P53MVA + Pembrolizumab for Ovarian Cancer
Trial Summary
What is the purpose of this trial?
This phase II trial studies how well modified vaccinia virus ankara vaccine expressing p53 (p53MVA) and pembrolizumab work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving p53MVA and pembrolizumab together may work better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have received any non-oncology, viral vaccines within 30 days prior to starting the trial. It's best to discuss your current medications with the trial team to get specific guidance.
What data supports the effectiveness of the treatment P53MVA + Pembrolizumab for ovarian cancer?
Research suggests that the combination of the p53MVA vaccine and pembrolizumab may enhance the immune response in patients with advanced ovarian cancer, as p53-reactive T cells were linked to clinical benefits in previous studies. However, the combination's effectiveness in providing clinical benefits requires further investigation, as initial studies showed immune activation but not immediate clinical improvement.12345
Is the combination of p53MVA vaccine and pembrolizumab safe for humans?
The combination of the p53MVA vaccine and pembrolizumab has been evaluated in patients with advanced solid tumors, including ovarian cancer, and has shown to activate immune cells without immediate clinical benefit. Safety data from these studies suggest that the treatment is generally safe, but specific side effects or adverse reactions were not detailed in the provided abstracts.12367
What makes the P53MVA + Pembrolizumab treatment unique for ovarian cancer?
This treatment combines a vaccine (p53MVA) that targets a specific protein (p53) often found in cancer cells with pembrolizumab, a drug that helps the immune system attack cancer by blocking a protein (PD-1) that prevents immune cells from killing cancer cells. This combination aims to enhance the immune response against ovarian cancer, offering a novel approach compared to traditional chemotherapy.12345
Research Team
Thanh Dellinger
Principal Investigator
City of Hope Medical Center
Eligibility Criteria
This trial is for patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer who've had platinum-based chemotherapy within the last 6 months. They must have a specific p53 gene mutation or overexpression and be in good enough health to participate (ECOG <=2). Women of childbearing potential must agree to contraception guidelines.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab IV every 3 weeks and p53MVA SC every 3 weeks for up to 3 vaccines. Pembrolizumab cycles repeat every 3 weeks for up to 49 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Modified Vaccinia Virus Ankara Vaccine Expressing p53
- Pembrolizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
City of Hope Medical Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator