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NCT03259425 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma
A Phase 2 study, sponsored by University of Utah.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT03259425: Clinical Trial Phase 2 study, sponsored by University of Utah.
NCT03259425 is a Phase 2 study that was terminated before completion, run by University of Utah. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03259425, a Phase 2 study, was terminated before completion, sponsored by University of Utah.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
This is a single-arm, open label, Phase II study evaluating the safety and efficacy of neoadjuvant Nivolumab and HF10 in resectable stage IIIB, IIIC, and IVM1a melanoma.
Primary Outcome
Following 12 weeks of neoadjuvant treatment with nivolumab and HF10, participants underwent definitive surgery. A percent viable tumor was assessed semi-quantitatively in the definitive surgical resection specimen by estimating the proportion of residual tumor in relation to the total tumor area and reported as percentage viability. A pathologic complete response was defined as no viable residual melanoma cells in the surgical specimen. A major pathologic response was defined as \<50% viable tum
Interventions
- DRUG Nivolumab
- DRUG HF10
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-01-03 |
| Est. Completion | 2020-09-25 |
| Phase | Phase 2 |
Why NCT03259425 stopped before completion
NCT03259425 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03259425 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03259425 about?
NCT03259425 is a clinical study titled "Neoadjuvant Trial of Nivolumab in Combination With HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma". This is a single-arm, open label, Phase II study evaluating the safety and efficacy of neoadjuvant Nivolumab and HF10 in resectable stage IIIB, IIIC, and IVM1a melanoma.
What is the current status of trial NCT03259425?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2018-01-03. Estimated completion is 2020-09-25.
What interventions are being tested in trial NCT03259425?
The interventions under investigation include: Nivolumab (DRUG), HF10 (DRUG).
Who is sponsoring clinical trial NCT03259425?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03259425's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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