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Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma

NCT04935229 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-10-22

No results posted yet for this 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.

Conditions

  • Metastatic Uveal Melanoma in the Liver

Interventions

DRUG

SD-101

SD-101 doses will be delivered via hepatic artery infusion using pressure enabled drug delivery using the TriNav device

BIOLOGICAL

Nivolumab

During Cohort B, nivolumab will be administered together with SD-101 and during Cohort C, it will be administered with ipilimumab and SD-101

BIOLOGICAL

Ipilimumab

During Cohort C, ipilimumab will be administered together with nivolumab and SD-101

BIOLOGICAL

Nivolumab and Relatlimab

During optional Cohort C1, nivolumab and relatlimab will be administered with SD-101

Sponsors & Collaborators

  • TriSalus Life Sciences, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-02
Primary Completion
2024-07-17
Completion
2024-07-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04935229 on ClinicalTrials.gov