Atezolizumab in Treating Patients With Recurrent BCG-Unresponsive Non-muscle Invasive Bladder Cancer

Conditions

• Recurrent Bladder Urothelial Carcinoma
• Stage 0a Bladder Urothelial Carcinoma AJCC v6 and v7
• Stage 0is Bladder Urothelial Carcinoma AJCC v6 and v7
• Stage I Bladder Urothelial Carcinoma AJCC v6 and v7

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Atezolizumab — DRUG
  Given IV

Study Details

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.

Key Dates

Start date

Mar 13, 2017

Status verified

May 2025

Primary completion

Jun 1, 2023

Completion

Jun 26, 2024

Study Design

Enrollment

172 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Complete Response (CR) Rate in the Subset of Patients With Carcinoma in Situ (CIS) [ Time Frame: At 25 weeks ]

Locations (269)

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