CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
Leuprolide Acetate +2 moredrug
Likely dose
Leuprolide Acetate 22.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01194271
NCT01194271Phase 2Completed
CompareCT.gov

A Neoadjuvant Phase IIa Study of Ipilimumab {Formerly Known as MDX-010 (BMS-734016)} Plus Hormone Ablation in Men With Prostate Cancer Followed by Radical Prostatectomy.

M.D. Anderson Cancer Center·interventional·Posted Sep 2, 2010·Updated Jun 6, 2024

In Brief

A Phase 2 clinical trial evaluating Leuprolide Acetate, Ipilimumab, and 1 other intervention for Prostate Cancer. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2, 2010
Enrollment StartSep 1, 2010
Primary CompletionOct 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.8 years ago

Interventions

Leuprolide Acetatedrug

22.5 mg administered as a single intramuscular 3 month depot.

Ipilimumabdrug

10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy.

Radical Prostatectomyprocedure

Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.