Information sheet on the clinical trial - AVENUE

Main indication

Advanced and/or metastatic urothelial carcinoma

Study name (study type)

AVENUE (non-interventional study)

Study sponsor

Merck

Registration number

No EudraCT/NCT registration

FOR SKIMMERS:

Study for patients with advanced and/or metastatic urothelial carcinoma. Treatment data and questionnaires will be collected from the patients. The study is an observational study and has no influence on the treatment method prescribed by the physician.

DETAILED INFORMATION:

This international, multicenter, prospective, single-arm observational study, conducted under real-world conditions, focuses on people with locally advanced or metastatic urothelial carcinoma. The objective is to investigate the efficacy and safety of treatment with avelumab as maintenance therapy following completion of platinum-based chemotherapy as first-line treatment. Treatment will be administered under routine conditions of daily clinical practice in various countries and in accordance with the guidelines set forth in the SmPC for avelumab. 

Study Title

Avelumab for the Treatment of Urothelial Carcinoma in Clinical Practice – the Non-Interventional Study (NIS) AVENUE

Which conditions are being treated in the study?

Advanced and/or metastatic urothelial carcinoma

Are specific subgroups of patients with one of the mentioned conditions being treated?

No

Background on the study medication

Avelumab is a fully human monoclonal antibody belonging to the class of immune checkpoint inhibitors. It is being developed for use in cancer immunotherapy.

Study Protocol

Documentation of treatment with avelumab extends over 36 months, regardless of whether patients discontinue avelumab maintenance therapy or not. The frequency of visits and the type of examinations and assessments performed are based on routine clinical practice. 

Inclusion Criteria

• Patients who are 18 years of age or older
• Patients with locally advanced and/or metastatic disease, regardless of histological findings
• Patients who have completed platinum-based chemotherapy as first-line therapy and in whom no signs of disease progression have been observed
• Patients who have not yet received avelumab as part of first-line maintenance therapy or who have already been treated with one cycle of avelumab (according to the SmPC)

Exclusion criteria

• Patients with contraindications to avelumab 
• Patients who, within 28 days prior to the start of maintenance therapy with avelumab, participated in a clinical intervention study investigating the effect of a study drug

Your contacts: Investigators at the center and contact information

Dr. Guido Platz

Email: platz@gp-ruesselsheim.de

Phone: 06142 88-1361

Responsible staff members in the outpatient study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032