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NCT04709276 · ClinicalTrials.gov registry record · Phase 2
A Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer
A Phase 2 study of Metastatic Prostate Cancer and Metastatic Prostate Neuroendocrine Carcinoma, sponsored by Andrew J. Armstrong, MD.
- Active
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
- 3
- Study locations
NCT04709276: Active Phase 2 study of Metastatic Prostate Cancer and Metastatic Prostate Neuroendocrine Carcinoma, sponsored by Andrew J. Armstrong, MD.
NCT04709276 is a Phase 2 study of Metastatic Prostate Cancer and Metastatic Prostate Neuroendocrine Carcinoma that is active but no longer recruiting, run by Andrew J. Armstrong, MD. The registered enrollment target is 41 participants, below the 186-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04709276, a Phase 2 study of Metastatic Prostate Cancer and Metastatic Prostate Neuroendocrine Carcinoma, is active but no longer recruiting, sponsored by Andrew J. Armstrong, MD.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of a combination of nivolumab, ipilimumab, cabazitaxel and carboplatin in men with neuroendocrine prostate cancer (NEPC) or other aggressive variants of prostate cancer (AVPC). This study will also investigate biomarkers to gain a better understanding of how the drug combination of nivolumab, ipilimumab, cabazitaxel and carboplatin affects these types of prostate cancer and the immune system. Eligible subjects will receive up to 10 cycles of nivolumab, ipilimumab, carboplatin and cabazitaxel followed by maintenance nivolumab and ipilimumab. Subjects may continue receiving study drugs until cancer progression, severe toxicity, withdrawal of consent, 3 years from the initial dose of study drugs or study termination, whichever occurs earlier. Subjects will be followed for 3 years from the initial dose of study drugs.
Primary Outcome
Progression-free survival will be determined by immune modified or Prostate Cancer Working Group 3 (PCWG3)-defined RECIST 1.1 radiographic criteria.
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Cabazitaxel
Study Locations (3)
New York
- Weill Cornell Medicine - New York
North Carolina
- Duke University Medical Center - Durham
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2021-06-07 |
| Est. Completion | 2028-08 |
| Phase | Phase 2 |
What the registry record for NCT04709276 still lists
NCT04709276 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 186-participant average among 41 other Metastatic Prostate Cancer trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Metastatic Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which Carboplatin is the first listed.
NCT04709276 reports a single indexed study location in New York, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT04709276 about?
NCT04709276 is a clinical study titled "A Study of Chemoimmunotherapy for the Treatment of Men With Neuroendocrine or Aggressive Variant Metastatic Prostate Cancer". The purpose of this study is to evaluate the safety and efficacy of a combination of nivolumab, ipilimumab, cabazitaxel and carboplatin in men with neuroendocrine prostate cancer (NEPC) or other aggressive variants of prostate cancer (AVPC). This study will also investigate biomarkers to gain a bett...
What is the current status of trial NCT04709276?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2021-06-07. Estimated completion is 2028-08.
What conditions does trial NCT04709276 study?
This clinical trial studies the following conditions: Metastatic Prostate Cancer, Metastatic Prostate Neuroendocrine Carcinoma.
What interventions are being tested in trial NCT04709276?
The interventions under investigation include: Carboplatin (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), Cabazitaxel (DRUG).
Who is sponsoring clinical trial NCT04709276?
This trial is sponsored by Andrew J. Armstrong, MD, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04709276 being conducted?
This trial has 3 study locations across New York, North Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04709276's enrollment target sits among peer trials
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