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Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
NCT03689699 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Degarelix
- DRUG BMS-986253
Study Locations (4)
New York
- Weill Cornell Medical Center — New York
- Columbia University Irving Medical Center — New York
Georgia
- Winship Cancer Institute, Emory University — Atlanta
Pennsylvania
- Sidney Kimmel Cancer Center- Thomas Jefferson University — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2018-10-11 |
| Est. Completion | 2026-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03689699
The ClinicalTrials.gov registry entry for NCT03689699 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 59 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mark Stein, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03689699 reports 4 study locations spanning 3 distinct geographic areas — top geographies include New York, Georgia, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03689699 about?
NCT03689699 is a clinical study titled "Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)". 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). ...
What is the current status of trial NCT03689699?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2018-10-11. Estimated completion is 2026-01.
What conditions does trial NCT03689699 study?
This clinical trial studies the following conditions: Prostate Cancer, Adenocarcinoma of the Prostate. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03689699?
The interventions under investigation include: Nivolumab (DRUG), Degarelix (DRUG), BMS-986253 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03689699?
This trial is sponsored by Mark Stein, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03689699 being conducted?
This trial has 4 study locations across Georgia, New York, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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