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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
Select...
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response rate (complete response [CR] + partial response [PR])
Secondary outcome measures
Biomarker analysis
Clinical benefit (CR+PR+ stable disease [SD] > 6 months)
Incidence of adverse events
+2 more

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 2
~1950

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
558 Previous Clinical Trials
1,917,423 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,617 Total Patients Enrolled
23 Trials studying Fallopian Tube Carcinoma
6,798 Patients Enrolled for Fallopian Tube Carcinoma
Mihaela C CristeaPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
44 Total Patients Enrolled

Media Library

Modified Vaccinia Virus Ankara Vaccine Expressing p53 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03113487 — Phase 2
Fallopian Tube Carcinoma Research Study Groups: Treatment (pembrolizumab, p53MVA)
Fallopian Tube Carcinoma Clinical Trial 2023: Modified Vaccinia Virus Ankara Vaccine Expressing p53 Highlights & Side Effects. Trial Name: NCT03113487 — Phase 2
Modified Vaccinia Virus Ankara Vaccine Expressing p53 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03113487 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being evaluated in this experiment?

"Currently, this trial is not seeking any new patients. Posted on February 1st 2018 and last updated September 28th 2022, there are several other treatments with open studies for fallopian tube carcinoma; 3374 trials to be exact. Moreover, 975 clinical trials featuring Pembrolizumab are presently admitting participants."

Answered by AI

What is the current regulatory status of Pembrolizumab?

"A score of 2 was given to Pembrolizumab for its safety rating, as clinical data has verified that it is safe, but there have not been any trials demonstrating efficacy."

Answered by AI

Has Pembrolizumab been investigated in any additional research projects?

"At this time, there are 975 medical trials investigating pembrolizumab. Of those active studies, 122 have progressed to the third phase of clinical testing. The majority of these experiments take place in Houston, Texas but 35804 other facilities are conducting research into this treatment as well."

Answered by AI

Are there still opportunities for patients to participate in this research?

"As of this moment, enrolling patients into the trial is not available. It was initially posted on February 1st 2018 and last updated September 28th 2022. As an alternative, there are presently 3374 clinical trials for fallopian tube carcinoma actively recruiting and 975 studies that utilize Pembrolizumab in search of participants."

Answered by AI

In what capacity is Pembrolizumab usually employed?

"Pembrolizumab is frequently used as a form of treatment for cancerous neoplasms. Additionally, it can be employed to treat issues like advanced melanoma, microsatellite instability-high tumours, and the recurrence of symptoms after chemotherapy."

Answered by AI
~0 spots leftby Mar 2024