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 Cancer
MedDRA version: 17.0Level: PTClassification code 10036909Term: Prostate cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2014-002987-34-DE

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 250

Inclusion Criteria

- 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

Exclusion Criteria

- 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;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;Timepoint(s) of evaluation of this end point: approximately 12 months;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.

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