Phase 3
Completed N=598
Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
Source: ClinicalTrials.gov NCT01057810 ↗Enrolled (actual)
598
Serious AEs
44.5%
Results posted
Aug 2016
Primary outcomePrimary: Overall Survival (OS) Time — 29.73; 28.65 months — p=0.3667
◆ Published Evidence
Highly cited
134citations · ~9 / year
Novel therapies for metastatic castrate-resistant prostate cancer.
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
Linked Publications (2)
-
Novel therapies for metastatic castrate-resistant prostate cancer.
-
Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer.
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 | — |
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) and the linked publication. 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.