← Back to Search

Checkpoint Inhibitor

SD-101 + Checkpoint Blockade for Metastatic Uveal Melanoma

Phase 1
Waitlist Available
Research Sponsored by TriSalus Life Sciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has measurable disease in the liver according to RECIST v.1.1 criteria
Has adequate organ function at screening as evidenced by: Platelet count >100,000/μL, Hemoglobin ≥8.0 g/dL, White blood cell count (WBC) >2,000/μL, Serum creatinine ≤2.0 mg/dL unless the measured creatinine clearance is ≥30 mL/min calculated by Cockcroft-Gault formula, Total and direct bilirubin ≤2.0 × the upper limit of normal (ULN) and alkaline phosphatase ≤5 × ULN. For patients with documented Gilbert's disease, total bilirubin up to 3.0 mg/dL is allowed, ALT and AST ≤5 × ULN, Prothrombin time/International Normalized Ratio (INR) or activated partial thromboplastin time (aPTT) test results at screening ≤1.5 × ULN (this applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 4 weeks prior to the first dose of study intervention)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment (SD-101) alone or with another cancer treatment (checkpoint blockade) in adults with a certain type of melanoma that has spread to the eye.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site, flu-like symptoms due to immune system activation by SD-101, fatigue, skin rash, digestive issues from checkpoint inhibitors like diarrhea and colitis; potential for autoimmune reactions where the body attacks its own cells; increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver cancer can be measured by standard health scans.
Select...
My blood tests show my organs are working well.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer, mainly in the liver, has been confirmed by lab tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Phase 1: To Determine the Safety of SD-101 Alone, in Combination with Nivolumab, and in Combination with Both Nivolumab and Ipilimumab
Phase 1b: To Assess Overall Response Rate (ORR)
+1 more
Secondary outcome measures
Phase 1: Determination of Single vs. Dual-agent CPI in Phase 1b using CTCAE v5.0
Phase 1: Determination of Single vs. Dual-agent CPI in Phase 1b using RECIST v1.1
Phase 1b: Assess Preliminary Efficacy in Terms of RECIST v1.1 for Immune Based Therapeutics
+3 more

Side effects data

From 2017 Phase 1 & 2 trial • 9 Patients • NCT02254772
100%
Arthralgia
100%
Myalgia
100%
Headache
100%
Fatigue
56%
Fever
56%
Injection site reaction
44%
Chills
33%
Rash
33%
Bruising
33%
Nasal Congestion
33%
Cough
33%
Swelling
22%
Induration
22%
Bloating
11%
Neutropenia
11%
Diarrhea
11%
Back pain
11%
Anorexia
11%
Dysphagia
11%
Anemia
11%
Nausea
11%
Flu Like Symptoms
11%
Pancytopenia
11%
Sepsis
11%
Malaise
11%
Increased Creatinine
11%
Dyspnea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (SD-101 + Ipilimumab + Radiation)

Trial Design

1Treatment groups
Experimental Treatment
Group I: SD-101Experimental Treatment4 Interventions
3 weekly doses of SD-101 given via hepatic artery infusion over 2 cycles
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SD-101
2014
Completed Phase 2
~90
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2620

Find a Location

Who is running the clinical trial?

TriSalus Life Sciences, Inc.Lead Sponsor
4 Previous Clinical Trials
192 Total Patients Enrolled

Media Library

Uveal Melanoma Research Study Groups: SD-101
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04935229 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the most important outcomes of this investigation?

"This clinical trial has a 12-month primary assessment measure of Overall Survival (OS). Additionally, secondary outcomes will be measured with the CTCAE v5.0 and RECIST v1.1 systems to assess Treatment-Emergent Adverse Events and response rates from Cohorts B & C in Phase 1 respectively."

Answered by AI

How many participants are being admitted to this clinical research?

"Affirmative. Records on clinicaltrials.gov affirm that this medical research, which was initially posted in August 2021, is actively admitting volunteers. Approximately 80 participants need to be recruited from 9 different healthcare facilities."

Answered by AI

Has the FDA sanctioned SD-101 for public consumption?

"Given the experimental nature of SD-101, our team at Power has awarded it a safety score of 1. This is because Phase 1 trials have limited data surrounding efficacy and safety."

Answered by AI

Are there numerous sites running this trial in the state?

"This study is being hosted at UCLA in Los Angeles, University of Colorado in Denver, and Washington University in Seattle; as well as 6 other sites."

Answered by AI

Have any past investigations been conducted involving SD-101?

"Initial research into SD-101 began in 2009 at Texas Children's Hospital. Since then, 368 studies have been completed while 764 are presently ongoing, many of which occur within the cities of Los Angeles and Colorado."

Answered by AI

What medicinal benefits has SD-101 been observed to provide?

"SD-101 is chiefly utilized in the treatment of anti-angiogenic therapy, but also has a variety of other applications such as melanoma, neoplasms and squamous cell carcinoma."

Answered by AI

Are volunteers being accepted for this scientific experiment at present?

"Affirmative. The clinicaltrials.gov website indicates that this research endeavour, originally posted on August 2nd 2021, is currently welcoming patients. 80 individuals need to be recruited across 9 different medical facilities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma
2021. "Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04935229.
~9 spots leftby Sep 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top