Trial intelligence / Profile preview

Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

NCT03775265Phase 3

Key facts

Status
Active, not recruiting
Start
Jun 2019
Primary completion
Jun 2027
Countries
1
Sponsor
National Cancer Institute
Modality
Monoclonal Antibodies
Conditions
muscle-invasive bladder cancer (MIBC)
01

Overview

Phase 3, randomised, open-label trial of atezolizumab in muscle-invasive bladder cancer (MIBC) (2 arms), sponsored by National Cancer Institute. Primary endpoint: Bladder intact event-free survival at 5 years. Started Jun 2019; status: active, not recruiting.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Arm I (RT, chemotherapy)

    Standard of care chemoradiotherapy

  • Arm II (RT, chemotherapy, atezolizumab)

    Chemoradiotherapy + Atezolizumab

03

Who it enrols

Adults with T2-T4a N0M0 muscle invasive bladder cancer who have not received prior systemic chemotherapy or pelvic radiation, with adequate organ function and Zubrod PS <= 2.

04

Endpoints

Primary

  • Bladder intact event-free survival

Secondary

  • Overall survival

  • Modified bladder intact event-free survival

  • Biopsy response

  • Complete response duration

  • Progression-free survival

  • Metastasis-free survival

  • Cancer-specific survival

  • Quality of life

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