Avelumab Program Rollover Study

• Research type

  Research Study

• Full title

  An Open-Label, Multicenter Follow-up Study to Collect Long-term Data on Participants from Multiple Avelumab (MSB0010718C) Clinical Studies

• IRAS ID

  261546

• Contact name

  Elisa Fomtana

• Contact email

  elisa.fontana@hcahealthcare.co.uk

• Sponsor organisation

  Merck KGaA

• Eudract number

  2018-003711-21

• Clinicaltrials.gov Identifier

  NCT03815643

• Duration of Study in the UK

  5 years, 5 months, 12 days

• Research summary

  There are a number of ongoing avelumab clinical studies in solid tumor indications with protocol numbers: EMR 100070-001; EMR 100070-008; EMR100070-002; EMR100070-004.
  These studies are going to closed.

  The studies EMR 100070-001 and EMR100070-004 are currently ongoing in the UK and were reviewed and approved.
  Participants from these studies are still on active treatment with avelumab or in followup for survival status.
  This study is designed to provide continuous access to treatment with avelumab for eligible participants from ongoing avelumab parent studies and to collect long-term safety and efficacy data. Specifically, the following participants will be eligible for enrollment in this rollover study:
  • Participants who are currently on active avelumab treatment in any parent study, regardless of indication.
  • Participants with non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), urothelial carcinoma (UC), or ovarian cancer indications who are in long-term follow-up (LTFU).
  • Participants who experienced confirmed complete response (CR) in the parent study and discontinued avelumab treatment according to the parent study protocol.
  If participants with CR experience a relapse of their disease while in follow-up during the roll-over study, treatment with avelumab may be resumed if considered appropriate by the Investigator

  In the UK:
  - There are only Patients in the LTFU Phase and one Patient who experience Complete Response.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  19/SC/0189

• Date of REC Opinion

  19 Jun 2019

• REC opinion

  Further Information Favourable Opinion