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Study of New Immunotherapies for Advanced Liver and Bile Duct Cancers

This study is looking at new treatments for advanced liver cancer (Hepatocellular Carcinoma) and bile duct cancer (Biliary Tract Cancer). Researchers are testing drugs called Volrustomig and Rilvegostomig, both alone and in combination with other cancer medicines like Bevacizumab, Lenvatinib, Gemcitabine, and Cisplatin. You might be able to join if you are 18 or older, have advanced solid tumors as specified in the study, and have good overall health. The study aims to see how well these treatments shrink tumors (Objective Response Rate), how long you live without the cancer growing (Progression Free Survival), and what side effects occur over about two years. The study plans to enroll 294 participants, but its current status is unclear.

Study design
This is an open-label (meaning you and your doctors will know what treatment you are receiving), uncontrolled study across multiple centers. It has a modular design with independent substudies, planning to enroll 294 participants.
What's involved
You would receive treatments like Volrustomig, Rilvegostomig, Bevacizumab, Lenvatinib, Gemcitabine, and/or Cisplatin. Treatments like Bevacizumab and Lenvatinib would continue until your disease progresses or side effects become too severe.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be measured through study completion, which is an average of two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05775159

Study of Novel Immunomodulators as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Hepatobiliary Cancer

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
AstraZeneca
~294 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:VolrustomigBevacizumabLenvatinibRilvegostomigGemcitabineCisplatin

At a glance

Recruiting sites
0 of 46 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate (ORR)
Measured over Through study completion, an average of 2 years
+2 more outcomes measured

Conditions

Hepatocellular Carcinoma
Biliary Tract Cancer

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Hepatocellular CarcinomaMalignant neoplasm of biliary tract

NCT05775159

Where you'd take part

This study runs at 46 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Birmingham, Alabamano site contact published

  • Research Site

    Los Angeles, Californiano site contact published

  • Research Site

    Orange, Californiano site contact published

  • Research Site

    Kansas City, Kansasno site contact published

  • Research Site

    New York, New Yorkno site contact published

  • Research Site

    Beijing, Chinano site contact published

  • Research Site

    Beijing, Chinano site contact published

  • Research Site

    Beijing, Chinano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Age ≥18 years at the time of signing the ICF.
Provision of a signed and dated written ICF.
Confirmed locally advanced or metastatic solid tumor specified in substudy based on histopathology.
Adequate organ and bone marrow function.
At least 1 measurable not previously irradiated lesion per RECIST 1.1
Life expectancy of at least 12 weeks at the time of screening.
Willing and able to provide an adequate tumor sample.

Exclusion

History of allogeneic organ transplantation.
Active or prior documented autoimmune or inflammatory disorders.
Uncontrolled intercurrent illness.
History of another primary malignancy, leptomeningeal carcinomatosis, and active primary immunodeficiency.
Active infection, brain metastases or spinal cord compression.
Participants co-infected with HBV and hepatitis D virus (HDV).
Previous treatment in the present study.
For substudy 1, history of hepatic encephalopathy within 12 months prior to treatment allocation.

What this trial measures

  • Objective response rate (ORR)Through study completion, an average of 2 years

    ORR is defined as the proportion of participants who have a confirmed CR (complete response) or confirmed PR (partial response), determined by the Investigator at local site per RECIST 1.1 (For HCC sub-study 1)

  • The number of participants with adverse events/serious adverse eventsThrough study completion, an average of 2 years

    Number of participants with adverse events and with serious adverse events including abnormal clinical observations, abnormal Electrocardiogram (ECG) parameters, abnormal laboratory assessments and abnormal vital signs that changed from baseline.

  • Progression free survival (PFS)Through study completion, an average of 2 years

    PFS is defined as the time from the start of studyintervention until progression per RECIST 1.1 as assessed by the Investigator at the local site or death due to any cause in the absence of progression, whichever occurs first. (For BTC sub-study 2)