Phase 3
Completed N=789
Study of Immunotherapy to Treat Advanced Prostate Cancer
Source: ClinicalTrials.gov NCT00861614 ↗Enrolled (actual)
789
Serious AEs
53.4%
Results posted
Mar 2016
Primary outcomePrimary: Overall Survival (OS) — 11.04; 10.02 months — p=0.0127
Summary
The purpose of the study is to determine if advanced prostate cancer patients that are treated with radiotherapy (RT) plus ipilimumab live longer that those treated with RT alone
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
11.04; 10.02 | 0.0127 sig |
| PRIMARY Overall Survival Rate |
46.5; 40.8; 25.2; 16.6; 15.3; 7.9 | — |
| SECONDARY Progression Free Survival (PFS) |
4.01; 3.06 | — |
| SECONDARY Pain Response |
3.55; 0.54 | — |
| SECONDARY Duration of Pain Response |
2.5; 1.5 | — |
| SECONDARY Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE) and Immune-Mediated Adverse Reaction (imAR) |
257; 164; 296; 180; 346; 371 | — |
| SECONDARY Time to Onset of Grade 3 or 4 Immune-Related Adverse Event (irAE) |
5.71; 5.71; 9.14; 6.00; 3.71; NA | — |
| SECONDARY Time to Resolution of Grade 3 or 4 Immune-Related Adverse Event (irAE) |
2.9; 0.9; 4.1; 6.0; 3.6; NA | — |
| SECONDARY Time to Onset of Grade 3 to 5 Immune-Mediated Adverse Reaction (imAR) |
3.4; 9.0; 2.4; 7.9 | — |
| SECONDARY Time to Resolution of Grade 3 to 5 to Grade 0 Immune-Mediated Adverse Reactions (imARs) to Grade 0 |
6.0; 8.6; 6.9; NA | — |
| SECONDARY Number of Participants With Worst On-Study Hematology Common Toxicity Criteria (CTC) Grade and Shift From Baseline |
3; 2; 0; 1; 0; 1 | — |
| SECONDARY Number of Participants With Worst On-Study Liver Common Toxicity Criteria (CTC) Grade and Shift From Baseline |
16; 1; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Worst On-Study Serum Chemistry Common Toxicity Criteria (CTC) Grade and Shift From Baseline |
21; 10; 1; 1; 1; 0 | — |
| SECONDARY Number of Participants With Worst On-Study Renal Function Common Toxicity Criteria (CTC) Grade and Shift From Baseline |
3; 3; 0; 0; 0; 0 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- Advanced prostate cancer
- At least 1 bone metastasis
- Testosterone < 50 ng/dl
- Prior treatment with docetaxel
Exclusion Criteria
- Brain metastasis
- Autoimmune disease
- Known HIV, Hep B, or Hep C infection
- More than 2 prior systemic anticancer regimens for prostate cancer
- Prior treatment on BMS CA180227 for prostate cancer
Data sourced from ClinicalTrials.gov (NCT00861614). 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.