Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)

What Was Tested

The trial (phase 1, phase 2) is built around Degarelix.

The primary objectives are to 1) determine the rate of PSA recurrence defined as a PSA \>0.2ng/ml for radical prostatectomy patients or PSA \>2.0ng/ml for patients who received primary radiation therapy at a time point of 10 months after start of therapy; and 2) determine the safety and tolerability of either nivolumab or nivolumab plus BMS-986253 in combination with degarelix in men with hormone-sensitive prostate cancer.

It had two arms (groups): Arm A: Nivolumab alone (experimental) and Arm B: Nivolumab plus BMS-986253 (experimental).

The registry classes the interventions as drug.

More on the Plan

Once initiated, ADT can be given either continuously or intermittently.

Who Took Part

59 actual participants took part.

It was open to men only aged from 18 years up to 99 years.

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

Examples of who could join: Histologically documented prostatic adenocarcinoma confirmed by a pathology report from prostate biopsy or a radical prostatectomy specimen. Age ≥18 years. Previously undergone primary therapy for prostate cancer. Salvage XRT or cryotherapy following primary therapy ≥ 6 months prior to randomization is allowed. A rising PSA defined as the following:. For the biopsy sub-groups, patients must be willing to undergo pre and on- treatment biopsies.

The full record lists 21 inclusion and 26 exclusion criteria; among the exclusions: PSA \> 50 at time of enrollment; high volume disease defined as \>5 bone metastases or lymph nodes \>3cm in size; received salvage xrt ≤ 6 months prior to randomization.

How the Study Was Run

It was run as a randomized, parallel-group 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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.

It started in 2018-10-11 with completion listed for 2023-09-22.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Prostate-specific Antigen (PSA) Recurrence (time frame: Up to 10 months after completion of therapy, an average of 15 months). Incidence of Adverse Events That Are Serious in Nature and Related to the Investigational Product (time frame: Up to 10 months after completion of therapy, an average of 15 months).

It also tracked 2 secondary outcomes, for example Percentage Change in PSA and Relapse-free Survival (RFS).

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of Degarelix in 59 people.

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

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