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Virus Therapy
VG161 + Nivolumab for Liver Cancer
Phase 2
Recruiting
Research Sponsored by Virogin Biotech Canada Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1
Liver function: Child-Pugh A-B for cohort 1 and 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial tests a new injection to treat liver cancer in 10 patients in Cohort 1 and up to 39-52 patients in Cohorts 2 and 3.
Who is the study for?
Adults with advanced liver cancer or bile duct cancer who've had previous treatments without success can join. They must be in good enough health to perform daily activities (ECOG 0-1) and have at least one tumor that's safe to inject with the trial drug. People with brain cancers, recent major surgeries, serious infections, HIV/syphilis, or those needing strong steroids or anticoagulants can't participate.Check my eligibility
What is being tested?
The trial is testing VG161 alone and combined with Nivolumab for liver and bile duct cancers. It has different groups: one gets a single dose of VG161; others get it plus Nivolumab. The study will stop if not enough people show improvement after initial treatment.See study design
What are the potential side effects?
Possible side effects include typical reactions at the injection site like pain or swelling, flu-like symptoms such as fever and chills, fatigue, nausea, changes in blood tests affecting liver function. Side effects from Nivolumab may include immune-related issues affecting organs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My liver is functioning well enough for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ORR
Safety in Cohort1
Secondary outcome measures
Blood concentration of VG161
DOR
Immunogenicity endpoints
+11 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Safety Run-in CohortExperimental Treatment1 Intervention
10 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days.
Group II: Cohort 4 (HCC and ICC)Experimental Treatment2 Interventions
Up to 12 patients will be treated with IT injection of VG161 ar dose level of 1.0x10E8 PFU x 3 days. and Nivolumab per approved label.
Group III: Cohort 3 (ICC)Experimental Treatment1 Intervention
20 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days.
Group IV: Cohort 2 (HCC)Experimental Treatment1 Intervention
21 patients will be treated with IT injection of VG161 in the cohort 1 at dose level of 1.0x10E8 PFU x 3 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab Injection [Opdivo]
2018
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Virogin Biotech Canada LtdLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken blood thinners or had an INR > 1.5 in the last 14 days.My tumor is not near major organs or vessels where swelling could cause harm.I haven't had serious infections or taken antibiotics in the last month.I have heart failure that is not well-managed.I haven't taken high-dose steroids or immunosuppressants in the last 2 weeks.I have a tumor that can be injected and is at least 15 mm big.My liver cancer has worsened after two types of treatment, including immunotherapy.I haven't had radiation on the tumor to be treated, or it has grown since my last radiation.I have ICC that can't be removed by surgery, it's worsened after chemotherapy, and I've had the right targeted therapy if needed.I do not have an active brain cancer or worsening brain metastases.I am 18 years old or older.I have not had major surgery in the last 2 weeks.I currently have an active Herpes infection.I have not taken ganciclovir or acyclovir in the last 14 days.I am fully active or restricted in physically strenuous activity but can do light work.My liver is functioning well enough for treatment.I do not have a life-threatening illness unrelated to my cancer.I have not taken antiviral medications in the last 14 days.I don't have active infections like HBV or HCV affecting my treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4 (HCC and ICC)
- Group 2: Cohort 2 (HCC)
- Group 3: Cohort 3 (ICC)
- Group 4: Safety Run-in Cohort
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.
What is the upper limit of subjects involved in this clinical experiment?
"Affirmative. According to the clinicaltrials.gov records, this medical experiment is actively enrolling participants since its launch on August 13th 2023 and last update on 8/8/2023. The trial searches for 97 individuals across a single facility."
Answered by AI
Are any new subjects being accepted into this research project?
"As evidenced on clinicaltrials.gov, this medical experiment is actively recruiting participants since its introduction in August 13th 2023 and most recent update 8 days later."
Answered by AI
What is the regulatory status of Cohort 4 (HCC and ICC) with regard to federal authorities?
"The safety of Cohort 4 (HCC and ICC) is rated as a 2, reflecting the fact that this Phase 2 trial has only established evidence for security but not yet efficacy."
Answered by AI
What are the fundamental aims of this experiment?
"The trial sponsor, Virogin Biotech Canada Ltd, has declared the main objective to be measured over a 12-month period is ORR. Additionally, secondary objectives such as DOR (Duration of response in all cohorts), PFS (Progression-free survival in all cohorts) and Blood concentration of VG161 (Quantity of Blood concentration of VG161 in cohort 1.) will also be monitored."
Answered by AI
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