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NCT04159896 · ClinicalTrials.gov registry record · Phase 2
ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer
A Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT04159896: Clinical Trial Phase 2 study, sponsored by Barbara Ann Karmanos Cancer Institute.
NCT04159896 is a Phase 2 study that was terminated before completion, run by Barbara Ann Karmanos Cancer Institute. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04159896, a Phase 2 study, was terminated before completion, sponsored by Barbara Ann Karmanos Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
This phase II trial studies the side effects of ESK981 and nivolumab and to see how well they work for the treatment of castration resistant prostate cancer that has spread to other places in the body (metastatic). ESK981 is an investigational drug that targets several important pathways that are believed to play a role in the spread of cancer. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This study is being done to see if giving ESK981 and nivolumab together works better in treating metastatic castration resistant prostate cancer compared to usual treatments.
Primary Outcome
Will assess PSA decline of \>= 50% from baseline (PSA50), using the Prostate Cancer Working Group 3 (PCWG3) criteria. Two-sided Wilson type 95% confidence interval (CI) estimates will be calculated.
Interventions
- BIOLOGICAL Nivolumab
- DRUG Pan-VEGFR/TIE2 Tyrosine Kinase Inhibitor CEP-11981
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2022-03-01 |
| Phase | Phase 2 |
Why NCT04159896 stopped before completion
NCT04159896 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT04159896 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04159896 about?
NCT04159896 is a clinical study titled "ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer". This phase II trial studies the side effects of ESK981 and nivolumab and to see how well they work for the treatment of castration resistant prostate cancer that has spread to other places in the body (metastatic). ESK981 is an investigational drug that targets several important pathways that are be...
What is the current status of trial NCT04159896?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2019-11-13. Estimated completion is 2022-03-01.
What interventions are being tested in trial NCT04159896?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Pan-VEGFR/TIE2 Tyrosine Kinase Inhibitor CEP-11981 (DRUG).
Who is sponsoring clinical trial NCT04159896?
This trial is sponsored by Barbara Ann Karmanos Cancer Institute, which has 139 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04159896's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 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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