Evaluation of avelumab* combined with axitinib in advanced RCC
Research type
Research Study
Full title
A PHASE 1B, OPEN-LABEL, DOSE-FINDING STUDY TO EVALUATE SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF AVELUMAB (MSB0010718C) IN COMBINATION WITH AXITINIB (AG-013736) IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED RENAL CELL CANCER
IRAS ID
182571
Contact name
Holly Spencer
Contact email
Sponsor organisation
Pfizer Inc., 235 East 42nd Street, New York, NY 10017
Eudract number
2015-001137-25
Duration of Study in the UK
0 years, 10 months, 15 days
Research summary
Renal cell carcinoma (RCC) is the most common kidney cancer. There has been development and approval of other treatments that improved patient outcomes in advanced RCC (aRCC), however, lasting improved patient outcomes are minimal and patients are developing resistance to the standard of care drugs.
To address this, research has progressed to an approach to help immune system to fight against cancer cells. Upregulation of a specific receptor (called programmed death-1 (PD-1) receptor) on some cells of the immune-system that infiltrate into the tumours, and of its ligand PD-L1 on the tumour cells, are associated with more aggressive disease and poor prognosis. Blocking PD-1/PD-L1 interaction is a new approach for aRCC, which has shown single-agent efficacy in patients whose disease has progressed following prior therapy. Preliminary study results have demonstrated benefits of combining a PD-1 or PD-L1 antibody (drug able to attach specific cancer cells) with anti-vascular endothelial growth factor (VEGF) pathway agent (i.e..drug able to inhibit the production of blood vessels) in aRCC patients. Avelumab*is antibody that specifically blocks PD-L1, while axitinib is an anti-VEGF pathway agent.The addition of the PD-L1 inhibitor avelumab to the VEGF pathway inhibitor axitinib may provide additional benefit compared to treatment with an anti-VEGFR inhibitor alone without unacceptable toxicity in previously untreated aRCC patients.
There are two parts to this study –
1. Dose-Finding: different doses of avelumab in combination with axitinib will be studied to find the dose combination used in the dose expansion part.
2. Dose Expansion: is being done to learn about the safety and effects of the avelumab-axitinib drug combination, and to study the effect of avelumab and axitinib on each other.About 15 to 55 participants will be taking part, depending on the safety profile and number of doses tested, at approximately 10 different research sites in 3 countries.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0406
Date of REC Opinion
17 Aug 2015
REC opinion
Further Information Favourable Opinion