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Title:
S1605 Phase II Trial of Atezolizumab in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Protocol Number:
NCTNS1605
Phase:
Phase II
Physician:
Trinity Bivalacqua
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
The purpose of this study is to test the good and bad effects of the investigational drug atezolizumab in stopping non-muscle invasive bladder cancer from coming back and progressing to muscle invasive bladder cancer.
Eligibility:
Patients with superficial bladder cancer that has not invaded into the bladder muscle wall and that did not respond to Bacillus Calmette-Guerin (BCG) may be eligible.
Treatment:
All study participants will get the same study treatment. You will receive atezolizumab into a vein once every 21 days for up to 17 times. If your cancer stops responding, you will stop taking the study drug. About 13 weeks after you start the study, you will have a test (cystoscopy) that allows the doctor to look at the lining of your bladder to see whether the cancer is responding to the treatment. After that you will have the cystoscopy again about every 3 months. Tissue samples of the lining of your bladder may also be taken during cystoscopy if it is suspected that the cancer has returned. If you have carcinoma in situ (CIS), you will automatically have a biopsy about 25 weeks after you start the study.You will get the study drug once every 21 days for up to 17 times. If there are no treatment delays, you will take the study drug for about 1 year, or as long as your disease does not get worse and the side effects are not too severe. After you finish the study drug, your doctor will continue to watch you for side effects and follow your condition for up to five years.
Population:
Adult
Last Update
03/05/2019 05:03 AM