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NCT03689699 · ClinicalTrials.gov registry record · Phase 1
Nivolumab and BMS-986253 for Hormone-Sensitive Prostate Cancer (MAGIC-8)
A Phase 1 study of Prostate Cancer and Adenocarcinoma of the Prostate, sponsored by Mark Stein.
- Active
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 4
- Study locations
NCT03689699: Active Phase 1 study of Prostate Cancer and Adenocarcinoma of the Prostate, sponsored by Mark Stein.
NCT03689699 is a Phase 1 study of Prostate Cancer and Adenocarcinoma of the Prostate that is active but no longer recruiting, run by Mark Stein. The registered enrollment target is 59 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03689699, a Phase 1 study of Prostate Cancer and Adenocarcinoma of the Prostate, is active but no longer recruiting, sponsored by Mark Stein.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
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.
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 |
What the registry record for NCT03689699 still lists
NCT03689699 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (90% lower).
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.
NCT03689699 reports a single indexed study location in New York, Georgia, Pennsylvania.
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.
What interventions are being tested in trial NCT03689699?
The interventions under investigation include: Nivolumab (DRUG), Degarelix (DRUG), BMS-986253 (DRUG).
Who is sponsoring clinical trial NCT03689699?
This trial is sponsored by Mark Stein, which has 4 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT03689699's enrollment target sits among peer trials
59 444th of 735 higher than 290 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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