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

NCT04935229 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: TS-PERIO-01
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Uveal Melanoma; Liver Metastases; TLR9; SD-101

Outcome Measures

Primary Outcomes (4)

• Phase 1: To Determine the Safety of SD-101 Alone, in Combination with Nivolumab, and in Combination with Both Nivolumab and Ipilimumab

  As a measure of safety, adverse events will be graded according to CTCAE v5.0.

  12 months

• Phase 1: To Determine the Maximum Tolerable Dose (MTD) or Optimal Dose of SD-101 alone, in Combination with Nivolumab, and in Combination with Both Nivolumab and Ipilimumab

  A standard 3+3 dose-escalation design will be employed to determine the MTD or optimal dose.

  12 months

• Phase 1b: To Assess Overall Response Rate (ORR)

  As a measure of activity, ORR will be assessed. ORR will be assessed using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

  12 months

• Phase 1b: To Assess Overall Survival (OS)

  As a measure of activity, OS will be assessed. The events for the assessment of 12-month OS are death events.

  12 months

Secondary Outcomes (9)

• Phase 1: Determination of Single vs. Dual-agent CPI in Phase 1b using CTCAE v5.0

  6 months

• Phase 1: Determination of Single vs. Dual-agent CPI in Phase 1b using RECIST v1.1

  6 months

• Phase 1b: To Assess Treatment-Emergent Adverse Events of the Chosen MTD or Optimal Dose of SD-101 in Combination with CPI

  6 months

• Phase 1b: Assess Preliminary Efficacy in Terms of iRECIST for Immune Based Therapeutics

  12 months

• Phase 1b: Assess Preliminary Efficacy in Terms of modified RECIST (mRECIST) for Immune Based Therapeutics

  12 months

Study Arms (1)

SD-101

EXPERIMENTAL

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

Drug: SD-101; Biological: Nivolumab; Biological: Ipilimumab; Biological: Nivolumab and Relatlimab

Interventions

SD-101 DRUG

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

SD-101

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

Also known as: Opdivo

SD-101

Ipilimumab BIOLOGICAL

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

Also known as: Yervoy

SD-101

Nivolumab and Relatlimab BIOLOGICAL

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

Also known as: Opdualag

SD-101

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age ≥18 years of age at screening
• Able to understand the study and provide written informed consent prior to any study procedures
• Has histologically or cytologically confirmed metastatic UM with liver-only or liver dominant disease. Liver-dominant disease will be defined as intrahepatic metastases representing the largest fraction of disease relative to other organs.
• Has not received prior cytotoxic chemotherapy, targeted therapy, or external radiation therapy within 14 days prior to screening
• Has not received therapy with prior immunological checkpoint blockade within 21 days before the first dose of study intervention and has no ongoing immune-mediated AEs Grade 2 or higher
• Prior surgical resection or radiofrequency ablation of oligometastatic liver disease is allowed on both the Phase 1 and Phase 1b portions of this study. Liver lesions that received ablative therapies should not be considered target lesions unless they have clearly progressed since the therapy.
• Has no prior history of or other concurrent malignancy unless the malignancy is clinically insignificant, no ongoing treatment is required, and the patient is clinically stable
• Has measurable disease in the liver according to RECIST v.1.1 criteria
• Has an ECOG PS of 0-1 at screening
• Has a life expectancy of \>3 months at screening as estimated by the investigator
• Has a QTc interval ≤480 msec
• All associated clinically significant (in the judgment of the investigator) drug-related toxicity from previous cancer therapy must be resolved (to Grade ≤1 or the patient's pretreatment level) prior to study treatment administration (Grade 2 alopecia and endocrinopathies controlled on replacement therapy are allowed)
• Has adequate organ function at screening as evidenced by:
• Platelet count \>100,000/μL
• Hemoglobin ≥8.0 g/dL

You may not qualify if:

• Has received chemotherapy or an investigational agent within 14 days (or 5 half-lives, whichever is shorter) before screening
• Has active, untreated brain metastasis
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Has portal vein thrombosis, or severe portal hypertension as defined by a history of variceal hemorrhage or active ascites accumulation
• Has more than 2/3 parenchymal replacement by tumor of both liver lobes
• Phase 1 and Phase 1b:
• Has Child-Pugh Class B or C cirrhosis, or
• Has experienced a Grade 3 or higher immune-related AE from prior CPI therapy that has not recovered to Grade 1 for a minimum of 14 days prior to administration of SD-101 or CPI, or
• Is unable to be temporarily removed from chronic anticoagulation therapy, or
• Has a history of bleeding disorders
• Has active coronavirus disease 2019 (COVID-19), other severe infection, including a liver infection, within 2 weeks before the first dose of study drug, or uncontrolled human immunodeficiency virus (HIV) infection at screening
• Has had bacterial pneumonia within 8 weeks of first dose of study drug
• Is receiving systemic steroid therapy \>10 mg of prednisone daily or equivalent or any other immunosuppressive medication at any dose level. Local steroid therapies (e.g., otic, ophthalmic, intra-articular or inhaled medications) are acceptable.
• Has significant concurrent or intercurrent illness, psychiatric disorder, or alcohol or chemical dependence that would, in the opinion of the Investigator and/or Medical Monitor, compromise their safety or compliance or interfere with interpretation of the study
• Lactating women are excluded from study participation

Sponsors & Collaborators

• TriSalus Life Sciences, Inc.: lead

Study Sites (10)

UCLA

Los Angeles, California, 90095, United States

Location

Stanford

Stanford, California, 94305, United States

Location

University of Colorado

Denver, Colorado, 80045, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Washington University

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Nivolumab; Ipilimumab; relatlimab; Opdualag

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sentinel Cohort: Two doses of SD-101 (0.5mg and 2mg) administered 2 weeks apart via PEDD/HAI using the TriNav device. Cohorts A, B, C, and Phase 1b: Three weekly doses of SD-101 (given over two 52-day cycles) in dose-escalation fashion (2mg, 4mg, 8mg-optional) via PEDD/HAI using the TriNav device. Cohort D (optional): Two weekly doses of SD-101 (given over two 52-day cycles) via PEDD/HAI using the TriNav device.

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 22, 2021
• Study Start: August 2, 2021
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (10)