Non-fucosylated Anti-CTLA-4 (BMS-986218) + Degarelix Acetate vs. Degarelix Acetate Alone in Men With High-risk Localized Prostate Cancer

What Was Tested

The trial (early phase 1) is built around Degarelix.

People who usually have this type of prostate cancer usually do not receive any additional therapy prior to surgery.

Approximately 24 individuals will be asked to participate in this study.

It had three arms (groups): Safety lead-in (other), Arm A (active comparator) and Arm B (experimental).

The first 4 subjects enrolled will be given degarelix plus BMS-986218.

The registry classes the interventions as drug.

More on the Plan

This is a single-center, randomized, two-arm, study evaluating the safety, feasibility and immunogenicity of neoadjuvant degarelix(Arm A) or BMS-986218 plus degarelix (Arm B) prior to radical prostatectomy in men with high-risk localized prostate cancer (neo-RED-P).

Their primary objective is to characterize safety, tolerability, and feasibility of degarelix with or without BMS-986218 in the neoadjuvant setting.

The trial will monitor toxicity and safety, as well as surgery related adverse events.

The secondary objectives will be to evaluate an immune response consistent with the proposed mechanism of action of BMS-986218, depletion of Tregs, and to assess the pathologic complete response rate, PSA response rate and time-to-PSA recurrence following treatment.

Who Took Part

Enrollment: 26 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: Histologically confirmed adenocarcinoma of the prostate (clinical stage T1c-T3b, N0, M0) without involvement of lymph nodes, bone, or visceral organs. Initial prostate biopsy is available for central pathologic review, and is confirmed to show at least 2 positive cores and a Gleason sum of ≥4+3. Age ≥18 years. Adequate bone marrow, hepatic, and renal function:. White blood cell count (WBC) \>3,000 cells/mm3.

The full record lists 17 inclusion and 24 exclusion criteria; among the exclusions: presence of known lymph node involvement or distant metastases; other histologic types of prostate cancers such as ductal, sarcomatous, lymphoma, small cell, and neuroendocrine tumors; prior radiation therapy, hormonal therapy, biologic therapy, or chemotherapy for prostate cancer.

How the Study Was Run

It was run as a randomized, sequential and open-label study.

Because people in this Degarelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

It started in 2020-02-25 with completion listed for 2025-03-13.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Undetectable PSA at 12 months- the proportion of patients who achieve an undetectable PSA (<0.1 ng/mL) by 12 months after prostatectomy.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Degarelix in 26 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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