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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Fox Chase Cancer Center
Study ID
NCT03179943
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 27, 2017
Status verified
Nov 2021
Primary completion
Jul 12, 2020
Completion
Jul 31, 2022

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Atezolizumab + Guadecitabine

Primary Outcome Measure

Maximum tolerated dose of Guadecitabine in combination of Atezolizumab in safety run-in phase [ Time Frame: 2-3 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
USC Norris Hospital and ClinicsLos AngelesCalifornia90033-
Johns Hopkins University School of MedicineBaltimoreMaryland21287-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Los Angeles, CA

By condition
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By specialty
OncologyUrology
By research site
USC Norris Hospital and Clinics· Los Angeles, CAJohns Hopkins University School of Medicine· Baltimore, MDFox Chase Cancer Center· Philadelphia, PA

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