NCT03179943

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

GU-114: Overcoming Checkpoint Inhibitor Resistance With Epigenetic Therapy in Urothelial Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Fox Chase Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	Atezolizumab	Patients will be administered atezolizumab intravenously on day 1 and day 22 of a 6 week cycle for the period of 8 cycles.
DRUG	Guadecitabine	Guadecitabine will be administered subcutaneously on days 1 through 5 of the 6 week cycle for the period of 4 cycles

Timeline

• Start date: 2017-11-27
• Primary completion: 2020-07-12
• Completion: 2022-07-01
• First posted: 2017-06-07
• Last updated: 2021-11-04

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study