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NCT04946370 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer
A Phase 1 study of Prostate Cancer, sponsored by Weill Medical College of Cornell University.
- Active
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
- 4
- Study locations
NCT04946370: Active Phase 1 study of Prostate Cancer, sponsored by Weill Medical College of Cornell University.
NCT04946370 is a Phase 1 study of Prostate Cancer that is active but no longer recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 37 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04946370, a Phase 1 study of Prostate Cancer, is active but no longer recruiting, sponsored by Weill Medical College of Cornell University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab + androgen receptor inhibitor (ARI) is more effective against prostate cancer than pembrolizumab + ARI alone.
Primary Outcome
Primary outcome for phase I; DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. There will be 12 weeks of safety follow-up following visit 1.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG 225Ac-J591
- DRUG Androgen receptor inhibitor
- DIAGNOSTIC_TEST 68Ga-PSMA-11
Study Locations (4)
New York
- New York Presbyterian/Brooklyn Methodist Hospital - Brooklyn
- New York Presbyterian/Weill Cornell Medical Center - New York
- Columbia University Irving Cancer Center - New York
Massachusetts
- Dana-Farber Cancer Institute - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2021-08-12 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
What the registry record for NCT04946370 still lists
NCT04946370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT04946370 reports a single indexed study location in New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04946370 about?
NCT04946370 is a clinical study titled "Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer". This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab...
What is the current status of trial NCT04946370?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2021-08-12. Estimated completion is 2029-12.
What conditions does trial NCT04946370 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT04946370?
The interventions under investigation include: Pembrolizumab (DRUG), 225Ac-J591 (DRUG), Androgen receptor inhibitor (DRUG), 68Ga-PSMA-11 (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04946370?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04946370 being conducted?
This trial has 4 study locations across Massachusetts, 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 NCT04946370's enrollment target sits among peer trials
37 541st of 735 higher than 193 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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