Bladder Cancer
Bladder Cancer2
Bladder Cancer3
Bladder Cancer4

Websites for potential clinical study participants with bladder cancer

STUDY OVERVIEW

No treatments for intermediate risk, non muscle invasive bladder cancer (NMIBC) are currently approved by the FDA or any other health authority. This study is evaluating an investigational study drug called nadofaragene firadenovec in adults with intermediate risk NMIBC. Nadofaragene firadenovec is currently approved by the United States FDA under the tradename ADSTILADRIN® for the treatment of high risk NMIBC, that has not responded to Bacillus Calmette-Guérin (BCG) treatment. Clinical studies like this one aim to find new and better ways of preventing, and treating the disease. Being part of discovering new health information may help others in the future. This study is evaluating nadofaragene firadenovec to find out:

  • How effective the study drug is in preventing intermediate risk NMIBC from returning after removal.

  • How well tolerated the study drug is in preventing intermediate risk NMIBC from returning after removal.

WHO CAN JOIN?

To be eligible for this study, you must:

  • Be at least 18 years of age

  • NMIBC

    Be diagnosed with intermediate risk NMIBC

Get Started

This is not a complete list of study requirements. The study doctor will review the full requirements for this study with you.

WHAT WILL HAPPEN IF I TAKE PART?

1

If you are eligible to participate:

  • Your study doctor will first perform a transurethral resection of bladder tumor (TURBT) to remove the tissue from your bladder that could be cancer. After this procedure, you will be randomly assigned to one of the following two groups (arms) during the study: • Arm 1: receive nadofaragene firadenovec (study drug) • Arm 2: observation (no study drug; standard treatment)
  • Arm 1 participants will receive the study drug once every 3 months 
at the clinic visits during the 2-year study treatment period unless the cancer returns. The study drug will be given directly into the bladder through a urinary catheter.
  • Arm 2 participants will come to the clinic twice every 3 months during the first 2 years and will be provided standard treatment. If you are in Arm 2 and if your cancer returns within the first 2 years, you will be given the option of receiving the study drug once every 3 months at clinic visits for up to 2 years.
  • You will be in this study for up to 5 years, which includes a study treatment period (up to 2 years) and a follow-up period (up to 3 years).
  • Laboratory tests, cystoscopy (procedure to examine the bladder and urethra), heart tests, bladder biopsies, and other assessments and questionnaires will be conducted as part of this study (please see Assessments and Procedures in Frequently Asked Questions).

    • 2

    Screening Period (up to 2 months)

  • Written informed consent must be obtained prior to any trial-related procedures.
  • Eligible participants will undergo a cystoscopy and transurethral resection of bladder tumor (TURBT) with complete removal of all visible tumor
  • During the screening period there will be a number of additional assessments to check if you are eligible for the study, e.g. urinary symptoms, have blood and urine samples taken, check your medicines and health status.
  • This is not a complete list of screening procedures. The study doctor will review all screening procedures together with you and see if you are eligible to participate in the study.
  • Eligible participants will be randomized to treatment with study drug or observation.

    • 3

    Treatment Period (up to 2 years)

  • All participants (randomized to study drug or observation) will follow the same assessment schedule for 2 years and the status of the bladder cancer will be checked.
  • Participants randomized to study drug will receive the study drug 
once every 3 months directly into the bladder through a urinary catheter. Participants will get up to 8 doses during the study treatment period if their cancer does not return.
  • Participant will have clinic visits twice every 3 months for the first 2 years of the study.
  • The study staff may contact you by phone each month that you do not have a scheduled clinic visit. The study staff will review medications you are taking or have taken recently and ask questions about how you are feeling.
  • During the treatment period there will be different assessment and procedures performed (please see Assessments and Procedures in Frequently Asked Questions).
  • If you are randomized to the observation arm and your cancer has returned within the first 2 years, you will be given the option of receiving the study drug for up to 2 years.
  • If your bladder cancer returns, you will stop receiving the study drug.

    • 4

    Follow-up Period (up to 3 years)

  • During this period, the study staff will collect information every 6 month to assess your bladder cancer and overall health and well-being.
  • If you were randomized to the observation arm and later received optional study drug, you will still complete the study after 5 years (ie, the follow-up period may be shorter for you).

    • 5

    Annual Phone Calls

  • If your bladder cancer returns at any time during the study treatment period or during the follow-up period, you will stop receiving the study drug and related visits. Your doctor will discuss treatment options with you. You will then be contacted by phone once a year up to year 5.

    • FREQUENTLY ASKED QUESTIONS

    What is a clinical study?

    A clinical study is a research study involving volunteers (also called participants) that is intended to add to medical knowledge of a disease or condition, in this case, bladder cancer.

    What is a study drug? What is ADSTILADRIN® (the study drug)?

    A study drug contains a substance that is being tested in clinical studies. Every study drug is reviewed by a government health authority, such as the United States Food and Drug Administration (FDA), and an ethics committee for testing in people. The study drug in this study, nadofaragene firadenovec, has been approved by the United States FDA under the tradename ADSTILADRIN® for the treatment of high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC).

    Why is the ABLE-32 study important?

    No treatments for intermediate risk NMIBC are currently approved by the FDA or any other health authority. Clinical studies like this one can add to medical knowledge as scientists try to find new and better ways to treat diseases. Being part of discovering new health information may help others in the future.

    What is the purpose of this study?

    The purpose of this study is to evaluate how effective and how well tolerated the study drug in comparison to observation, meaning a surveillance of whether the cancer returns during the study period.

    Who can participate in the ABLE-32 study?

    To be eligible for this study, you must: • Be at least 18 years of age • Be diagnosed with intermediate risk NMIBC This is not a complete list of study requirements. The study doctor will review the full requirements with you.

    How long will this study last?

    You will be in this study for up to 5 years, which includes a study treatment period (up to 2 years) and a follow-up period (3 years).

    What types of assessments and procedures may be included?

    The following is a list of assessments and procedures that will be performed at some point during participation in this study. Bladder biopsy : A small sample of tumor tissue (biopsy) may be taken in this study to assess cancer recurrence or progression. Cystoscopy : A procedure that examines the lining of your bladder and urethra, the tube that carries urine out of your body. Before the procedure, you will receive general anesthesia or a local anesthetic jelly to numb your urethra. During this procedure, a cystoscope (hollow tube) with an attached camera inserted into your urethra and slowly advanced into your bladder. Daily activity assessment : Also known as the Eastern Cooperative Oncology Group (ECOG) scale, this assessment measures your ability to perform work and other daily activities. Electrocardiogram (ECG) : Sticky patches will be placed on your chest that will be connected by wires to a machine that will record the electrical activity of your heart. Laboratory tests : Blood and urine samples will be collected for safety tests and to check for certain cells, chemicals, and proteins. Medical history : A review of your current and past medical history, including bladder cancer history (ie, date of diagnosis and any past or current therapies and surgeries). Physical examination : Includes checking your general appearance, central and peripheral nervous system, head and neck (including ears, eyes, nose, mouth, and throat), respiratory system, cardiovascular system, gastrointestinal system, lymphatic system, urinary system, musculoskeletal system, and skin. Weight and height measurements will also be taken at the screening visit. Pregnancy tests : If you are a female able to become pregnant, a pregnancy test (urine or blood) will be performed before nadofaragene firadenovec administration. Quality of life questionnaires : Includes questions about your health-related quality of life. Study drug administration : Once every 3 months, a urinary catheter will be used to administer the study drug directly into the bladder. It will be kept in the bladder for 60 minutes. TURBT : transurethral resection of bladder tumor. A procedure when all visible tumor is removed through the urethra. The urethra is the tube that carries urine from the bladder to the outside of your body. Urine cytology : Cytology is the examination of cells from the body under a microscope. In a urine cytology exam, a doctor looks at cells collected from a urine specimen to see how they look and function. In this study the test checks for signs of cancer. Urinary symptom assessment : Includes questions about painful urination and urination timing and frequency. Vital signs : Includes checking your blood pressure, heart rate (pulse), and body temperature. Vital signs will be taken before and after study drug administration.

    What risks are involved for study participants?

    There are possible risks involved with any clinical study. The research staff will review the risks with you, and you will be closely monitored by the research staff throughout the clinical study.

    Why should I take part in this study?

    Participation in a clinical study is voluntary. Clinical studies are important for medical advances. By participating in the study, you will:

    • Be closely monitored through regular visits with your study doctor to check your condition

    • Be a part of discovering new health information that may help others in the future

    What are the costs to take part in this study?

    You will receive all study-related procedures and the study drug, nadofaragene firadenovec, free of charge. Certain participants may also be eligible for compensation for study-related travel expenses.

    Watch the video to learn more about ABLE-22 study

    Thank you for your interest in the ABLE-32 study. If you would like to see if you are eligible to participate, please find a site near you.

    Find a site near you

    Where can I learn more?

    If you're interested in learning more about the ABLE-32 study, including potential risks and benefits of participation, you can reach out to the study doctors listed below, or at Clinical Trials.gov