Phase 2
Completed N=53
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
Source: ClinicalTrials.gov NCT02279862 ↗Enrolled (actual)
53
Serious AEs
41.2%
Results posted
Jul 2018
Primary outcomePrimary: Radiographic Progression-free Survival (rPFS) — 4; 3 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiographic Progression-free Survival (rPFS) |
4; 3 | — |
| SECONDARY Number of Participants Who Experienced Immune-related Adverse Events (irAEs) |
13; 18 | — |
| SECONDARY Overall Survival (OS) |
4; 6 | — |
| SECONDARY Prostate Specific Antigen Progression-free Survival (PSA PFS) |
4; 3 | — |
| SECONDARY Time to Pain Progression |
0; 1 | — |
| SECONDARY Prostate Specific Antigen Response Rate |
0; 1 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Prostate cancer with metastases
- Prostate cancer should be castration resistant
- Progression during hormonal therapy
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
Data sourced from ClinicalTrials.gov (NCT02279862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.