Phase 3
N=598
Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
Prostate Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01057810 ↗Enrolled (actual)
598
Serious AEs
44.5%
Results posted
Aug 2016
Primary outcome: Primary: Overall Survival (OS) Time — 29.73; 28.65 months — p=0.3667
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ipilimumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) Time |
29.73; 28.65 | 0.3667 |
| SECONDARY Progression-Free Survival (PFS) Time |
3.81; 5.59 | — |
| SECONDARY Time to Subsequent Non-hormonal Cytotoxic Therapy |
10.91; 18.04 | — |
| SECONDARY Time to Pain Progression |
16.62; 21.68 | — |
| SECONDARY Number of Participants Who Died or Had Adverse Events (AEs), Serious Adverse Events (SAEs), Immune-related AEs (irAEs), or Immune-mediated Adverse Reactions (imARs) |
59; 223; 98; 325; 11; 158 | — |
| SECONDARY Number of Treated Participants With Grade 3 or 4 Clinical Laboratory Abnormalities |
0; 3; 0; 2; 0; 2 | — |
Summary
The purpose of this study is to determine if asymptomatic or minimally symptomatic patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria
- Metastatic prostate cancer
- Asymptomatic or minimally symptomatic
- Progression during hormonal therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
Exclusion Criteria
- Liver, lung or brain metastases
- Prior immunotherapy or chemotherapy for metastatic prostate cancer
- Autoimmune disease
- HIV, Hepatitis B, or Hepatitis C infection
Data sourced from ClinicalTrials.gov (NCT01057810). 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.