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NCT03543189 · ClinicalTrials.gov registry record · Phase 1
Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy
A Phase 1 study of Prostate Cancer and Prostate Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT03543189: Active Phase 1 study of Prostate Cancer and Prostate Disease, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03543189 is a Phase 1 study of Prostate Cancer and Prostate Disease that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 44 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03543189, a Phase 1 study of Prostate Cancer and Prostate Disease, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test the safety, tolerability, and effectiveness of the investigational drug nivolumab (Opdivo™) in combination with high dose radiation. Investigators also want to see if these study drugs help to delay the progression of prostate cancer.
Primary Outcome
An initial set of 6 participants will be enrolled at Dose Level 1. If 0 or 1 dose limiting toxicity (DLT) is observed during Cycle 1, enrollment in the phase II at Dose Level 1 will be initiated. If DLT is observed in 2 patients during Cycle 1, an additional 3 participants will be enrolled at Dose Level 1 (total 9 patients). If DLT is observed in ≤ 2 of 9 patients, enrollment in the phase II as Dose Level 1 will be initiated. If DLT is observed in 3 or more of 9 patients at Dose Level 1, the max
Conditions Studied
Interventions
- RADIATION External Beam Radiation Therapy
- RADIATION Brachytherapy
- DRUG Nivolumab
- DRUG Androgen Deprivation Therapy
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2018-10-03 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT03543189 still lists
NCT03543189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 4 interventions - of which External Beam Radiation Therapy is the first listed.
NCT03543189 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03543189 about?
NCT03543189 is a clinical study titled "Combination of Nivolumab Immunotherapy With Radiation Therapy and Androgen Deprivation Therapy". The purpose of this study is to test the safety, tolerability, and effectiveness of the investigational drug nivolumab (Opdivo™) in combination with high dose radiation. Investigators also want to see if these study drugs help to delay the progression of prostate cancer.
What is the current status of trial NCT03543189?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2018-10-03. Estimated completion is 2026-12.
What conditions does trial NCT03543189 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Disease.
What interventions are being tested in trial NCT03543189?
The interventions under investigation include: External Beam Radiation Therapy (RADIATION), Brachytherapy (RADIATION), Nivolumab (DRUG), Androgen Deprivation Therapy (DRUG).
Who is sponsoring clinical trial NCT03543189?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03543189 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03543189's enrollment target sits among peer trials
44 514th of 735 higher than 221 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer 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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