A phase 1b combination study of PDR001
Research type
Research Study
Full title
Phase Ib, open-label, multi-centre study to characterise the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589)
IRAS ID
209571
Contact name
Alexander Chesi
Contact email
Sponsor organisation
Novartis Pharma Services
Eudract number
2016-000654-35
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 15 days
Research summary
Research Summary
This is a multicentre, open label, phase Ib study which will enrol approximately 350 patients with advanced cancer. This study has two main parts, dose escalation and dose expansion. The first part (“escalation part”) will test different doses of LCL161 or panobinostat given together with a fixed dose PDR001 400 mg every 4 weeks and will establish a dose for the combination that will be explored in the “expansion part” of the study.
The purpose of this study is to identify the best dose of LCL161, everolimus (RAD001) or panobinostat (LBH589)to take with a fixed dose of PDR001 that can be given safely to patients and to evaluate how well the combination might work in treating patients with cancer.
Only one dose of everolimus will be tested, based on the prior experience with that dose in healthy elderly subjects.
The UK will be joining this study at the dose expansion part.
Summary of Results
The evaluated combinations of PDR001 with LBH589, LCL161 and RAD001, while being generally well tolerated, did not identify a combination treatment with efficacy clearly superior to that of single agent PDR001. This study also sought to explore whether ~6 months of treatment with PDR001 in combination would be sufficient to induce a durable clinical benefit. There were too few subjects with clinical response to assess this question, but two patients with NSCLC treated with PDR001 + LCL161 remained well until study completion after the initial six cycles of treatment, suggesting that for some subjects, six months of treatment might be sufficient to provide durable clinical benefit.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0640
Date of REC Opinion
4 Jan 2017
REC opinion
Further Information Favourable Opinion