Domvanalimab and Zimberelimab in Advanced Liver Cancers (NCT05724563) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Domvanalimab and Zimberelimab in Advanced Liver Cancers
United States58 participantsStarted 2023-06-01
Plain-language summary
The goal of this clinical trial is to learn about advanced liver and bile duct cancers. The main question it aims to answer is:
If the combination of Domvanalimab and Zimberelimab are effective in treating advanced hepatobiliary cancers that have failed prior treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient must have a histologically confirmed diagnosis consistent with HCC or bile duct cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gall bladder cancers); known fibrolamellar HCC, or combined HCC-cholangiocarcinoma will be excluded.
. Locally advanced or metastatic disease
. Refractory to or relapsed after prior anti-PD-1/L1 antibody therapy. May have received anti-PD-1/L1 monotherapy or combination therapy as any line of therapy including in the neoadjuvant or adjuvant setting. Patients who discontinued prior immune checkpoint inhibitor treatment due to toxicity are not eligible.
. Availability of recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block or slides in which the biopsy or resection was performed within 3 years. Baseline tissue can be obtained after consent but must be prior to initiation of zimberelimab and domvanalimab. It is strongly recommended that tissue is obtained from biopsies confirming progression of disease on prior therapy so that the patient has not received any intervening systemic anti-cancer treatment from the time that the baseline tissue was obtained.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 2 and is testing the combination of domvanalimab and zimberelimab — which are both immunotherapy drugs — so how much do we actually know so far about whether this combination is safe and effective for liver or bile duct cancers like mine?
2The trial is listed as 'active, not recruiting,' which means they're no longer accepting new patients — does that close the door completely, or is there any pathway for me to access either of these drugs through a compassionate use program or another study?
3The main thing this trial is measuring is 'objective response rate,' meaning how many patients' tumors actually shrink — based on what you know about immunotherapy in hepatocellular carcinoma or cholangiocarcinoma, how realistic is a meaningful response for someone in my situation?
4Before considering a trial like this, should I first try an established standard-of-care treatment for my specific cancer type, and would doing so affect my eligibility for similar studies in the future?
5Since this combines two immunotherapy agents targeting different pathways, are there specific side effects or risks I should be asking about that might be different from what I'd expect with a single immunotherapy drug?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response rate of combination zimberelimab and domvanalimab.
Timeframe: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months
Trial details
NCT IDNCT05724563
SponsorUniversity of Texas Southwestern Medical Center
. Prior locoregional is allowed provided the following are met: 1) at least 2 weeks since prior locoregional therapy including surgical resection, chemoembolization, radiotherapy, or ablation; 2) target lesion has increased in size ≥25% or the target lesion was not treated with locoregional therapy. Patients treated with palliative radiotherapy for symptoms will be eligible as long as the target lesion is not the treated lesion and radiotherapy will be completed at least 2 weeks prior to study drug administration.
. Age ≥ 18 years
. Child-Pugh Score A or B7-8 (only for Cohort A)
. ECOG Performance score of 0-1
Exclusion criteria
. Prior liver transplant.
. Known human immunodeficiency virus (HIV) positive (testing not required).
. Use of any live vaccines against infectious diseases within 28 days of first dose of study drug administration.
. History of trauma or major surgery within 28 days prior to the first dose of study drug administration. (Tumor biopsy or placement of central venous access catheter (eg, port or similar) is not considered a major surgical procedure).
. Underlying medical conditions that, in the investigator's opinion, will make the administration of study drugs hazardous, including but not limited to:
. Hypersensitivity to IV contrast; not suitable for pre-medication.
. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication.
. Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.