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Avelumab and Radiation in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
NCT03747419Phase 2
Key facts
- Status
- Terminated
- Start
- Dec 2018
- Primary completion
- Feb 2025
- Countries
- 1
- Sponsor
- Dana-Farber Cancer Institute
- Modality
- Immune Checkpoint Inhibitors, Recombinant Proteins and Enzymes
- Drugs
- avelumab
- Conditions
- muscle-invasive bladder cancer (MIBC)
01
Overview
Phase 2, open-label, single-arm trial of avelumab in muscle-invasive bladder cancer (MIBC), sponsored by Dana-Farber Cancer Institute. Primary endpoint: Complete Clinical Response Rate at 3 months. Started Dec 2018; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Avelumab and Bladder-Directed Radiation
Avelumab IV q2w + Radiation
03
Who it enrols
Patients with histologically confirmed muscle-invasive urothelial carcinoma (T2-T4a) who are ineligible for cisplatin-based chemotherapy due to renal impairment, hearing loss, neuropathy, or heart failure.
04
Endpoints
Primary
Complete Clinical Response Rate
Secondary
Overall Survival
Progression Free Survival
Metastases-free Survival
Locoregional Recurrence Rate
Change in Quality of Life Outcomes
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