CA209-214 Nivolumab combined with Ipilimumab versus Sunitinib in RCC
Research type
Research Study
Full title
A Phase 3, Randomized, Open-Label Study of Nivolumab Combined with Ipilimumab Versus Sunitinib Monotherapy in Subjects with Previously Untreated, Advanced or Metastatic Renal Cell Carcinoma
IRAS ID
159185
Contact name
Head of Global Submission Management - Clinical Trials
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-001750-42
Research summary
This is a multicentre, phase 3 study involving an investigational drug called Nivolumab given in combination with Ipilimumab compared to Sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). The purpose of this study is to find out if patients with untreated advanced RCC, survive for longer on Nivolumab and Ipilimumab when compared to Sunitinib.
Kidney cancer accounts for 2% of all cancers worldwide. RCC is the most common type of kidney cancer in adults
(80% of cases). A significant number of RCC patients have advanced or metastatic (cancer which has spread to other parts of the body) cancer at diagnosis and unfortunately the survival rate is poor.
Approximately 1355 patients will take part, approximately 68 coming from the UK. Following a screening period, eligible patients will receive either Nivolumab + Iplimumab given intravenously (through a vein) or Sunitinib which is taken orally. Patients and doctors will know what medication they have been assigned to. Patients will undergo the following study procedures: CT/MRI scans, ECG, ECHO or MUGA scan, physical exams, vital signs such as BP checks, height, weight, body temperature, oxygen levels and blood samples for routine safety testing and study specific testing. Participants will also be required to complete a questionnaire about their RCC symptoms at regular intervals throughout the study. Patients can remain on the study for as long as they are tolerating the treatment or until it has been confirmed that their cancer has worsened. At the conclusion of the study patients who continue to gain clinical benefit may be eligible to continue to receive study drug. The expected duration of participation may be up to 5 years.Lay summary of study results: Lay summary of study results will be provided to the Investigators to pass on to the patients in the form of plain language summary (PLS).
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/1292
Date of REC Opinion
20 Oct 2014
REC opinion
Further Information Favourable Opinion