A Randomized Trial of Immunotherapy with or without Surgical Treatment

COVID-19 update:

In response to the COVID pandemic, Scripps Health has either temporarily suspended or limited enrollment with appropriate precautions for all clinical trials. For questions, please call Scripps Office for the Protection of Research Subjects at 858-678-6402.

Trial ID:: IRB-19-7392; 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.

Inclusion Criteria

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

Exclusion Criteria

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

Additional Info

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

Contact Info:

Gail Moore
Moore.Gail@scrippshealth.org
858-554-8365