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

NCT03891238 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-02-01

No results posted yet for this study

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.

Conditions

  • Metastatic or Locally Advanced PD-L1 Positive Urothelial Cancer

Interventions

DRUG

Avelumab

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

Sponsors & Collaborators

  • Consorzio Oncotech

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2021-09-15
Completion
2021-09-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03891238 on ClinicalTrials.gov