Avelumab as Single Agent in Metastatic or Locally Advanced Urothelial Cancer in Patients Unfit for Cisplatin. The ARIES Study

• Status: Unknown status
• Trial end date: 2021-01-01

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.

• Phase: Phase 2

Details

• Lead Sponsor: Consorzio Oncotech
• Treatments: Antibodies, Monoclonal; Avelumab; Cisplatin