Study on FRaDCs and Pembrolizumab for Advanced Ovarian Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05920798

Provider View

This clinical trial is testing a new treatment combining folate receptor alpha dendritic cells (FRaDCs) and pembrolizumab to see if it can help the immune system fight advanced ovarian, fallopian tube, or primary peritoneal cancer.

Patient Parameters

Program Overview

The aim of this study is to find out if a new combination of treatments, FRaDCs and pembrolizumab, can effectively help the immune system attack and reduce tumors in patients with advanced ovarian, fallopian tube, or primary peritoneal cancer. The treatment involves using a vaccine made from a patient's own white blood cells, which are treated to help the body build a strong immune response against cancer cells.

Description

This study is divided into two phases. In Phase I, researchers will check if the combination of FRaDCs and pembrolizumab is safe for patients with recurrent ovarian cancer. In Phase II, they will measure how well this combination works in shrinking tumors.

The study also aims to understand how long the treatment can control the disease, how long patients live without the disease getting worse, and the overall survival rate. Researchers will also look at any side effects and how the treatment affects the immune system.

Participants will undergo a procedure called apheresis to collect white blood cells, which will be used to make the FRaDC vaccine. They will receive the vaccine and pembrolizumab through injections and infusions. Throughout the trial, participants will have regular scans and blood tests to monitor their health and the treatment's effects. Follow-up visits will continue for up to five years to track long-term outcomes.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of recurrent ovarian, fallopian tube, or primary peritoneal cancer.
  • Cancer must be one of the specific types that express high levels of folate receptor alpha.
  • Cancer must have returned after previous treatment, with specific criteria for platinum sensitivity.
  • Must have measurable disease or elevated CA-125 levels.
  • Must be in good overall health with an ECOG performance status of 0 or 1.
  • Must meet specific blood count and organ function requirements.
  • Must not be pregnant and must agree to use contraception if of childbearing potential.
  • Must be willing to provide blood and tissue samples for research.
  • Must be willing to return for follow-up visits and undergo a tetanus vaccination if needed.

Exclusion Criteria

  • Pregnant or nursing individuals, or those not willing to use contraception.
  • Previous treatment with anti-PD-1 or anti-PD-L1 antibodies for ovarian cancer.
  • Recent treatment with other cancer therapies.
  • Severe symptoms or large tumors that may worsen before treatment starts.
  • Serious health conditions that could interfere with the study.
  • Active infections or autoimmune diseases requiring treatment.
  • Other active cancers needing treatment.
  • Recent heart attack or severe heart disease.
  • Use of certain immunosuppressive medications before the study.
  • History of stem cell transplant.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.