SD-101 + Checkpoint Blockade for Metastatic Uveal Melanoma

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: TriSalus Life Sciences, Inc.

Must not be taking: Chemotherapy, Immunosuppressants

Disqualifiers: Brain metastasis, Hepatitis, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 9

80 Participants Needed

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.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Sentinel Cohort

Patients receive 2 SD-101 infusions (2 weeks apart) with assessments for toxicity

4 weeks

2 visits (in-person)

Cohorts A-C and Phase 1b

Patients receive 2 cycles of SD-101 with escalating doses, alone or in combination with checkpoint inhibitors

6 weeks

6 visits (in-person)

Optional Cohort D

Exploration of combination CPI regimens with modified SD-101 dosing schedule

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Treatment Details

Interventions

• Ipilimumab
• Nivolumab
• SD-101

Trial Overview The 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

Group I: SD-101 Experimental Treatment 4 Interventions

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

Ipilimumab is already approved in United States, European Union for the following indications:

Approved in United States as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Approved in European Union as Yervoy for:

• Advanced melanoma
• Stage III unresectable melanoma
• Stage IV metastatic melanoma

Who Is Running the Clinical Trial?

TriSalus Life Sciences, Inc.

Lead Sponsor

Trials

10

Recruited

420+