Phase 2 Trial of Atezolizumab in Bacillus Calmette-Guerin-unresponsive High-risk Non-muscle-invasive Bladder Cancer: SWOG S1605.

ABSTRACT:

Background

Although radical cystectomy (RC) is the standard of care for patients with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC), many patients are ineligible for surgery or elect bladder preservation.

Objective

To evaluate the efficacy and safety of atezolizumab in BCG-unresponsive high-risk NMIBC.

Design, setting, and participants

This was a single-arm phase 2 trial in patients with BCG-unresponsive high-risk NMIBC who were ineligible for or declined RC.

Intervention

Intravenous atezolizumab every 3 wk for 1 yr.

Outcome measurements and statistical analysis

The primary endpoint was the pathological complete response (CR) rate for patients with carcinoma in situ (CIS) determined via mandatory biopsy

SUBMITTER: Black PC 

PROVIDER: S-EPMC10869634 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature