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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Mark Stein
Study ID
NCT03689699
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    A dose of 480mg every 4 weeks as a 30 minute IV infusion for 6 doses has been selected for this study. 6 total doses.
  • Degarelix — DRUG
    Standard treatment at a dose of 240mg subcutaneously (SQ) as a loading dose followed by 80mg SQ every 4 weeks for 4 doses.
  • BMS-986253 — DRUG
    BMS-986253 (also referred to as anti-IL8 mAb or HuMax IL8) is a fully human-sequence IgG1κ monoclonal antibody (mAb) directed against human interleukin-8 (IL-8). Subjects will be treated with an intravenous (IV) flat dose of 2400mg every 2 weeks.

Study Details

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.

Key Dates

Start date
Oct 11, 2018
Status verified
Apr 2025
Primary completion
Sep 22, 2023
Completion
Jan 31, 2026

Study Design

Enrollment
59 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Nivolumab alone
    Men with hormone-sensitive prostate cancer will receive Nivolumab alone every 4 weeks for 8 weeks (2 doses), followed by Nivolumab + Degarelix every 4 weeks for 16 weeks (4 doses).
  • Experimental: Arm B: Nivolumab plus BMS-986253
    Men with hormone-sensitive prostate cancer will receive Nivolumab plus BMS-986253 every 4 weeks for 8 weeks (2 doses), followed by Nivolumab + BMS-986253 + Degarelix every 4 weeks for 16 weeks (4 doses).

Primary Outcome Measure

Number of Participants With Prostate-specific Antigen (PSA) Recurrence [ Time Frame: Up to 10 months after completion of therapy ]

Locations (4)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute, Emory UniversityAtlantaGeorgia30322-
Columbia University Irving Medical CenterNew YorkNew York10032-
Weill Cornell Medical CenterNew YorkNew York10021-
Sidney Kimmel Cancer Center- Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-

Related coverage on Hipa.ai

Find similar trials in Atlanta, GA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Winship Cancer Institute, Emory University· Atlanta, GAColumbia University Irving Medical Center· New York, NYWeill Cornell Medical Center· New York, NYSidney Kimmel Cancer Center- Thomas Jefferson University· Philadelphia, PA

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