RecruitingPhase 1Phase 2NCT05920798

Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer

MC220601, Folate Receptor Alpha Dendritic Cells (FRαDCs) Plus Pembrolizumab for Patients With Advanced Stage Ovarian Cancer (FRAPPE)


Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Sep 28, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This phase I/II trial tests the safety, side effects, best dose, and effectiveness of multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRalphaDC) with pembrolizumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer (collectively known as ovarian cancer) that that has come back (after a period of improvement) (recurrent). Ovarian cancer is the most lethal gynecologic malignancy in the United States. While the majority of patients achieve a remission from ovarian cancer with the combination of aggressive cytoreductive surgery and cytotoxic chemotherapy, over 80% of patients develop recurrence within 3 years of completion of treatment. Additional treatments are needed for recurrence, but the standard treatment modalities are non-curative in nature due to the development of drug resistance. As such, there is a great unmet need for treatment strategies that utilize new mechanisms to which drug resistance does not develop. FRalphaDC is a dendritic cell vaccine that is made from the white blood cells collected from a procedure call apheresis. The white blood cells are treated to make dendritic cells, which will then be incubated with peptides, which are pieces of a protein known as "folate receptor alpha" (FRalpha), a protein that is found in high levels on ovarian cancer cells. Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the tumor cells by targeting the FRalpha protein. 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 FRalphaDC vaccine with pembrolizumab may be a safe and effective treatment for recurrent ovarian cancer.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a vaccine-based treatment combined with the immunotherapy drug pembrolizumab for women with recurrent ovarian, fallopian tube, or peritoneal cancer. The vaccine targets a protein called folate receptor alpha (FRα), which is found in high amounts on these cancer cells. The goal is to train the immune system to recognize and attack the cancer. **You may be eligible if:** - You are 18 years or older - You have recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer confirmed by biopsy - Your cancer is of a specific subtype: high-grade serous, endometrioid, or clear cell carcinoma (or a mix where these make up at least 50%) - Your cancer has come back regardless of whether it was platinum-sensitive, platinum-resistant, or platinum-refractory - You have measurable disease on imaging OR elevated CA-125 levels - You are in good physical health (ECOG 0 or 1) with adequate blood counts and organ function **You may NOT be eligible if:** - Your cancer is a different subtype (e.g., mucinous or low-grade serous without the required histological features) - You have active autoimmune disease requiring systemic treatment - You have had prior severe reactions to pembrolizumab or similar drugs - Your blood counts or organ function do not meet study requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiopsy

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREComputed Tomography

Undergo CT

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALMulti-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine

Given ID

BIOLOGICALPembrolizumab

Given IV

PROCEDUREPheresis

Undergo apheresis


Locations(3)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

View Full Details on ClinicalTrials.gov

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NCT05920798


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