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NCT04935229 · ClinicalTrials.gov registry record · Phase 1
Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma
A Phase 1 study, sponsored by TriSalus Life Sciences.
- Terminated
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT04935229: Clinical Trial Phase 1 study, sponsored by TriSalus Life Sciences.
NCT04935229 is a Phase 1 study that was terminated before completion, run by TriSalus Life Sciences. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04935229, a Phase 1 study, was terminated before completion, sponsored by TriSalus Life Sciences.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
This study is an open-label, phase 1/1b study of the pressure-enabled hepatic artery infusion of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in adults with metastatic uveal melanoma.
Primary Outcome
As a measure of safety, adverse events will be graded according to CTCAE v5.0.
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
- DRUG SD-101
- BIOLOGICAL Nivolumab and Relatlimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-08-02 |
| Est. Completion | 2024-07-17 |
| Phase | Phase 1 |
Why NCT04935229 stopped before completion
NCT04935229 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.
NCT04935229 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04935229 about?
NCT04935229 is a clinical study titled "Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma". This study is an open-label, phase 1/1b study of the pressure-enabled hepatic artery infusion of SD-101, a TLR 9 agonist, alone or in combination with intravenous checkpoint blockade in adults with metastatic uveal melanoma.
What is the current status of trial NCT04935229?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2021-08-02. Estimated completion is 2024-07-17.
What interventions are being tested in trial NCT04935229?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL), SD-101 (DRUG), Nivolumab and Relatlimab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04935229?
This trial is sponsored by TriSalus Life Sciences, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04935229's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 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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