transurethral resection of the bladder tumor (TURBT) within 60 days before joining the study. This is a surgery to remove bladder tumors.
  • Patients who have not received peri-operative intravesical chemotherapy within 60 days before joining the study. This is a treatment where chemotherapy is placed directly into the bladder around the time of surgery.
  • Patients who are part of a vulnerable population, which means groups of people who might need special protection or care.
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Investigated drugs

Nadofaragene Firadenovec is a type of gene therapy used in the treatment of bladder cancer. It works by delivering a specific gene into the cells of the bladder. This gene helps the body produce a protein that can fight cancer cells. In this clinical trial, the therapy is being tested to see if it can help prevent the return or worsening of bladder cancer in patients who have already had surgery to remove their tumors. The therapy is given every three months, and researchers are comparing its effectiveness to simply observing patients without additional treatment. The goal is to see if this therapy can extend the time before the cancer comes back or progresses, or if it can help patients live longer without the disease getting worse.

What is already known about the treatment

Nadofaragene Firadenovec – This medication is administered directly into the bladder through a catheter, a method known as intravesical therapy. It is currently being studied in clinical trials for its effectiveness in treating intermediate-risk, non-muscle invasive bladder cancer. The main therapeutic use of Nadofaragene Firadenovec is to prevent the recurrence or progression of bladder cancer after surgical removal of the tumor. At the molecular level, it works by delivering a gene into the bladder cells that helps stimulate the body's immune response to attack cancer cells. It is classified as a gene therapy, which is a type of treatment that uses genetic material to fight or prevent disease.

Investigated diseases

Intermediate risk non-muscle invasive bladder cancer – This type of bladder cancer is characterized by the presence of cancerous cells in the bladder lining that have not invaded the muscle layer. It is considered intermediate risk due to factors such as tumor size, number, and recurrence rate. The disease progresses as the cancer cells grow and potentially spread to other parts of the bladder lining. Over time, if not managed, it may lead to more aggressive forms of cancer. The progression is typically monitored through regular medical evaluations to detect any changes in the tumor's behavior.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512029-10-00Protocol code000423Estimated enrolment483 patientsSponsorFerring Pharmaceuticals A/S

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