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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
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
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
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 2
~2070
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.
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Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,526 Total Patients Enrolled
4 Trials studying Liver Cancer
134 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,989 Total Patients Enrolled
105 Trials studying Liver Cancer
26,544 Patients Enrolled for Liver Cancer
Vincent ChungPrincipal InvestigatorCity of Hope Medical Center
10 Previous Clinical Trials
417 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have enough neutrophils in your blood, at least 1,500 per microliter.You have had an allergic reaction to egg proteins in the past.You have an ongoing autoimmune disease or need to take corticosteroids for your condition, with exceptions for vitiligo and type I diabetes.If you have a history of heart problems, or if tests show problems with your heart, you can't participate in the study.You have a history of a weakened immune system, such as having an organ transplant or HIV.You have a certain amount of p53 protein in your tumor or a specific p53 gene mutation. If you have received p53-based vaccines before, you can still participate.You should be able to perform daily activities without needing help.Your kidneys must be working well, and your blood creatinine levels must be within a certain range.You must have a certain amount of platelets in your blood.You have received a specific type of treatment called anti-PD-1 or anti-PDL-1 before.People with certain types of cancer, such as lung, head and neck, liver, kidney, skin, bladder, breast, and colon cancer, can participate in the screening.If you have advanced solid tumors, you must have already tried and not responded well to at least one type of standard treatment, or you have chosen not to have standard treatment.Your hemoglobin level must be higher than 9 grams per deciliter.Your bilirubin levels must be within a certain range.Your AST and ALT levels in the blood must be within a certain range, unless you have evidence of liver metastasis, in which case they can be slightly higher.You are currently taking systemic corticosteroids, but nasal corticosteroids, inhaled steroids, adrenal replacement steroids, and topical steroids are allowed.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (p53MVA, pembrolizumab)
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.
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