Learn about the ADVANCED-3 clinical study
If you have a specific type of bladder cancer called high-grade (HG) non-muscle invasive bladder cancer (NMIBC), you may be able to join this study.
What is a clinical study?
A clinical study (also called a clinical trial) is research done with people to learn more about a possible treatment, called a study drug. Clinical studies help researchers understand whether a study drug is safe to use and how well it may work for certain conditions.
What is TARA-002?
TARA-002 is a study drug designed to activate immune system cells that fight cancer. It is given as a liquid directly into the bladder.
TARA-002 is similar to a drug called OK-432 that is approved for doctors to use to treat other types of cancer in Japan and Taiwan, including stomach and lung cancer.
TARA-002 is not approved for the treatment of HG NMIBC.
Can I join this study?
You may be able to join this study if you have HG NMIBC and you:
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Are 18 years old or older
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Have HG NMIBC with carcinoma in situ (CIS), which is a flat patch of cancer on the inside wall of your bladder that hasn’t grown into your bladder’s muscle tissue
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Cannot or will not get Bacille Calmette-Guérin (BCG) to treat your HG NMIBC
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Are not allergic to penicillin (which TARA-002 contains) or similar antibiotics
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Do not have certain other health conditions
There are other criteria that you must meet. The study staff will do tests to make sure you can be in the study.
Will I get TARA-002 in the study?
Study staff will assign you by equal chance to receive one of these study treatments:
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TARA-002
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Chemotherapy, which will be the study doctor’s choice of either gemcitabine or mitomycin C
Both study treatments are given as intravesical therapy, which is explained below.
Intravesical therapy is given through a thin, flexible tube (urinary catheter) inserted through the urethra (which carries urine out of your body) and into the bladder.
Each treatment will stay in your bladder for about 2 hours. Then you will urinate it out.
You will get your assigned treatment for up to 2 years. Your first 6 doses will be given once a week. Then, how often you receive treatment will depend on which study treatment you are assigned.
If you are assigned chemotherapy and it does not treat your cancer after at least 3 months, you may be able to get TARA-002 instead.
What will happen during this study?
You will be in the study for up to 5 years and have up to 45 visits to the study site. You may have more visits, if needed, for study staff to check your health.
During the study, study staff will:
Talk with you about the study. If you choose to join, you will then sign an informed consent form.
Ask questions and do some tests to be sure you can be in this study. This is called screening.
Assign you by equal chance to receive either TARA-002 or chemotherapy for up to 2 years.
Ask you to have tests, including:
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Physical exams
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Blood and urine tests
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Imaging tests, such as MRI, CT, or cystoscopy (imaging inside your urethra and bladder)
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A heart test called an ECG
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Biopsies, in which the study doctor will take small tissue samples from your bladder
Check your bladder and overall health after your last dose of treatment at study visits about every 6 months for about 3 years
Will I have any costs or be paid?
You will not have any costs to be in the study.
You may be paid back (reimbursed) for certain costs related to the study, such as time and travel costs for study visits.
How can I learn more about this study?
Visit clinicaltrials.gov to learn more about this study and see the study site locations.
Email clinicaltrials@protaratx.com to see if you can join.
It may also be helpful to speak with your doctor, and family or friends, to decide if this study is right for you.