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NCT03554317 · ClinicalTrials.gov registry record · Phase 2
COMbination of Bipolar Androgen Therapy and Nivolumab
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
NCT03554317 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 45 participants.
The verdict
NCT03554317, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
Study Summary
Single arm, multicenter, open-label Phase II study of the effects of parenteral testosterone in combination with nivolumab in men with metastatic castration-resistant prostate cancer who previously progressed on at least one novel androgen-receptor targeted therapy (i.e. Abiraterone acetate, Enzalutamide). Up to one taxane agent is permitted.
Interventions
- DRUG Nivolumab
- DRUG Testosterone cypionate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-09-05 |
| Est. Completion | 2023-01-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03554317
The ClinicalTrials.gov registry entry for NCT03554317 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03554317 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03554317 about?
NCT03554317 is a clinical study titled "COMbination of Bipolar Androgen Therapy and Nivolumab". Single arm, multicenter, open-label Phase II study of the effects of parenteral testosterone in combination with nivolumab in men with metastatic castration-resistant prostate cancer who previously progressed on at least one novel androgen-receptor targeted therapy (i.e. Abiraterone acetate, Enzalut...
What is the current status of trial NCT03554317?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2018-09-05. Estimated completion is 2023-01-06.
What interventions are being tested in trial NCT03554317?
The interventions under investigation include: Nivolumab (DRUG), Testosterone cypionate (DRUG).
Who is sponsoring clinical trial NCT03554317?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
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