What side effects are associated with this type of intervention?

Common treatments for liver cancer that involve immune checkpoint inhibitors like pembrolizumab and vaccine therapies can lead to a range of side effects. Pembrolizumab, a PD-1 inhibitor, is associated with immune-related adverse events such as fatigue, rash, diarrhea, and liver enzyme abnormalities. More severe but less common side effects include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Vaccine therapies, which aim to stimulate the immune response, can cause injection site reactions, flu-like symptoms, and other immune-related effects. Both types of treatments can lead to significant immune system activation, which may result in inflammation and autoimmunity in various organs.

What prior FDA approvals exist?

For the treatment of liver cancer, the FDA has approved several therapies that involve immune response stimulation and PD-1 inhibitors. Notably, pembrolizumab (Keytruda) has been approved for hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib. Additionally, nivolumab (Opdivo), another PD-1 inhibitor, has been approved for HCC after prior sorafenib treatment. These treatments work by enhancing the body's immune response to target and kill cancer cells, similar to the investigational combination of vaccine therapy and pembrolizumab.

What other types of research exist?

Promising novel alternatives for liver cancer treatment in 2024 include: 1) Combination of immune checkpoint inhibitors such as Atezolizumab (PD-L1 inhibitor) with Bevacizumab (anti-VEGF antibody), which has shown significant efficacy in clinical trials. 2) Tremelimumab (CTLA-4 inhibitor) combined with Durvalumab (PD-L1 inhibitor), which has demonstrated activity in advanced HCC. 3) Chimeric Antigen Receptor (CAR) T-cell therapies, which are being actively researched and have shown encouraging outcomes in early trials.

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Cancer Vaccine

Vaccine + Pembrolizumab for Cancer

Phase 1

Waitlist Available

Led By Vincent Chung

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 19

Awards & highlights

No Placebo-Only Group

Summary

This trial studies a combination of a special vaccine and pembrolizumab to treat patients with advanced solid tumors that haven't responded to other treatments. The vaccine helps the immune system recognize and attack cancer cells, while pembrolizumab boosts the immune system's ability to fight the cancer. Pembrolizumab has shown effectiveness in patients who have already received other treatments, with better outcomes and fewer side effects compared to some standard treatments.

Who is the study for?

This trial is for adults with advanced solid tumors that can't be removed by surgery or have spread and didn't respond to previous treatments. Participants must understand the study, sign consent, have certain blood counts and organ function levels, use contraception if needed, and not be pregnant. They should also not have severe allergies to egg proteins or a history of certain immune reactions.

What is being tested?

The trial tests a vaccine therapy using a modified virus expressing p53 combined with pembrolizumab (a monoclonal antibody) against various solid tumors. The goal is to see if this combination helps the immune system destroy cancer cells more effectively than current treatments.

What are the potential side effects?

Possible side effects include typical vaccine-related reactions like soreness at injection site, fever, fatigue; pembrolizumab may cause immune-related issues such as inflammation in organs like lungs or intestines, skin rashes, hormone gland problems (like thyroid), and could worsen existing autoimmune diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 19

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 19

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 19 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Clinical responses, assessed by the modified Response Evaluation Criteria in Solid Tumors (RECIST)

T cell reactivity to p53, assessed by flow cytometry

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (p53MVA, pembrolizumab)Experimental Treatment3 Interventions

Patients receive pembrolizumab IV over 30 minutes followed by modified vaccinia virus Ankara vaccine expressing p53 SC at least 30 minutes later once in weeks 1, 4, and 7. Patients may receive additional doses of pembrolizumab in weeks 10, 13, 16, and 19, for a maximum of 7 doses if there are no signs of progressive disease. Treatment continues in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

Do I qualify?Apply below to find out

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

Common treatments for liver cancer include immune checkpoint inhibitors like pembrolizumab and vaccine therapies. Pembrolizumab works by blocking the PD-1 pathway, which cancer cells exploit to avoid being attacked by the immune system. By inhibiting this pathway, pembrolizumab helps the immune system recognize and destroy cancer cells. Vaccine therapies aim to stimulate the immune system to mount a stronger response against cancer cells by introducing antigens that mimic tumor cells. These treatments are significant for liver cancer patients as they offer a targeted approach that can potentially improve outcomes and provide options beyond traditional therapies like surgery and chemotherapy.