Bladder Cancer
Bladder Cancer2
Bladder Cancer3
Bladder Cancer4

Websites for potential clinical study participants with bladder cancer

STUDY OVERVIEW

Some people with high-grade non-muscle invasive bladder cancer (NMIBC) may not respond to available therapies such as Bacillus Calmette-Guerin (BCG) immunotherapy, a treatment that helps the immune system fight cancer. This study is evaluating a study drug called nadofaragene firadenovec alone and in combination with chemotherapy or immunotherapy. 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 BCG treatment. Clinical studies like this one aim to find new and better ways of preventing and treating 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 when administered alone and in combination with chemotherapy or immunotherapy in adults with high-grade NMIBC.

  • How well tolerated the study drug is when administered alone and in combination with chemotherapy or immunotherapy in adults with high-grade NMIBC.

WHO CAN JOIN?

To be eligible for this study, you must:

  • Be at least 18 years of age

  • Be diagnosed with high-grade NMIBC

  • Have received and not responded to at least 2 courses of BCG immunotherapy for NMIBC

Get Started

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

WHAT WILL HAPPEN IF I TAKE PART?

1

If you are eligible to participate, you will:

  • Be randomly assigned to one of the three following groups (arms) during the study: • Arm 1: will receive nadofaragene firadenovec • Arm 2: will receive nadofaragene firadenovec plus chemotherapy • Arm 3: will receive nadofaragene firadenovec plus immunotherapy
  • You, the study doctor, and study staff will be aware of your study group assignment.
  • Nadofaragene firadenovec, chemotherapy, and immunotherapy will be administered at the study visits. Nadofaragene firadenovec and chemotherapy are both given directly into the bladder through a urinary catheter. Immunotherapy is given through an intravenous (IV; into a vein) infusion.
  • Laboratory tests, cystoscopy (procedure to examine the bladder and urethra), heart tests, bladder biopsies, and other assessments and questionnaires (see the Frequently Asked Questions section) will be conducted as part of this study.
  • The ABLE-22 study consists of three parts: a screening period (up to 2 months), a treatment period (up to 2 years), and a follow-up period (up to 3 years). The total study length is 3 years.

    • 2

    Screening Period (up to 2 months)

  • Written informed consent must be obtained prior to any trial-related 
procedures.
  • Eligible participants have undergone a cystoscopy and 
transurethral resection of bladder tumor (TURBT) with complete 
resection 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 subjects will be randomized to one of three treatment arms. • Arm 1: Nadofaragene firadenovec • Arm 2: Nadofaragene firadenovec + chemotherapy (gemcitabine and     docetaxel) • Arm 3: Nadofaragene firadenovec + immunotherapy (pembrolizumab)

    • 3

    Treatment Period (up to 2 years)

  • All participants will receive nadofaragene firadenovec once quarterly the first 12 months, whereafter this treatment is optional up to month 24.
  • For participants in Arm 2, you will also receive chemotherapy weekly for the first 6 weeks, and thereafter monthly.
  • For participants in Arm 3, you will also receive immunotherapy once 
every 6 weeks.
  • Apart from the visits when study treatment will be given, there will also be quarterly visits at which the status of the bladder cancer will be checked.
  • The study staff will contact you by phone each month that they 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.
  • If the cancer returns or is progressing the study treatment will be stopped. Other treatment will be at the discretion of the treating physician. A follow-up period will be entered.

    • 4

    Follow-up Period (up to 3 years)

  • During this period, the study staff will collect information to assess participants’ bladder cancer and overall health and well-being. You will attend quarterly visits up to 2 years. Patients will be contacted twice a year by phone.

    • 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?

    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.

    What is ADSTILADRIN® (one of the study drugs)?

    The study drug, 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-22 study important?

    Some people with high-grade NMIBC may not respond to available therapies such as BCG immunotherapy, a treatment that helps the immune system fight cancer. This study is evaluating the study drug, nadofaragene firadenovec, to find out how effective and tolerable it is when administered alone and in combination with chemotherapy or immunotherapy in adults with high-grade NMIBC. 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 nadofaragene firadenovec is alone and in combination with chemotherapy and immunotherapy.

    Who can participate in the ABLE-22 study?

    To be eligible for this study, you must: • Be at least 18 years of age • Be diagnosed with high-grade NMIBC • Have received and not responded to at least 2 courses of BCG immunotherapy for NMIBC This is not a complete list of study requirements. The study doctor will review the full requirements with you.

    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) 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 lens is 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 certain visits. Pregnancy tests : If you are a female able to become pregnant, a pregnancy test (urine or blood) will be performed before study drug administration. Quality of life questionnaires : Includes questions about your health-related quality of life. Study drug administration: • Nadofaragene firadenovec: 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. • Chemotherapy (gemcitabine and docetaxel): Weekly for the first 6 weeks, and thereafter monthly, a urinary catheter will be used to administer the study drug directly into the bladder. • Immunotherapy (pembrolizumab): Once every 6 weeks, given through an intravenous (IV; into a vein) infusion. 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 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 : Questionnaire 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.

    How long will this study last?

    Participants will be in the study for up to 36 months, which includes a study treatment period (up to Month 24) and a follow-up period (up to Month 36).

    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?

    Participants will receive all study-related procedures and the study drugs 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-22 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-22 study, including potential risks and benefits of participation, you can reach out to the study doctors listed below, or at Clinical Trials.gov