AZ D419EC00001 Phase I/II, Durvalumab and Tremelimumab in Children
Research type
Research Study
Full title
Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability,and Preliminary Efficacy of Durvalumab Monotherapy or Durvalumab in Combination with Tremelimumab in Pediatric Patients with Advanced Solid Tumors and Hematological Malignancies
IRAS ID
258022
Contact name
Darren Hargrave
Contact email
Sponsor organisation
Astra Zeneca AB
Eudract number
2018-003118-42
Duration of Study in the UK
4 years, 11 months, 21 days
Research summary
This is an international study that will be carried out on children from birth to <eighteen years of age at the time of screening with advanced cancer to find out more about the potential use of durvalumab and tremelimumab. Specifically, the study will look at how safe these investigational medications are in children and whether children can tolerate the doses that have been tolerated in adult studies. It will also try to find initial information on whether the investigational medications provide benefit to children with advanced cancer.\n\nThe two investigational medications will be given to children as an infusion into a vein (or a port). The doctors and nurses carrying out the study (the study team) will then carry out a number of tests and examinations on participants to assess response to the investigational medications, and the effect on their bodies. Durvalumab when given by itself has been approved by the United States Food and Drug Administration (FDA) for the treatment of a certain type of bladder cancer and lung cancer in adults. It is also approved in the European Union for lung cancer in adults. Treatment of cancer with the combination of durvalumab and tremelimumab is already being tested in adults and in this study will be tested in children for the first time.\n\nThe research study will be carried out in NHS hospitals across the United Kingdom and also globally and is planned to go on for about six years and may include up to about 230 children with advanced forms of certain cancers. The study will be carried out in about seven countries at about nineteen different study centres.\n
REC name
South West - Central Bristol Research Ethics Committee
REC reference
19/SW/0036
Date of REC Opinion
16 Apr 2019
REC opinion
Further Information Favourable Opinion