What is the purpose of the LEGEND study?
The LEGEND study will test if a study drug can safely help the body destroy cancer cells to ultimately delay, or ideally, prevent bladder removal for people with non-muscle invasive bladder cancer (NMIBC) that have not responded to bacillus Calmette-Guérin (BCG) therapy.
What will happen during the LEGEND study?
If you qualify and decide to join the LEGEND study, your active participation may last up to 48 weeks, and you may have up to 2 years of follow-up. The study is divided into the following periods:
Screening (about 2 weeks)
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You will have routine study tests and procedures to find out if you are eligible to participate in the study.
Study Drug (up to 48 weeks)
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You will receive at least 1 cycle, and as many as 4 cycles, of the study drug. One cycle is 12 weeks.
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You will receive the study drug once a week for the first 2 weeks of each cycle.
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You will have regular study visits for tests and procedures during each cycle. Some of these visits may take place at home.
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You will have a routine cystoscopy near the end of each cycle to assess whether or not you have responded to the study drug and determine the optimal path forward which may include continuing treatment with an additional dosing cycle.
Follow-up (up to 2 years)
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If the cancer has not come back after you complete 4 cycles, you will receive a phone call every month and have a follow-up study visit every 3 months for up to 2 years.
Who can join the LEGEND study?
You may be able to join the LEGEND study if you meet the following study requirements:
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18 years of age or older
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Diagnosed with NMIBC (bladder cancer that has not extended into the bladder muscle) that is unresponsive to, or returned after, BCG therapy
If you meet the requirements listed above, you may qualify to participate in the study.
Other study requirements will apply, please contact a study location for additional information.