drugset / Trial / NCT01057810
Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2010-07
- Primary completion
- 2015-04
- Completion
- 2015-07
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Ipilimumab; p = 0.3667; Hazard Ratio (HR) 1.11 (95.87% CI 0.88 to 1.39); Log Rank NCT01057810 ↗
Publications
- de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
- Dayyani F, Gallick GE, Logothetis CJ, Corn PG. Novel therapies for metastatic castrate-resistant prostate cancer. J Natl Cancer Inst. 2011 Nov 16;103(22):1665-75. doi: 10.1093/jnci/djr362. Epub 2011 Sep 13.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 10 mg/kg | Intravenous |