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Virus Therapy

P53MVA + Pembrolizumab for Ovarian Cancer

Phase 2

Waitlist Available

Led By Mihaela C Cristea

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

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 and a life expectancy of at least 3 months

Participants with histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tube cancer who have experienced recurrence or progression within 6 months after completion of platinum-based chemotherapy by RECIST 1.1 criteria

Must not have

Received prior systemic anti-cancer therapy within 4 weeks prior to treatment start

Active infection requiring systemic therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well a modified virus vaccine and pembrolizumab work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions from vaccines like soreness at injection site and flu-like symptoms, as well as those related to immunotherapy such as fatigue, skin reactions, inflammation in organs like lungs or intestines, hormonal gland problems and changes in blood test results.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My ovarian, peritoneal, or fallopian tube cancer has returned or worsened within 6 months after platinum chemotherapy.

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My cancer has a p53 mutation or shows high levels of p53.

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I am not pregnant, not breastfeeding, and can follow birth control guidelines if needed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am currently being treated for an infection.

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I do not have a history of serious heart conditions or uncontrolled high blood pressure.

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My family has a history of Li-Fraumeni syndrome.

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I have a history of HIV, hepatitis B, hepatitis C, or active TB.

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I have had or currently have lung inflammation treated with steroids.

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I have another cancer that is getting worse or was treated in the last 3 years.

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My cancer has spread to my brain or its coverings.

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I have an immune system disorder or have taken steroids in the past week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of Patients Achieving Complete or Partial Response

Secondary study objectives

Clinical Benefit Rate

Overall Survival

Progression-free Survival

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 (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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 13Eligibility criteria met