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NCT04477512 · ClinicalTrials.gov registry record · Phase 1
Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)
A Phase 1 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT04477512: Completed Phase 1 study, sponsored by Washington University School of Medicine.
NCT04477512 is a Phase 1 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 18 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04477512, a Phase 1 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
The goal of this study is to determine the recommended phase 2 dose of the multi-drug combination of abiraterone, cabozantinib, and nivolumab in conjunction with ongoing androgen deprivation therapy in previously untreated metastatic hormone-sensitive prostate cancer patients. The investigators hypothesize that the combination of cabozantinib and abiraterone acetate/prednisone in conjunction with nivolumab will have an acceptable safety profile and will be feasible to administer in patients with hormone-sensitive metastatic prostate cancer.
Primary Outcome
* Protocol defined hematologic DLTs that occur during the first cycle that are attributed as possibly, probably, or definitely related to study treatment * Protocol defined non-hematologic DLTs possibly, probably, or definitely related grade 3 or 4 non-hematologic toxicity that occurs during the first cycle of treatment.
Interventions
- DRUG Nivolumab
- DRUG Prednisone
- DRUG Cabozantinib
- DRUG Abiraterone acetate
- PROCEDURE Peripheral blood collection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-02-19 |
| Est. Completion | 2025-09-10 |
| Phase | Phase 1 |
What the finished NCT04477512 record still lists
NCT04477512 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 5 interventions - of which Nivolumab is the first listed.
NCT04477512 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04477512 about?
NCT04477512 is a clinical study titled "Cabozantinib and Abiraterone With Checkpoint Inhibitor Immunotherapy in Metastatic Hormone Sensitive Prostate Cancer (CABIOS Trial)". The goal of this study is to determine the recommended phase 2 dose of the multi-drug combination of abiraterone, cabozantinib, and nivolumab in conjunction with ongoing androgen deprivation therapy in previously untreated metastatic hormone-sensitive prostate cancer patients. The investigators hypo...
What is the current status of trial NCT04477512?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-02-19. Estimated completion is 2025-09-10.
What interventions are being tested in trial NCT04477512?
The interventions under investigation include: Nivolumab (DRUG), Prednisone (DRUG), Cabozantinib (DRUG), Abiraterone acetate (DRUG), Peripheral blood collection (PROCEDURE).
Who is sponsoring clinical trial NCT04477512?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04477512's enrollment target sits among peer trials
18 1720th of 2000 higher than 216 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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