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

Part of paid clinical trials in Los Angeles, California.

Sponsor
TriSalus Life Sciences, Inc.
Study ID
NCT04935229
Phase
PHASE1
Status
Terminated

Conditions

  • Metastatic Uveal Melanoma in the Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SD-101 — DRUG
    SD-101 doses will be delivered via hepatic artery infusion using pressure enabled drug delivery using the TriNav device
  • Nivolumab — BIOLOGICAL
    During Cohort B, nivolumab will be administered together with SD-101 and during Cohort C, it will be administered with ipilimumab and SD-101
  • Ipilimumab — BIOLOGICAL
    During Cohort C, ipilimumab will be administered together with nivolumab and SD-101
  • Nivolumab and Relatlimab — BIOLOGICAL
    During optional Cohort C1, nivolumab and relatlimab will be administered with SD-101

Study Details

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.

Key Dates

Start date
Aug 2, 2021
Status verified
Oct 2025
Primary completion
Jul 17, 2024
Completion
Jul 17, 2024

Study Design

Enrollment
67 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: SD-101
    3 weekly doses of SD-101 given via hepatic artery infusion over 2 cycles

Primary Outcome Measure

Phase 1: To Determine the Safety of SD-101 Alone, in Combination with Nivolumab, and in Combination with Both Nivolumab and Ipilimumab [ Time Frame: 12 months ]

Locations (10)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095-
StanfordStanfordCalifornia94305-
University of ColoradoDenverColorado80045-
University of MiamiMiamiFlorida33136-
Massachusetts General HospitalBostonMassachusetts02114-
Columbia University Medical CenterNew YorkNew York10032-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-
MD Anderson Cancer CenterHoustonTexas77030-
Washington UniversitySeattleWashington98109-

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CAStanford· Stanford, CAUniversity of Colorado· Denver, COUniversity of Miami· Miami, FLMassachusetts General Hospital· Boston, MAColumbia University Medical Center· New York, NY

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