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NCT03179410 · ClinicalTrials.gov registry record · Phase 2
PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer
A Phase 2 study, sponsored by Andrew J. Armstrong, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT03179410: Completed Phase 2 study, sponsored by Andrew J. Armstrong, MD.
NCT03179410 is a Phase 2 study that has completed, run by Andrew J. Armstrong, MD. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03179410, a Phase 2 study, has completed, sponsored by Andrew J. Armstrong, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of avelumab in patients with metastatic neuroendocrine-like prostate cancer. Eligible men will be started on avelumab every 2 weeks and will stay on therapy until progression or intolerable side effects. The central hypothesis is that PD-L1 inhibition with avelumab will be efficacious based on radiographic responses in a subset of men with metastatic neuroendocrine-like prostate cancer and be reasonably well tolerated, meeting criteria for further study in larger phase 2 and 3 trials based on meeting pre-specified efficacy rates and prolonged PFS in some men.
Primary Outcome
Overall response rate is determined by radiographic response assessment utilizing modified Prostate Cancer Working Group 3 (PCWG3) using Immune Response Evaluation Criteria In Solid Tumors Criteria (iRECIST 1.1). iRECIST is the modified RECIST 1.1 for immune-based therapeutics, to measure radiographic response rate in men with metastatic prostate cancer. Patients alive who had not progressed as of the last follow-up, had PFS censored at the last follow-up date. There are five categories overall
Interventions
- DRUG Avelumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2020-12-18 |
| Phase | Phase 2 |
What the finished NCT03179410 record still lists
NCT03179410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 1 intervention - of which Avelumab is the first listed.
NCT03179410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03179410 about?
NCT03179410 is a clinical study titled "PD-L1 Inhibition as ChecKpoint Immunotherapy for NeuroEndocrine Phenotype Prostate Cancer". The purpose of this study is to assess the safety and efficacy of avelumab in patients with metastatic neuroendocrine-like prostate cancer. Eligible men will be started on avelumab every 2 weeks and will stay on therapy until progression or intolerable side effects. The central hypothesis is that PD...
What is the current status of trial NCT03179410?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2018-02-01. Estimated completion is 2020-12-18.
What interventions are being tested in trial NCT03179410?
The interventions under investigation include: Avelumab (DRUG).
Who is sponsoring clinical trial NCT03179410?
This trial is sponsored by Andrew J. Armstrong, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03179410's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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