Clinical Trial

Atezolizumab + Guadecitabine in Patients With Checkpoint Inhibitor Refractory or Resistant Urothelial Carcinoma

Active, Not Recruiting Phase 2
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Summary
This is a single arm Phase II study with a safety run-in to identify the recommended phase II dose of the combination therapy of atezolizumab and guadecitabine. Patients with recurrent/advanced urothelial carcinoma (stage IV) who had previously progressed on check-point inhibitor therapy with PD-1 or PD-L1 targeting agents are eligible for this study. After a dose that is safe and tolerable has been established, a dose expansion phase (Phase II) will begin. This study will enroll a total of 4 to 53 patients depending upon the number of patients treated in the safety run-in phase and the number of subjects replaced during the phase II portion.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2017-06-06; most recent amendment 2022-08-15.
Status change: Active, Not Recruiting → Completed 2022-05-11
Status change: Suspended → Active, Not Recruiting 2020-08-17
Status change: Recruiting → Suspended 2020-05-06
Status change: Not Yet Recruiting → Recruiting 2017-11-29
Trial Details
NCT Number NCT03179943
Lead Sponsor Fox Chase Cancer Center
Collaborators: Stand Up To Cancer, Van Andel Research Institute
Conditions Urothelial Carcinoma
Enrollment 21 participants
Start Date 2017-11-27
Primary Completion 2020-07-12 (estimated)
Study Completion 2022-07 (estimated)
Updated on ClinicalTrials.gov 2021-11-04