SD-101 + Checkpoint Blockade for Metastatic Uveal Melanoma

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: TriSalus Life Sciences, Inc.

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for adults with eye cancer that has spread. The treatment uses a special drug to boost the immune system, either alone or with other immune-boosting drugs. It aims to help the body better fight the cancer.

Research Team

Eligibility Criteria

Adults over 18 with metastatic uveal melanoma, who haven't had certain recent treatments or severe side effects from past immunotherapies. They should be in relatively good health (ECOG PS of 0-1), have a life expectancy over 3 months, and not be pregnant or breastfeeding. Participants must agree to use effective contraception and have adequate organ function. Those with significant liver disease, active infections like COVID-19, other serious illnesses, or known allergies to trial drugs are excluded.

Inclusion Criteria

Able to understand the study and provide written informed consent prior to any study procedures

My liver cancer can be measured by standard health scans.

My blood tests show my organs are working well.

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Exclusion Criteria

I have an active hepatitis B or C infection.

I have previously been treated with SD-101.

I have severe liver disease, had a serious reaction to immunotherapy, can't stop blood thinners, or have a bleeding disorder.

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Treatment Details

Interventions

Ipilimumab (Checkpoint Inhibitor)
Nivolumab (Checkpoint Inhibitor)
SD-101 (TLR 9 Agonist)

Trial OverviewThe trial is testing SD-101 delivered directly into the liver using pressure (PERIO) alone or combined with intravenous checkpoint inhibitors Nivolumab and Ipilimumab or Nivolumab plus Relatlimab. It's an early-phase study to see how safe this approach is for treating liver-dominant metastatic uveal melanoma.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: SD-101Experimental Treatment4 Interventions

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