Neoadjuvant Ipilimumab in Prostate Cancer

What Was Tested

The trial (phase 2) is built around Leuprolide.

It had 1 arm (groups): Neoadjuvant Ipilimumab (experimental).

The registry classes the interventions as drug and procedure.

More on the Plan

The Study Drugs: Ipilimumab is designed to cause an immune response in your body by blocking 2 specific molecules that usually block an immune response.

Leuprolide acetate is designed to lower the level of testosterone (a male hormone) in the blood.

Study Drug Administration: If you are found to be eligible to take part in this study, you will receive a leuprolide acetate injection in your muscle.

This is considered Week 0.

Who Took Part

Enrollment: 19 actual participants took part.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Willing and able to give written informed consent;. Determination of high-risk status: Patients must have either: 1) a Prostate biopsy Gleason sum \>/= 8 OR 2) PSA \>/= 20. ECOG performance status of 0 or 1;. Men \>/= 18 years of age. Patients must agree to practice barrier birth control methods while on therapy, prior to surgery.

The full record lists 10 inclusion and 11 exclusion criteria; among the exclusions: known hiv or chronic hepatitis; previous treatment with other investigational products within 30 days;; previous enrollment in another mdx-010 (bms-734016) clinical trial or prior treatment with a cd137 agonist or ctla-4 inhibitor or agonist.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-09 with completion listed for 2015-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Immunologic Response: Number of Participants With Immune Response (time frame: Baseline to Week 8).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Leuprolide in 19 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Leuprolide compound page, all human trials.