Study of VG161 for Liver and Bile Duct Cancers

This study is testing a new treatment called VG161, alone or with Nivolumab (Opdivo), for people with hepatocellular carcinoma (a type of liver cancer) or intrahepatic cholangiocarcinoma (a type of bile duct cancer). VG161 is an oncolytic virus, meaning it's designed to infect and kill cancer cells. Researchers want to see how safe and effective these treatments are. You might be able to join if you are 18 or older and have advanced liver or bile duct cancer that has progressed after other treatments. The study will look at how many people respond to the treatment and how long they live without their cancer getting worse. The current recruitment status is unclear.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It plans to enroll about 97 participants in different groups, some receiving VG161 alone and others receiving VG161 with Nivolumab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track your safety for 12 months and your response to treatment for 12 months. It will also measure how long you live without your cancer getting worse for 3 months.

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

NCT05223816

An Open-Label, Multiple-Center, Phase IIa/IIb Clinical Trial to Evaluate the Efficacy, Safety and Tolerability of VG161 as Monotherapy and in Combination With Nivolumab for Treatment of Patients With Hepatocellular Carcinoma or Intrahepatic Cholangiocarcinoma

UNKNOWN
PHASE2Ages 18+InterventionalTreatment
Virogin Biotech Canada Ltd
~97 participants
Updated 2024-08-09 on ClinicalTrials.gov
What's tested:VG161Nivolumab Injection [Opdivo]

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety in Cohort1
Measured over 12 months
+2 more outcomes measured
Hepatocellular Carcinoma
Intrahepatic Cholangiocarcinoma

NCT05223816

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Mayo Clinic

    Phoenix, Arizonano site contact published

    Recruiting

  • Mayo Clinic

    Rochester, Minnesotano site contact published

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Floridano site contact published

    Recruiting

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

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  • Safety in Cohort112 months

    Occurrence and severity of AEs, SAEs (according to NCI CTCAE version 5.0) in Safety Run-in Cohort (cohort 1)

  • ORR12 months

    Objective response rate in HCC Cohort (Cohort 2) and ICC Cohort (Cohort 3)

  • PFS3 months

    Progression-free survival in HCC Cohort (Cohort 2)