CA209-9ER: Advanced or Metastatic Renal Cell Carcinoma
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Cabozantinib versus Sunitinib in Participants with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
IRAS ID
227616
Contact name
Thomas Powles
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-000759-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 0 days
Research summary
This study is a multi-centre phase 3 study involving investigational drugs nivolumab, ipilimumab and cabozanitib in patients 18 years or older who have not yet received any treatment for their advanced or metastatic kidney cancer. Approximately 1014 patients will be treated in the study globally, with approximately 16 patients in the UK. The study is sponsored by Bristol-Myers Squibb Pharmaceuticals Ltd.
Renal cell cancer is the eight most common cancer in the world with the incidence increasing. Despite the early detection and surgical removal of small kidney tumors, the death rate due to this cancer is increasing and there is a need to improve management of this disease.
The purpose of this study is to find out if nivolumab combined with cabozantinib (two study treatments) or nivolumab and ipilimumab combined with cabozantinib (three study treatments) will improve outcomes for patients with advanced or metastatic kidney cancer when compared with sunitinib, a well-known standard of care.Nivolumab and ipilimumab are types of immunotherapy treatments which work by helping the body's own immune system to attack the cancer cells. Both are given intravenously (through the vein).
Cabozantinib and subitinib are small molecule tyrosine kinase inhibitors that work by slowing down cancer cell growth and cutting off the blood supply the cancer needs. These are taken orally (swallowed).
Following a screening period, eligible patients will be randomly assigned to receive nivolumab combined with cabozantinib (doublet regimen), or nivolumab and ipilimumab combined with cabozantinib (triplet regimen), or sunitinib. Treatment will continue until the patient's disease status changes (nivolumab can be given for a maximum of 2 years).
Patients will undergo the following procedures during the study: CT/MRI scan, ECG, heart scan (ECHO or MUGA), physical examinations, blood and urine sampling for safety, drug levels, biomarkers and pregnancy testing.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
17/SC/0526
Date of REC Opinion
6 Nov 2017
REC opinion
Further Information Favourable Opinion