NCT03891238

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

Avelumab as Single Agent in Metastatic or Locally Advanced Urothelial Cancer in Patients Unfit for Cisplatin

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Consorzio Oncotech · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Each subject will participate in the trial from the time the subject signs the Informed Consent Form (ICF) through the final contact. After a screening phase of 28 days, each subject will receive the treatment. Treatment on trial will continue until disease progression is confirmed by the investigator/site radiologist, unacceptable adverse event(s), intercurrent illness that prevents further administration of treatment, investigator's decision to withdraw the subject, subject withdrawals consent, pregnancy of the subject, noncompliance with trial treatment or procedures requirements, or administrative reasons. The study treatment may be continued after radiological progression of disease at physician discretion and if improvement of symptoms or not new symptoms were reported by the patient despite the radiological progression of disease. Subjects who attain a complete response may consider stopping trial treatment if they meet criteria for holding therapy. After the end of treatment given the potential risk for delayed immune-related toxicities, safety follow-up must be performed up to 90 days after the last dose of avelumab administration. The extended safety follow-up beyond 30 days after last study drug administration may be performed either via a site visit or via a telephone call with subsequent site visit requested in case any concerns noted during the telephone call. Subjects who discontinue for reasons other than disease progression will have post-treatment follow-up every 12 weeks for disease status until disease progression is confirmed by the investigator/site radiologist, initiating a non-study cancer treatment, withdrawing consent, or becoming lost to follow-up. All subjects will be followed by telephone for overall survival every 12 weeks until death, withdrawal of consent, or the end of the trial.

Conditions

• Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Avelumab	Patients will receive avelumab at standard dosage of 10 mg/kg as a 1-hour intravenous infusion once every 2 weeks (Q2W).

Timeline

• Start date: 2019-02-06
• Primary completion: 2021-09-15
• Completion: 2021-09-15
• First posted: 2019-03-26
• Last updated: 2024-02-01

Locations

21 sites across 1 country: Italy