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Checkpoint Inhibitor

SD-101 + Checkpoint Inhibitors for Liver Cancer

Phase 1 & 2

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

Nonsterilized males must agree to contraception measures

Must have previously received 1 line of standard therapy for liver cancer and have persistent or progressive measurable disease not amenable to curative therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment that uses a TLR9 agonist to treat HCC and ICC.

Who is the study for?

Adults over 18 with advanced liver or bile duct cancer that's not removable by surgery, who've had one standard treatment but still have growing tumors. They need good blood counts, kidney and liver function, and can't be pregnant or breastfeeding. People with severe allergies to trial drugs or certain medical conditions like active infections are excluded.Check my eligibility

What is being tested?

This study tests SD-101 delivered directly into the liver artery using pressure technology alone or combined with immune checkpoint blockers (Nivolumab, Ipilimumab, Pembrolizumab) given through IV. It aims to see how well these treatments work for patients with specific types of liver cancers.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, flu-like symptoms from SD-101; fatigue, skin issues, hormonal changes from Nivolumab and Pembrolizumab; and potentially more serious immune-related effects from Ipilimumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man who can father children and agree to use birth control.

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I have liver cancer, have tried one standard treatment, and my cancer is still growing or present.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I am 18 or older with advanced liver cancer or bile duct cancer.

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My liver function is classified between Child-Pugh A to B7.

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I haven't had chemotherapy, targeted therapy, or radiation in the last 14 days.

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I have never had embolic HAI therapy with permanent materials.

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My liver cancer can be measured by standard health guidelines.

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My liver cancer is confirmed by tests and mainly affects my liver.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

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

Phase 2: To Assess Overall Response Rate (ORR)

Secondary outcome measures

Phase 1b: Assess Preliminary Efficacy in Terms of RECIST v1.1 for Immune Based Therapeutics

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

Phase 1b: Assess Preliminary Efficacy in Terms of modified RECIST (mRECIST) 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%

Study treatment Arm

Treatment (SD-101 + Ipilimumab + Radiation)

Trial Design

1Treatment groups

Experimental Treatment

Group I: SD-101Experimental Treatment4 Interventions

Three weekly doses of SD-101 given over two cycles via HAI using the PEDD method of administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SD-101

2014

Completed Phase 2

~90

Nivolumab

FDA approved

Ipilimumab

FDA approved

Pembrolizumab

FDA approved

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

TriSalus Life Sciences, Inc.Lead Sponsor

4 Previous Clinical Trials

183 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05220722 — Phase 1 & 2

Liver Cancer Research Study Groups: SD-101

Liver Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT05220722 — Phase 1 & 2

Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05220722 — Phase 1 & 2

Frequently Asked Questions

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

Is there an opportunity for me to participate in this medical experiment?

"This clinical study is looking for 89 individuals in the 18-99 age range suffering from intrahepatic cholangiocarcinoma. In order to qualify, potential participants must exhibit adequate hematological and organ function, as well as having never received prior embolic HAI therapy with permanent material; they will also need to demonstrate locally advanced metastatic or unresectable hepatocellular carcinoma/intrahepatic cholangiocarcinoma, have previously received one line of standard therapy for liver cancer and still possess persistent or progressive measurable disease (as defined by RECIST v1.1),"

Answered by AI

Are there spots still available for prospective participants in this experiment?

"Reports on clinicaltrials.gov confirm that this medical trial is recruiting participants at the moment. It was first made public on March 2nd, 2022 and its latest update occurred 19 October of the same year."

Answered by AI

Is the age of consent for this trial set at 18 or younger?

"The protocol of this clinical trial requires that participants must be between 18 and 99 years old. For those below the legal age, there are 85 studies available while 2734 trials cater to people over 65."

Answered by AI

What aims is this trial attempting to accomplish?

"The primary aim of this trial, over a period of roughly 12 months, is to ascertain the Maximum Tolerable Dose (MTD) or Optimal Dose of SD-101 in isolation and combination with pembrolizumab, nivolumab and ipilimumab. Secondary outcomes that will be evaluated include assessing efficacy through RECIST v1.1 for immune based therapeutics, determining overall survival rate using death events as an indicator, and gauging preliminary efficacy utilizing modified RECIST (mRECIST)."

Answered by AI

What is the current enrollment size of this trial?

"TriSalus Life Sciences, Inc. has the objective of recruiting 89 eligible patients for their clinical trial. This study will be conducted in multiple sites including Columbia University (Providence, Rhode island) and Rhode Island Hospital (Houston, Texas)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors

2022. "Pressure Enabled Delivery of SD-101 With Checkpoint Blockade for Primary Liver Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05220722.

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