What side effects are associated with this type of intervention?

Oncolytic virus therapy, such as VG161, can cause side effects including fever, chills, fatigue, and injection site reactions. PD-1 inhibitors like Nivolumab are associated with immune-related adverse events such as rash, pruritus, diarrhea, pneumonitis, and hepatitis. Sorafenib, a common treatment for advanced liver cancer, can cause hand-foot skin reactions, diarrhea, hypertension, and fatigue. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Nivolumab, a PD-1 inhibitor, has been approved by the FDA for the treatment of advanced hepatocellular carcinoma (HCC) following prior sorafenib treatment. This approval is based on its ability to improve overall survival and response rates in patients with advanced HCC. While VG161, an oncolytic virus therapy, is still under investigation, other immunotherapies like pembrolizumab (another PD-1 inhibitor) have also been approved for HCC treatment. These therapies represent a shift towards immunotherapy in liver cancer management, aiming to harness the body's immune system to target cancer cells.

What other types of research exist?

Promising novel alternatives for liver cancer treatment in 2024 include: 1) Atezolizumab plus Bevacizumab, which has shown significantly better overall survival compared to Sorafenib in the IMbrave150 trial for unresectable HCC. 2) Pembrolizumab, which has demonstrated efficacy in patients with advanced HCC previously treated with Sorafenib in the KEYNOTE-224 trial. 3) Tremelimumab plus Durvalumab, which is being evaluated for unresectable HCC and may offer a new combination approach targeting CTLA-4 and PD-L1.

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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

Must not have

Intercurrent serious infections within 28 days prior to Screening or treated systematically with antibiotics within 14 days prior to signing ICF

Uncontrolled congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests VG161 injections and Nivolumab IV drips in patients with liver cancers. VG161 aims to directly attack cancer cells, while Nivolumab boosts the immune system to help it fight the cancer.

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.

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.

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 below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My liver is functioning well enough for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had serious infections or taken antibiotics in the last month.

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I have heart failure that is not well-managed.

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I have not had major surgery in the last 2 weeks.

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I currently have an active Herpes infection.

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I have not taken ganciclovir or acyclovir in the last 14 days.

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I do not have a life-threatening illness unrelated to my cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

ORR

Safety in Cohort1

Secondary study objectives

Blood concentration of VG161

DOR

Immunogenicity endpoints

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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]

2019

Completed Phase 2

~160

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Oncolytic virus therapy uses genetically modified viruses to selectively infect and destroy cancer cells while also stimulating the immune system to attack the tumor. PD-1 inhibitors, like Nivolumab, block the PD-1 pathway, which cancer cells use to avoid immune detection, thereby enhancing the immune system's ability to target and destroy cancer cells. These treatments are significant for liver cancer patients as they provide targeted and potentially more effective therapeutic options, improving the chances of better outcomes.

Targets for immunotherapy of liver cancer.