At a glance
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Avelumab as Single Agent in Metastatic or Locally Advanced Urothelial Cancer in Patients Unfit for Cisplatin
In Brief
A Phase 2 clinical trial evaluating Avelumab for Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer. Completed, enrolled 67 participants across 21 sites.
Detailed Summary
This is a single arm, open label, phase II study to evaluate the activity of avelumab (MSB0010718C) in patients with metastatic or locally advanced urothelial cancer considered unfit to cisplatin-based chemotherapy, to be conducted in conformance with Good Clinical Practices. Cisplatin-unfit patients will be defined if at least one of these characteristics is present: 1. ECOG-Performance status = 2; 2. Creatinine Clearance \< 60 ml/min; 3. Grade 2 or worse peripheral neuropathy or hearing loss; 4. Previous treatment with cisplatin for adjuvant intent in six months before the progression of disease.
Study Details
Timeline
Interventions
Patients will receive avelumab at standard dosage of 10 mg/kg as a 1-hour intravenous infusion once every 2 weeks (Q2W).