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Neoadjuvant Atezolizumab in Advanced Urothelial Bladder Cancer by BASQ Type

NCT03577132Phase 2

Key facts

Status: Unknown
Start: Aug 2018
Primary completion: May 2020
Sponsor: Seoul National University Hospital
Modality: Monoclonal Antibodies

Drugs: atezolizumab
Conditions: urothelial carcinoma (UC)

Overview

Phase 2, open-label trial of atezolizumab in urothelial carcinoma (UC) (2 arms), sponsored by Seoul National University Hospital. Primary endpoint: Objective Pathological Response (pT0 change) at 4 weeks. Status: unknown.

Design

2 arms

Study design: Non-randomizedOpen-label

Luminal type
Patients with Luminal type tumors (KRT5/6-KRT14-FOXA1+GATA3+) receiving neoadjuvant atezolizumab.
Basal type
Patients with Basal type tumors (KRT5/6+KRT14+FOXA1-GATA3-) receiving neoadjuvant atezolizumab.

Endpoints

Primary

Objective Pathological Response (pT0 change)4 weeks

Secondary

Progression-Free Survival1 year

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