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

  • STATUS
    Recruiting
  • End date
    May 4, 2024
  • participants needed
    24
  • sponsor
    Matthew Dallos
Updated on 4 November 2021

Summary

The purpose of this study is to see whether immunotherapy with BMS-986218 added to degarelix (which suppresses testosterone) given prior to surgery can decrease the chance that cancer will come back compared to degarelix alone. 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.

Description

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). Our 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.

Details
Condition Prostate Cancer, Prostatic disorder, Prostate Disorders, prostate carcinoma, Malignant neoplasm of prostate, prostate cancers, Prostate Cancer, Early, Recurrent
Treatment Degarelix, BMS-986218 and Degarelix
Clinical Study IdentifierNCT04301414
SponsorMatthew Dallos
Last Modified on4 November 2021

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