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A Randomized Trial of Immunotherapy with or without Surgical Treatment
In response to the COVID pandemic, Scripps Health has temporarily suspended enrollment for all clinical trials. Exceptions will exist for trials with curative intent, life-saving treatment or when no standard of care exists. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.
Munveer S Bhangoo, MD
This study will assess the safety and effectiveness of Pembrolizumab (KEYTRUDA) compared to surgical treatment (removal of bladder) alone in patients with Muscle – invasive Bladder Cancer that are ineligible for a standard treatment regimen with cisplatin.
Be male or female, 18 years of age or older
Have a confirmed diagnosis of Muscle – invasive Bladder Cancer, Clinical Stage T2-T4aN0M0
Be deemed ineligible to receive cisplatin chemotherapy
Be eligible for surgical treatment per his/her urologist and/or oncologist, and agree to planned surgical treatment
Have received prior systemic anti-cancer or immune therapy
Be pregnant or breastfeeding or expecting to conceive or father children within the defined study duration
Have a known history of HIV, hepatitis B or active hepatitis C
Patients enrolled in this trial will be randomly selected to receive treatment with Pembrolizumab, before and after surgery with cystectomy (surgical removal of the bladder), OR to cystectomy alone (no Pembrolizumab medication).
All treatments and physician visits will take place at Scripps Clinic Torrey Pines. Study treatment will occur for approximately 1 year and patients will be followed continuously after treatment.
For more information search for NCT03924895 at www.clinicaltrials.gov