Ipilimumab 3 vs 10 mg/kg in chemotherapy naive prostate cancer patient
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind Study of Ipilimumab Administered at 3 mg/kg vs 10 mg/kg in Adult Subjects with Metastatic Chemotherapy-Naïve Castration Resistant Prostate Cancer Who are Asymptomatic or Minimally Symptomatic Pharmacogenetics Blood Sample Amendment Number 01
IRAS ID
166226
Contact name
Rob Jones
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2014-002987-34
Duration of Study in the UK
3 years, 9 months, 12 days
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 is not always started 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 typical 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 compare how well two different doses of ipilimumab works in patients with prostate cancer who are no longer responding to hormone therapy (castration resistant). The study will look at how safe ipilimumab is, and how well it works.
Approximately 200 patients in total are expected to participate in this study, with about 24 patients taking part in the UK. Patients will be assigned 1:1 to either a 3 mg/kg or 10 mg/kg ipilimumab treatment. Ipilimumab is given via a 6-100 minute infusion every 3 weeks for a total of 4 infusions, then every 12 weeks for a maximum of 3 years or until treatment stopping criteria are met, unacceptable side effects are experienced or the patient wishes to withdraw. Patients who withdraw from treatment will be followed up. During the study, if there is a spread or growth of cancer, this 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, and be asked to fill in questionnaires about pain, well-being and health.
The research is funded by Bristol-Myers Squibb, and is being conducted globally.
REC name
West of Scotland REC 1
REC reference
14/WS/1133
Date of REC Opinion
22 Dec 2014
REC opinion
Further Information Favourable Opinion