Study on P53MVA and Pembrolizumab for Treating Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40

ClinicalTrials ID:NCT03113487

Provider View

This clinical trial is testing a combination of a vaccine and an immunotherapy drug to see if they can help treat ovarian, primary peritoneal, or fallopian tube cancer that has returned after treatment.

Patient Parameters

Program Overview

This study is exploring whether a vaccine called p53MVA, combined with the immunotherapy drug pembrolizumab, can help the immune system fight ovarian, primary peritoneal, or fallopian tube cancer that has come back. The vaccine is designed to help the body recognize and attack cancer cells, while pembrolizumab helps the immune system target and destroy these cells. The goal is to see if this combination can better control the cancer compared to other treatments.

Description

The main goal of this study is to see how well the combination of p53MVA and pembrolizumab works in shrinking tumors in patients with recurrent ovarian, primary peritoneal, or fallopian tube cancer. Researchers will also look at how long patients live without the cancer getting worse, overall survival rates, and how safe and tolerable the treatment is.

Participants will receive pembrolizumab through an IV every three weeks and the p53MVA vaccine as a shot under the skin every three weeks, for up to three doses. Pembrolizumab treatment can continue every three weeks for up to 49 weeks, as long as the cancer does not progress and side effects are manageable.

After finishing the treatment, patients will have follow-up visits 1-3 weeks later and then every 12 weeks to monitor their health and the cancer's status.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of ovarian, primary peritoneal, or fallopian tube cancer that has returned within 6 months after finishing platinum-based chemotherapy.
  • Not be pregnant or breastfeeding, and agree to use effective birth control during the study and for 30 days after the last treatment.
  • Provide written informed consent to participate in the study.
  • Have measurable or detectable disease based on specific medical criteria.
  • Have a confirmed p53 mutation or overexpression in the tumor.
  • Be in relatively good health with a performance status score of 0 to 2 and a life expectancy of at least 3 months.
  • Have had up to 4 prior chemotherapy treatments for recurrent cancer.
  • Meet specific blood count and organ function requirements based on recent tests.
  • Not have received any non-cancer vaccines within 30 days before starting the study treatment.

Exclusion Criteria

  • Be pregnant or breastfeeding.
  • Have received certain prior cancer treatments or vaccines within a specified time before starting the study.
  • Have a diagnosis of immunodeficiency or be on immunosuppressive therapy.
  • Have another active cancer or a history of severe allergic reactions to pembrolizumab.
  • Have active infections or certain viral infections like hepatitis or HIV.
  • Have a history of severe heart disease or other serious medical conditions that could interfere with the study.
  • Have a known psychiatric or substance abuse disorder that would affect participation in the study.
  • Have a family history of Li-Fraumeni syndrome.

Locations

FACILITYZIPCITYSTATE
City of Hope Medical Center91010DuarteCalifornia

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