ADAPTeR
Research type
Research Study
Full title
A phase II study of Anti-PD1 (nivolumab) therapy as pre and post operative therapy in metastatic renal cell cancer (ADAPTeR)
IRAS ID
154244
Contact name
James Larkin
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2014-001901-42
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Renal cell carcinoma (RCC) is diagnosed in around 8500 patients annually in the UK. Approximately one third of these patients present with metastatic disease where the RCC has spread to other organs. The mainstay of treatment for these patients is systemic drug therapy, but surgery to remove the primary kidney tumour (i.e. nephrectomy) may also provide clinical benefit.
There is no standard pre-operative systemic drug therapy in metastatic RCC, but such pre-operative therapy is used widely in the treatment of other cancer types. This approach has several potential advantages including shrinking the tumour to help improve surgical outcomes and to aid identification of appropriate post-operative drug therapy.
Over the last 10 years several agents have demonstrated promising activity in RCC including the monoclonal antibody therapy nivolumab. This novel immunotherapy works by blocking an immune cell receptor (programmed death-1( PD-1)) which the cancer can otherwise utilise to evade an individuals immune system attack.
This study will investigate the use of nivolumab therapy as a pre-operative treatment in patients with metastatic RCC for whom nephrectomy is planned. A total of 19 patients will be recruited at the Royal Marsden Hospital Patients will be treated with nivolumab for 8 weeks prior to surgery, after which nivolumab therapy will restart and continue until such time that the patient is not receiving an overall clinical benefit.
The primary aim of the study will be to assess the safety of such a strategy, with further aims to assess clinical effectiveness. This is also a unique opportunity to further investigate the way in which nivolumab works and to identify predictors of treatment response. To achieve this patients will be asked to provide biopsy samples of their RCC pre & post nivolumab treatment and their nephrectomy tissue for research use, alongside additional blood & urine samples.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1181
Date of REC Opinion
1 Dec 2014
REC opinion
Further Information Favourable Opinion