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Duravelo-2 is a clinical study investigating a potential new cancer drug called BT8009 (also called “the investigational drug”). The study will examine whether BT8009 can work against unresectable or metastatic UC. Duravelo-2 will also compare the effectiveness of BT8009 to some approved cancer medications.
Study participants may be able to join the study if they meet the following requirements:
You must be at least 18 years old
Unresectable or metastatic UC
For further information about the requirements to participate in the Duravelo-2 study, please contact your study doctor or treating physician.
You can expect the following if you join:
At least half of participants (50%) will receive either BT8009 alone or in combination with an approved cancer drug called pembrolizumab. All other participants will receive standard cancer drug(s). BT8009, pembrolizumab, and the standard cancer drugs are all given via IV infusion.
Important notes about participating in Duravelo-2
Up to 956 participants will take part in the Duravelo-2 study.
There are potential risks and benefits to participating in any clinical study. You should only enroll in a clinical research study after careful discussion with a study doctor.
You may experience side effects from the study drug(s) or risks that are not yet known. Side effects are unwanted and usually unpleasant reactions that may happen during a study.
In any clinical research study, there is a chance that your condition may improve, stay the same, or get worse.
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason without any resulting detriment and without having to provide a justification.
Urothelial carcinoma (sometimes referred to as transitional cell carcinoma), or “UC”, is a cancer of the urinary tract system. The urinary tract system includes the kidneys, bladder, and special tubes called ureters. The purpose of the urinary tract system is to help your body eliminate waste via urine (pee). First, urine forms in the kidneys. Then, it passes into the bladder via ureters. Finally, it exits the bladder (and then the body) via a specialized ureter called the urethra.
The insides of the kidneys, bladder, and ureters are all coated with a protective lining called the urothelium, which helps contain the urine. Over time, various factors can damage the urothelium. Urothelial carcinoma occurs when a damaged urothelium begins to grow cancerous cells, which then form tumors. Often, UC tumors spread beyond their original location. When this happens, the cancer is called metastatic. If it cannot be removed through surgery, it is called unresectable. This study is for people whose UC is metastatic, unresectable, or both.
Scientists and researchers are working hard to find new options for people with metastatic and/or unresectable UC. You may or may not benefit from your participation in this study. Even if you do not benefit from participating in this study, information from this study could help advance UC research, which may help others with UC in the future.
UC can occur in other parts of the urinary tract system without entering the bladder. Such cases of UC are not bladder cancer. Bladder cancer only occurs in cells within the bladder. Most cases of bladder cancer (about 90%) begin in the urothelium. Bladder cancers that begin in the urothelium are also UC.
You will know that you have advanced UC if you have received this diagnosis. If your UC is unresectable (cannot be removed through surgery) or metastatic (has spread beyond its original location), you may have advanced UC.
Here are some common questions and answers about study participation.
Clinical studies, or trials, help explore whether an investigational medical strategy, device, or drug can be used safety and effectively for people. Before any drug can be approved and made available to the public, it must go through several phases of clinical research and be approved by the competent regulatory authorities.
Before enrolling in a clinical trial, you must sign a Patient Information Sheet and Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, potential benefits and risks, your rights, and the tests and procedures you will receive. For further information about eligibility requirements to participate in the Duravelo-2 study, please contact your study doctor/treating physician.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational drug or standard treatment and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical studies is your choice, and you may stop at any time, without any resulting detriment and without having to provide a justification.
If you have additional questions about participating in a clinical study, please contact your [doctor/treating physician]
Thank you for considering taking part in the Duravelo-2 clinical study sponsored by BicycleTx Limited.