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Monoclonal Antibodies
Domvanalimab + Zimberelimab for Liver Cancer
Phase 2
Recruiting
Led By David Hsieh, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is exploring if a drug combo can help treat advanced liver and bile duct cancers that didn't respond to other treatments. #ClinicalTrial
Who is the study for?
This trial is for adults with advanced liver or bile duct cancer that's not suitable for surgery or has come back after treatment. They must have tried anti-PD-1/L1 therapy before, be in fairly good health (ECOG score 0-1), and have a certain level of liver function (Child-Pugh Score A/B7-B8). Pregnant women, HIV-positive individuals, those with recent major surgeries or trauma, autoimmune diseases requiring treatment within the past two years, severe allergies to monoclonal antibodies, active infections like tuberculosis, and anyone on high-dose steroids can't join.
What is being tested?
The study tests if Domvanalimab combined with Zimberelimab helps treat advanced hepatobiliary cancers that haven't responded to previous treatments. Participants will receive both drugs and their effectiveness against these types of cancers will be evaluated.
What are the potential side effects?
Potential side effects may include allergic reactions to the drugs' components, immune system-related issues affecting organs due to the nature of immunotherapy agents like Domvanalimab and Zimberelimab. Specific side effects are not listed but generally could involve fatigue, nausea, skin reactions among others typical for cancer immunotherapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response rate of combination zimberelimab and domvanalimab.
Secondary study objectives
6-month progression-free survival of combination zimberelimab and domvanalimab
Disease Control Rate of combination zimberelimab and domvanalimab
Duration of response of combination zimberelimab and domvanalimab
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Zimberelimab and DomvanalimabExperimental Treatment2 Interventions
Individual will be given Zimberelimab (AB122) 360 mg IV in a 1 hour infusion + 30 minute rest + Domvanalimab (AB154) 1200 mg IV in a 1 hour infusion every three weeks. Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zimberelimab
2020
Completed Phase 2
~230
Find a Location
Who is running the clinical trial?
Cancer Prevention Research Institute of TexasOTHER
53 Previous Clinical Trials
98,986 Total Patients Enrolled
University of Texas Southwestern Medical CenterLead Sponsor
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1,056,255 Total Patients Enrolled
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Arcus Biosciences, Inc.Industry Sponsor
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Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had treatment targeting a specific area of my cancer and met all required conditions.I do not have dementia or any mental condition that affects my ability to consent.I have not had any autoimmune diseases requiring systemic treatment in the past 2 years.I have an active tuberculosis infection.My cancer can be measured by scans.I have not had major surgery or serious injury in the last 28 days.My diagnosis is liver or bile duct cancer, but not fibrolamellar HCC or combined HCC-cholangiocarcinoma.My advanced cancer cannot be treated with surgery or localized therapies, or it has worsened after such treatments.I can provide a recent biopsy or surgery sample taken within the last 3 years.I haven't taken steroids or immunosuppressants in the last 14 days.I have brain metastases but they are under control.I have had a liver transplant.I am HIV positive.My thyroid condition cannot be controlled with medication.My cancer has spread beyond its original location.I am 18 years old or older.I have not received any live vaccines in the last 28 days.My liver cancer is not caused by a virus, or it's due to hepatitis B or C.My liver function is moderately good.My organs and bone marrow are working well.I have received a COVID-19 vaccine (vector, protein subunit, or nucleic acid).I agree to use effective birth control during the study.My cancer did not respond or came back after treatment with anti-PD-1/L1 therapy.I have not had any cancer, except for treatable local cancers, in the last 2 years.I can carry out all my daily activities without help.
Research Study Groups:
This trial has the following groups:- Group 1: Zimberelimab and Domvanalimab
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.
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