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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 20
Awards & highlights

Summary

This trial is testing a new cancer treatment that uses a modified virus to help the body build an immunity to kill tumor cells, in combination with an antibody that targets certain cells to block tumor growth.

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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tolerability of combined modified vaccinia virus Ankara vaccine expressing p53 and pembrolizumab, using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.3
Secondary outcome measures
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
~2010

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.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
575 Previous Clinical Trials
1,922,695 Total Patients Enrolled
4 Trials studying Liver Cancer
134 Patients Enrolled for Liver Cancer
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,390 Total Patients Enrolled
105 Trials studying Liver Cancer
27,028 Patients Enrolled for Liver Cancer
Vincent ChungPrincipal InvestigatorCity of Hope Medical Center
10 Previous Clinical Trials
417 Total Patients Enrolled

Media Library

Modified Vaccinia Virus Ankara Vaccine Expressing p53 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT02432963 — Phase 1
Liver Cancer Research Study Groups: Treatment (p53MVA, pembrolizumab)
Liver Cancer Clinical Trial 2023: Modified Vaccinia Virus Ankara Vaccine Expressing p53 Highlights & Side Effects. Trial Name: NCT02432963 — Phase 1
Modified Vaccinia Virus Ankara Vaccine Expressing p53 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02432963 — Phase 1
~1 spots leftby Jul 2025