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ACTIVE NOT RECRUITING
NCT03689699
PHASE1/PHASE2

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

Sponsor: Mark Stein

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Phase 1b/2 Study of Nivolumab or Nivolumab Plus BMS-986253 in Combination With Intermittent Androgen Deprivation Therapy in Men With Hormone-Sensitive Prostate Cancer

Key Details

Gender

MALE

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

59

Start Date

2018-10-11

Completion Date

2026-01

Last Updated

2025-04-29

Healthy Volunteers

No

Interventions

DRUG

Nivolumab

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.

DRUG

Degarelix

Standard treatment at a dose of 240mg subcutaneously (SQ) as a loading dose followed by 80mg SQ every 4 weeks for 4 doses.

DRUG

BMS-986253

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.

Locations (4)

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

Weill Cornell Medical Center

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

Sidney Kimmel Cancer Center- Thomas Jefferson University

Philadelphia, Pennsylvania, United States