Avelumab for locally advanced or metastatic urothelial carcinoma

• Research type

  Research Study

• Full title

  A MULTI-CENTRE NON-INTERVENTIONAL STUDY TO DESCRIBE THE EARLY CLINICAL EXPERIENCE OF AVELUMAB USED AS MONOTHERAPY FOR FIRST- LINE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE PROGRESSION-FREE FOLLOWING PLATINUM-BASED CHEMOTHERAPY

• IRAS ID

  301370

• Contact name

  Robert Jones

• Contact email

  r.jones@beatson.gla.ac.uk

• Sponsor organisation

  Pfizer Limited

• Duration of Study in the UK

  2 years, 2 months, 28 days

• Research summary

  The purpose of this non-interventional study is to describe the early clinical real-world outcomes of patients treated with avelumab as monotherapy for the 1L maintenance treatment of locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy. As of September 2020, patients in the UK meeting the UC indication have been provided access to avelumab via an Early Access to Medicines Scheme (EAMS) and subsequently via a company supported Managed Access Programme. This study aims to investigate patients who received avelumab in secondary/tertiary care in the UK through either the EAMS, EAMS extension or through NHS commissioning. The primary objective of this study is to estimate real-world overall survival in this real-world cohort.

  Outcomes and characteristics relating to overall survival will be extracted from records of adult patients. The collected data are entered as part of routine care
  into electronic patient records and paper-based charts. Approximately 100 patients will be recruited across 10-12 geographically-spread selected centres and followed-up for up to 24 months after avelumab initiation. These patients will be above 18 years and have a confirmed diagnosis of locally advanced or metastatic stage IV UC, they would have received a platinum-based chemotherapy which they had response to or achieved a stable disease state and they should also have received maintenance avelumab.

• REC name

  Wales REC 6

• REC reference

  21/WA/0343

• Date of REC Opinion

  5 Oct 2021

• REC opinion

  Favourable Opinion