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Efficacy of atezolizumab concurrent with radiotherapy in muscle-invasive bladder cancer
2018-004348-47Phase 2
Key facts
- Status
- Active
- Start
- May 2019
- Countries
- 1
- Sponsor
- SOGUG
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
- Drugs
- atezolizumab
- Conditions
- muscle-invasive bladder carcinoma (MIBC)
01
Overview
Phase 2, open-label, single-arm trial of atezolizumab in muscle-invasive bladder carcinoma (MIBC), sponsored by SOGUG. Primary endpoint: Pathological complete response. Started May 2019; status: active.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Atezolizumab concurrent with bladder radiotherapy
Single treatment arm where participants receive atezolizumab alongside definitive radiotherapy to the bladder.
03
Who it enrols
Adults (≥18 years) with muscle-invasive bladder cancer (likely urothelial carcinoma) eligible for bladder radiotherapy, without prior bladder radiotherapy, systemic chemotherapy or immune checkpoint inhibitor therapy; prior intravesical BCG for non-muscle-invasive disease is allowed.
04
Endpoints
Primary
Pathological complete response
Secondary
Overall survival
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