PDR001 in Advanced or Metastatic Non-Functional NeuroendocrineTumours
Research type
Research Study
Full title
An open label phase II study to evaluate the efficacy and safety of PDR001 in patients with advanced or metastatic non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin who have progressed on prior treatment.
IRAS ID
212451
Contact name
Daniel Krell
Contact email
Sponsor organisation
Novartis Pharma AG
Eudract number
2016-002522-36
Duration of Study in the UK
2 years, 8 months, 17 days
Research summary
Cancer cells from a wide range of tumour types exploit immune checkpoint pathways, such as PD-1/PD-L1, to avoid their detection and elimination by immune system. PDR001 is a novel high-affinity antibody directed against PD-1 receptor. By blocking PD-1, PDR001 may promote a robust anti-tumour immune response and reduce tumour growth.
The purpose of this study is to find out if the study drug PDR001 is safe and has beneficial effects in patients who have neuroendocrine tumours (NETs) of the pancreas, of the gastrointestinal region, or of the thorax (lung and thymus). Neuroendocrine tumours are so-called because they produce hormones. This study is only concerned about non-functional neuroendocrine tumours that are not associated with symptoms from substances they produce and neuroendocrine tumours that have spread to other parts of the body or have progressed on previous treatment.
Patients will receive PDR001 at a flat dose of 400 mg every 4 weeks, given intravenously as a 30 minute infusion, for up to two years. Based on the safety profile observed in the previous phase I study and the expected effects, 400 mg every 4 weeks is expected to be a safe and efficacious dose.
Patients will be carefully monitored for safety and efficacy during the study and will be asked to visit the study hospital every 4 weeks.
Approximately 90 patients will be invited to take part in this study from 18 different countries, including UK.
This trial is sponsored by the pharmaceutical company named Novartis.REC name
London - Surrey Borders Research Ethics Committee
REC reference
17/LO/0262
Date of REC Opinion
29 Mar 2017
REC opinion
Further Information Favourable Opinion