P53MVA + Pembrolizumab for Ovarian Cancer

Recruiting in Palo Alto (17 mi)

Overseen byMihaela C Cristea

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

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.

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

I can care for myself and doctors expect me to live at least 3 more months.

I have had up to 4 chemotherapy treatments for my recurring cancer.

Meet specific laboratory criteria including ANC, platelets, hemoglobin, creatinine, bilirubin, AST, ALT, INR, aPTT, LVEF

+5 more

Exclusion Criteria

I haven't had cancer treatment in the last 4 weeks.

I am currently being treated for an infection.

My family has a history of Li-Fraumeni syndrome.

+17 more

Participant Groups

The study tests a combination of a modified vaccinia virus ankara vaccine expressing p53 (p53MVA) and pembrolizumab, an immunotherapy drug. The goal is to see if this combo can stimulate the immune system to fight cancer cells more effectively than current treatments.

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab, p53MVA)Experimental Treatment2 Interventions

Patients receive pembrolizumab IV over 30 minutes every 3 weeks and modified vaccinia virus ankara vaccine expressing p53 SC every 3 weeks for up to 3 vaccines. Cycles with pembrolizumab repeat every 3 weeks for up to 49 weeks in the absence of disease progression or unacceptable toxicity.