Overview

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

Status:
Active, not recruiting

Trial end date:
2022-07-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Fox Chase Cancer Center

Collaborators:

Stand Up To Cancer
Van Andel Research Institute

Treatments:

Antibodies, Monoclonal
Atezolizumab
Guadecitabine