Ipilimumab vs placebo after radiotherapy in prostate cancer patients
Research type
Research Study
Full title
A Randomized, Double-Blind, Phase 3 Trial Comparing Ipilimumab vs. Placebo Following Radiotherapy in Subjects with Castration Resistant Prostate Cancer That Have Received Prior Treatment with Docetaxel
IRAS ID
25592
Contact name
Santhanam Sundar
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2008-003314-97
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Prostate cancer is one of the most common cancers in men in the UK. In many patients with advanced prostate cancer, the cancer can spread to the bone (called bone metastases) causing severe symptoms. Standard treatment for these patients is with drugs such as docetaxel and prednisone/prednisolone. However, most patients progress and are given further treatment to help reduce bone pain and other symptoms as well as to try and prevent the cancer from spreading and growing. The purpose of this study is to determine the safety and efficacy of radiotherapy followed by the monoclonal antibody ipilimumab, an investigational drug, to see whether this treatment combination improves overall survival and the patient??s pain symptoms, compared to dummy treatment (placebo). This will be done in patients who currently have prostate cancer and require further treatment. Approximately 800 patients in total are expected to participate in this study, with about 18 patients taking part in the UK. Patients will be assigned 1:1 to either ipilimumab 10 mg/kg treatment or placebo. Treatment will start after radiotherapy is given. Ipilimumab is given via a 90 minute infusion every 3 weeks for a total of 4 infusions, then every 12 weeks until treatment stopping criteria are met, unacceptable side effects are experienced or the patient wishes to withdraw from treatment. Patients who withdraw from treatment will be followed up. During the study, the spread or growth of cancer will be assessed by regular CT and bone scans. Patients will undergo physical examinations and have blood samples taken at all study visits. Patients will also have urine taken, their weight and vital signs measured at some visits. The research is funded by Bristol-Myers Squibb, and is being conducted in Europe, North America, Canada and Australia. Enrolment starts in summer 2009 and will continue until summer 2012.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
09/H0206/48
Date of REC Opinion
19 Nov 2009
REC opinion
Further Information Favourable Opinion