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NCT03951831 · ClinicalTrials.gov registry record · Phase 2
REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer
A Phase 2 study of Prostate Cancer Metastatic, sponsored by Mark Stein.
- Active
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03951831: Active Phase 2 study of Prostate Cancer Metastatic, sponsored by Mark Stein.
NCT03951831 is a Phase 2 study of Prostate Cancer Metastatic that is active but no longer recruiting, run by Mark Stein. The registered enrollment target is 26 participants, below the 226-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03951831, a Phase 2 study of Prostate Cancer Metastatic, is active but no longer recruiting, sponsored by Mark Stein.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly metastatic, hormone-sensitive prostate cancer (mHSPC), using a primary endpoint of undetectable prostate-specific antigen (PSA) at 6 months, defined from start of combination therapy (week 10) until 6 months (week 37).
Primary Outcome
The percentage of subject achieving undetectable PSA levels at 6 months after the combination will use measured to determine safety and activity of combined hormonal chemoimmunotherapy.
Conditions Studied
Interventions
- DRUG Docetaxel
- DRUG Degarelix
- DRUG Leuprolide Acetate
- DRUG REGN2810
Study Locations (1)
New York
- Columbia University Irving Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-05-16 |
| Est. Completion | 2028-04 |
| Phase | Phase 2 |
What the registry record for NCT03951831 still lists
NCT03951831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 226-participant average among 17 other Prostate Cancer Metastatic trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Prostate Cancer Metastatic appearing as the primary indexed condition, and to 4 interventions - of which Docetaxel is the first listed.
NCT03951831 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT03951831 about?
NCT03951831 is a clinical study titled "REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer". The primary objective is to determine the safety and activity of combined hormonal chemoimmunotherapy in a single-arm phase II trial of REGN2810, androgen deprivation therapy (ADT), and docetaxel in patients with newly metastatic, hormone-sensitive prostate cancer (mHSPC), using a primary endpoint o...
What is the current status of trial NCT03951831?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-05-16. Estimated completion is 2028-04.
What conditions does trial NCT03951831 study?
This clinical trial studies the following conditions: Prostate Cancer Metastatic.
What interventions are being tested in trial NCT03951831?
The interventions under investigation include: Docetaxel (DRUG), Degarelix (DRUG), Leuprolide Acetate (DRUG), REGN2810 (DRUG).
Who is sponsoring clinical trial NCT03951831?
This trial is sponsored by Mark Stein, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03951831 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03951831's enrollment target sits among peer trials
26 16th of 17 higher than 2 of 17 other Prostate Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer Metastatic 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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