In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. TPS4691-TPS4691
Abstract:
TPS4691 Background: Ipilimumab (Ipi), a fully human monoclonal antibody which blocks CTLA-4, augments antitumor immune responses. Ipi has demonstrated overall survival (OS) benefit in two Phase 3 trials for advanced melanoma, with side effects that were managed using product-specific treatment guidelines. In addition, in Phase 1/2 trials in metastatic CRPC, Ipi has shown clinical activity (as measured by prostate-specific antigen [PSA] declines and RECIST response) with no unexpected toxicities. While docetaxel is standard therapy for metastatic CRPC, its use may be delayed until pts develop symptoms. As such, this global (~150 sites in 25 countries) Phase 3 study (ClinicalTrials.gov identifier: NCT01057810) is evaluating Ipi vs placebo in chemotherapy-naïve pts with asymptomatic or minimally symptomatic CRPC without visceral metastases. Methods: The primary endpoint is OS; secondary endpoints include progression-free survival, time to pain progression, and time to non-hormonal systemic therapy. The study is designed to detect a 9.3 month difference (HR=0.7) in OS with 90% power and 0.05 two-sided significance. Pts are randomized at a 2:1 ratio to receive Ipi 10 mg/kg every 3 weeks for up to 4 doses or placebo, respectively, as induction therapy. Eligible pts will continue to receive maintenance therapy of blinded study drug every 12 weeks until treatment stopping criteria are met, withdrawal of consent, or study closure. The accrual goal is 600 pts randomized. [Table: see text] [Table: see text]
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.tps4691
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
Permalink