MedTrace Logo

Neoadjuvant Ipilimumab in Prostate Cancer

NCT01194271 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-06-06

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Leuprolide Acetate

22.5 mg administered as a single intramuscular 3 month depot.

DRUG

Ipilimumab

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

PROCEDURE

Radical Prostatectomy

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

Sponsors & Collaborators

Principal Investigators

  • Padmanee Sharma, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01194271 on ClinicalTrials.gov