Ipilimumab vs placebo in chemotherapy naive Prostate Cancer patients
Research type
Research Study
Full title
Randomised, Double-Blind, Phase 3 Trial to Compare the Efficacy of Ipilimumab vs Placebo in Asymptomatic or Minimally Symptomatic Patients with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer
IRAS ID
48939
Contact name
Robert (Rob) Jones
Contact email
Sponsor organisation
Bristol−Myers Squibb International Corporation
Eudract number
2009-016217-23
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 metastatic prostate cancer, the cancer can be slow growing in type and patients experience no or minimal symptoms. Treatment with chemotherapy is not necessarily appropriate at this stage. Treating doctors may decide to watch and wait and keep a close eye on the patient to see if the cancer and symptoms begin to develop. It is envisaged that most patients will subsequently receive chemotherapy, in line with standard care, when it is clinically appropriate to do so. The purpose of this study is to determine if patients with prostate cancer who are no longer responding to hormone therapy (castration resistant) who have not received chemotherapy live longer when treated with ipilimumab, an investigational drug, than those treated with a dummy treatment (placebo). The study will look at how safe ipilimumab is and how well it works. Approximately 600 patients in total are expected to participate in this study, with about 30 patients taking part in the UK. Patients will be assigned 2:1 to either ipilimumab 10 mg/kg treatment or placebo. 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 globally with enrolment starting in summer 2010, continuing until summer 2012.
REC name
West of Scotland REC 1
REC reference
10/S0703/23
Date of REC Opinion
19 May 2010
REC opinion
Further Information Favourable Opinion