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OncoMatch/Clinical Trials/NCT05920798

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

Is NCT05920798 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine and Pembrolizumab for fallopian tube carcinosarcoma.

Phase 1/2RecruitingMayo ClinicNCT05920798Data as of May 2026

Treatment: Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine · PembrolizumabThis 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.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: anti-PD-1 therapy

Prior treatment for ovarian cancer with an anti-PD-1 or anti-PD-L1 monoclonal antibody

Lab requirements

Blood counts

Hemoglobin ≥ 8.5 g/dL; ANC ≥ 1000/mm^3; Platelet count ≥ 75,000/mm^3; Lymphocytes ≥ 0.3 x 10^9/L; Monocytes ≥ 0.25 x 10^9/L

Kidney function

Creatinine clearance ≥ 30 mL/min per CKD-EPI equation

Liver function

Total bilirubin ≤ 1.5 x ULN (unless Gilbert's disease, then direct bilirubin ≤ ULN); AST ≤ 3 x ULN

Cardiac function

To be eligible, patients should be NYHA class 2B or better

Hemoglobin ≥ 8.5 g/dL ... ANC ≥ 1000/mm^3 ... Platelet count ≥ 75,000/mm^3 ... Lymphocytes ≥ 0.3 x 10^9/L ... Monocytes ≥ 0.25 x 10^9/L ... Total bilirubin ≤ 1.5 x ULN ... AST ≤ 3 x ULN ... Creatinine clearance ≥ 30 mL/min ... NYHA class 2B or better

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Mayo Clinic in Arizona · Scottsdale, Arizona
  • Mayo Clinic in Florida · Jacksonville, Florida
  • Mayo Clinic in Rochester · Rochester, Minnesota

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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