Purpose

This phase II trial studies how well atezolizumab works in treating patients with non-muscle invasive bladder cancer that has come back (recurrent) and has not responded to treatment (refractory) with Bacillus Calmette-Guerin (BCG). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Category

IRB Number
20180230HU
NCT Number
NCT02844816
Open to Enrollment
Yes
Sponsor
National Cancer Institute (NCI) -



Study Contact

Principal Investigator
Chethan Ramamurthy

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Chethan Ramamurthy
(210) 450-1667
ramamurthyc@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

    Exclusion Criteria


      Study Design

      Phase
      Phase 2
      Study Type
      Interventional
      Allocation
      N/A
      Intervention Model
      Single Group Assignment
      Primary Purpose
      Treatment
      Masking
      None (Open Label)
      Condition
    1. Recurrent Bladder Urothelial Carcinoma
    2. Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7
    3. Stage 0is Bladder Urothelial Carcinoma AJCC v6 and v7
    4. Stage I Bladder Urothelial Carcinoma AJCC v6 and v7
    5. Arm Groups

      ArmDescriptionIntervention
      Experimental

      Treatment (atezolizumab)

      Patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 17 cycles (51 weeks) in the absence of disease progression or unacceptable toxicity.
    6. Drug: Atezolizumab

      Given IV

      Other names:

      • MPDL 3280A
      • MPDL 328OA
      • MPDL-3280A
      • MPDL3280A
      • MPDL328OA
      • RG7446
      • RO5541267
      • Tecentriq