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

StatusCompleted
PhasePhase 1/2
SponsorMark Stein
Started

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Record History

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  1. Trial completed
    • Study completion date changed from estimate of Jan 2026 to May 2, 2024
    • Eligibility criteria expanded, about 47 words
    • Secondary endpoints: details revised at 1 of 2 entries
  2. Results first posted: Apr 29, 2025v8 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: estimated 60 to confirmed 59
    • Primary completion date changed from estimate of May 2024 to Sep 22, 2023
    • Study completion date: Jan 2025 to Jan 2026
    • Secondary endpoints revised (2)
  3. Primary completion date: Oct 2023 to May 2024
    • Study completion date: Dec 2023 to Jan 2025
    v7
  4. Lead sponsor: Matthew Dallos to Mark Steinv6 Show 5 more changesShow less
    • Primary completion date: Jan 2023 to Oct 2023
    • Primary endpoints revised (2)
    • Study sites: 3 to 4
    • Study completion date: Aug 2023 to Dec 2023
    • Eligibility criteria expanded, about 16 words
  5. Primary completion date: Jan 2022 to Jan 2023v5 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Trial status: Recruiting to Active, Not Recruiting
    • Eligibility criteria expanded, about 244 words
    • Study sites revised (3)
Show 3 earlier versionsHide 3 earlier versions
  1. Lead sponsor: Charles G. Drake to Matthew Dallos
    • Primary completion date: Jan 2020 to Jan 2022
    • Study completion date: Aug 2022 to Aug 2023
    • Site contacts updated at 1 of 3 sites
    v4
  2. Start date changed from estimate of Mar 2019 to Oct 11, 2018
    • Site details revised at 2 of 3 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2018 to Mar 2019
    • Study description revised
    • Site details revised at 3 of 3 sites
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
MAGIC-8 is a two-arm, multicenter, phase 1b/2 study to assess the efficacy of immunotherapy with either Nivolumab (anti-PD-1) or Nivolumab plus BMS-986253 combined with ADT using Degarelix (LHRH antagonist) for men with hormone-sensitive prostate cancer and a rising prostate-specific antigen (PSA). The purpose of this study is to see whether immunotherapy with either Nivolumab alone or Nivolumab plus BMS-986253 combined with Degarelix, which suppresses testosterone, is safe and can decrease the chance that the cancer will come back. 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. The secondary objectives include determining relapse-free survival (RFS) and % change in PSA to immunotherapy alone.
Trial Details
NCT Number NCT03689699
Lead Sponsor Mark Stein
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Prostate Cancer, Adenocarcinoma of the Prostate
Related terms Prostatic Neoplasms
Enrollment 59 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov