drugset / Trial / NCT04935229
Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-08-02
- Primary completion
- 2024-07-17
- Completion
- 2024-07-17
Outcome
Outcome not reported
Stopped (Enrollment): “The decision was made to terminate the study after the completion of Phase 1 enrollment and not proceed with Phase 2. Trial termination was not due to patient safety or data concerns.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Relatlimab | Monoclonal antibody | 160 mg | Intravenous |
| Subject | SD-101 | Oligonucleotide (other) | 0.5 mg | Other |
| Subject | SD-101 | Oligonucleotide (other) | 2 mg | Other |
| Subject | SD-101 | Oligonucleotide (other) | 4 mg | Other |
| Subject | SD-101 | Oligonucleotide (other) | 8 mg | Other |