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NCT04926181 · ClinicalTrials.gov registry record · Phase 2
Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer
A Phase 2 study, sponsored by Rahul Aggarwal.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT04926181: Clinical Trial Phase 2 study, sponsored by Rahul Aggarwal.
NCT04926181 is a Phase 2 study that was terminated before completion, run by Rahul Aggarwal. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04926181, a Phase 2 study, was terminated before completion, sponsored by Rahul Aggarwal.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Despite the low androgen receptor (AR) transcriptional activity of treatment-emergent small cell neuroendocrine prostate cancer, there is persistent AR expression observed in the majority of treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) biopsies. This indicates that epigenetic dysregulation leads to reprogramming away from an AR-driven transcriptional program. Therefore, continuation of AR blockade in the form of apalutamide may provide additive benefit compared to immune checkpoint blockade alone. The investigators hypothesize that the combination of apalutamide plus cetrelimab will achieve a clinically significant composite response rate with sufficient durability of response in mCRPC patients with evidence of treatment-emergent small cell neuroendocrine prostate cancer
Primary Outcome
The composite response rate is determined by a combination of a decline from baseline in serum PSA of \>= 50%, confirmed by repeat measurement ≥ 4 weeks later (PSA50) AND a complete response (CR) or partial response (PR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria confirmed by repeat scan ≥ 4 weeks later.
Interventions
- DRUG Apalutamide
- BIOLOGICAL Cetrelimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2022-03-16 |
| Est. Completion | 2024-03-31 |
| Phase | Phase 2 |
Why NCT04926181 stopped before completion
NCT04926181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Apalutamide is the first listed.
NCT04926181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04926181 about?
NCT04926181 is a clinical study titled "Apalutamide Plus Cetrelimab in Patients With Treatment-Emergent Small Cell Neuroendocrine Prostate Cancer". Despite the low androgen receptor (AR) transcriptional activity of treatment-emergent small cell neuroendocrine prostate cancer, there is persistent AR expression observed in the majority of treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC) biopsies. This indicates that epigeneti...
What is the current status of trial NCT04926181?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2022-03-16. Estimated completion is 2024-03-31.
What interventions are being tested in trial NCT04926181?
The interventions under investigation include: Apalutamide (DRUG), Cetrelimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04926181?
This trial is sponsored by Rahul Aggarwal, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04926181's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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