Randomised Phase II study in untreated advanced renal cell carcinoma
Research type
Research Study
Full title
A PHASE II, RANDOMIZED STUDY OF MPDL3280A ADMINISTERED AS MONOTHERAPY OR IN COMBINATION WITH BEVACIZUMAB VERSUS SUNITINIB IN PATIENTS WITH UNTREATED ADVANCED RENAL CELL CARCINOMA
IRAS ID
137837
Contact name
Thomas Powles
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd
Eudract number
2013-003167-58
ISRCTN Number
N/A
Research summary
The purpose of this study is to test the effectiveness of an experimental drug called MPDL3280A, given by itself or with another medicine called bevacizumab, in patients with kidney cancer, compared with another standard medicine called sunitinib.
Approximately 150 patients will take part in this study at approximately 50 to 100 study centres globally. To participate, patients must be 18 years or older with kidney cancer that is advanced or metastatic (i.e., their cancer is extensive or has spread) that has not yet been treated with chemotherapy or other anti cancer medicines.
Patients would first need to go through some checks to see if they are eligible to participate (‘screening’) for up to 1 month. Patients who are eligible will be randomly assigned to receive treatment with: a) MPDL3280A plus bevacizumab, b) MPDL3280A alone, or c) sunitinib. Length of study treatment for each participant will depend on which treatment they are assigned to and when their disease gets worse, but total length of time in the study, including the screening, treatment, and follow up periods, will be about 14 months. Patients on treatments b) or c) may be able to cross over to treatment a) after their disease progresses. Patients who do this may be on the study for up to approximately 30 months.
Assessments for the study will include physical examinations, blood and urine samples, ECG (electrocardiograms), tumour biopsy, CT and possibly other types of scans.
The study is sponsored by F. Hoffmann-La Roche Ltd. The study is being run at centres worldwide, including about 4 hospitals in the UK.REC name
London - Riverside Research Ethics Committee
REC reference
14/LO/0022
Date of REC Opinion
16 Jan 2014
REC opinion
Favourable Opinion