Safety and Efficacy study of ipilimumab 3 mg/kg versus ipilimumab 10 mg/kg in subjects with metastatic castration resistant prostate cancer who are chemotherapy naive
- Conditions
- Metastatic Chemotherapy-Naïve Castration Resistant Prostate CancerMedDRA version: 17.0 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-002987-34-GB
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 82
- Prostate cancer with metastases
- Prostate cancer should be castration resistant
- Progression during hormonal therapy
Please see protocol for further information on inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 175
- Visceral metastases (eg liver, lung or brain metastases)
- Prior treatment with any immunotherapy for prostate cancer
- Prior or ongoing cytotoxic therapy for prostate cancer
- Autoimmune disease
- Inadequate hematologic, renal, or hepatic function
Please see protocol for further information on exclusion criteria
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses ( 3 mg/kg and 10 mg/kg) of ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer;<br> Secondary Objective: - To assess the rate of severe irAEs<br> - To assess overall survival<br> - To assess PSA PFS<br> - To assess PSA response<br> - To assess time to pain progression<br> ;Primary end point(s): Radiologic Progression Free Survival: Radiographic PFS (rPFS) is defined as the time from randomization to the earliest date on which either of the following events was documented: radiographic progression (per PCWG2 for bone lesions and modified RECIST 1.1 for non-bone lesions) or death. All radiological progression will be based on investigator assessments.;Timepoint(s) of evaluation of this end point: approximately 12 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Rate of severe immune-related adverse events, Overall survival, Prostate Specific Antigen Progression-free Survival, Prostate Specific Antigen Response Rate, Time to Pain Progression;Timepoint(s) of evaluation of this end point: approximately 36 months