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Monoclonal Antibodies
Anti-TIM-3 + Anti-PD-1 Antibodies for Liver Cancer
Phase 2
Recruiting
Led By Jared D Acoba, MD
Research Sponsored by University of Hawaii
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed hepatocellular cancer
Cirrhosis grade of Child-Pugh class A or B7
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of treatment until the date of death, assessed up to 36 months
Awards & highlights
Study Summary
This trial is studying the effectiveness of two different antibodies in treating liver cancer.
Who is the study for?
Adults with advanced liver cancer who haven't had systemic therapy can join this trial. They need good kidney function, controlled hepatitis if present, and at least one measurable tumor. They must not have severe lung conditions or be on recent immunosuppressants, live vaccines, or have other active cancers (with some exceptions). Pregnant women are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of two immune system-boosting drugs: TSR-022 (cobolimab) and TSR-042 (dostarlimab), to see if they help the body fight liver cancer better together than existing treatments.See study design
What are the potential side effects?
Possible side effects include immune-related reactions that could affect various organs, infusion-related symptoms like fever or chills, fatigue, potential blood abnormalities, and increased risk of infections due to immune system changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver cancer diagnosis was confirmed through lab tests.
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My liver disease is mild to moderate.
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My liver cancer is at an intermediate or advanced stage.
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I have HBV and am on antiviral therapy with a viral load under 100 IU/mL.
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I have a tumor that can be measured by standard criteria.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My liver tests are within the required ranges.
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I have not had any drug treatments for liver cancer.
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My kidneys work well enough, with a creatinine clearance rate of at least 40 mL/min.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of treatment until the date of death, assessed up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of treatment until the date of death, assessed up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate
Secondary outcome measures
AFP response
Duration of Response
Incidence of Treatment-Emergent Adverse Events as assessed by CTCAE v4.0
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TSR-022 (Cobolimab) and TSR-042 (Dostarlimab)Experimental Treatment1 Intervention
Patients receive TSR-022 (cobolimab, TIM-3 binding antibody) and TSR-042 (dostarlimab, PD-1 binding antibody) via IV day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Find a Location
Who is running the clinical trial?
University of HawaiiLead Sponsor
115 Previous Clinical Trials
54,647 Total Patients Enrolled
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,774 Total Patients Enrolled
Jared D Acoba, MDPrincipal InvestigatorUniversity of Hawaii
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an organ or bone marrow transplant.I have been treated with drugs targeting PD-1, PD-L1, or TIM-3.My liver cancer diagnosis was confirmed through lab tests.My liver disease is mild to moderate.I haven't had major surgery in the last 3 weeks and have recovered from any surgery effects.I have not had cancer, other than specific skin, cervical, breast, or prostate cancers, in the last 2 years.I have HBV and am on antiviral therapy with a viral load under 100 IU/mL.I have a tumor that can be measured by standard criteria.I am 18 years old or older.I am fully active or can carry out light work.My side effects from previous treatments are mild or gone.I am not pregnant and agree to avoid pregnancy during the study.I do not have any serious, uncontrolled health conditions.I do not have an active infection requiring IV antibiotics.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.My liver cancer is at an intermediate or advanced stage.My liver tests are within the required ranges.My blood clotting time is normal or near normal, even if I'm on blood thinners.I've had local treatments like surgery or ablation, but my main cancer area wasn't treated or has gotten worse.I have an autoimmune disease but haven't needed strong medication for it in the last 2 years.I have a history of specific lung conditions like asthma or pulmonary fibrosis.I haven't had recent severe heart issues like new or worsening chest pain or a heart attack in the last 6 months.I have not had any drug treatments for liver cancer.I have not received a live vaccine in the week before starting the treatment.I agree not to donate blood during the study or for 90 days after the last treatment.I do not have active or untreated brain or spinal cord cancer spread.My kidneys work well enough, with a creatinine clearance rate of at least 40 mL/min.I have been diagnosed with HIV.
Research Study Groups:
This trial has the following groups:- Group 1: TSR-022 (Cobolimab) and TSR-042 (Dostarlimab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for volunteers to join this research study?
"The information available on clinicaltrials.gov states that this trial is searching for participants at present; the initial post date was December 19th 2019 and it was most recently updated October 21st 2022."
Answered by AI
Have any previous experiments been conducted with TSR-022 and TSR-042?
"In 2010, the City of Hope conducted initial studies on TSR-022 and TSR-042. Since then, one complete trial has been concluded with 40 ongoing trials being carried out predominantly in Honolulu."
Answered by AI
To what extent could TSR-022 and TSR-042 pose a threat to patient safety?
"Due to its status as a Phase 2 trial, our team at Power judged TSR-022 and TSR-042's safety level to be a 2. This is because there are some data points regarding the drugs' general safety but no evidence yet of their efficacy."
Answered by AI
What goals are being sought through this research endeavor?
"The primary objective, as reported by GlaxoSmithKline and measured over a 36 month period from initial treatment until the best documented response is Objective Response Rate. Additionally, secondary objectives such as irRC (Objective response based on immune related Response Criteria), Progression free survival (Time from treatment to cancer progression or death) and Duration of Response (Time from tumor response to progression) will also be evaluated."
Answered by AI
How many volunteers are involved in this experiment?
"Affirmative. Clinicaltrials.gov data verifies that this investigation, initially posted on December 19th 2019, is currently enrolling individuals in the trial. 42 subjects will be recruited from two distinct medical locations."
Answered by AI
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