Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Public ClinicalTrials.gov record NCT05920798. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MC220601, Folate Receptor Alpha Dendritic Cells (FRαDCs) Plus Pembrolizumab for Patients With Advanced Stage Ovarian Cancer (FRAPPE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05920798
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
- Fallopian Tube Carcinosarcoma
- Primary Peritoneal Carcinosarcoma
- Recurrent Fallopian Tube Carcinoma
- Recurrent Fallopian Tube Clear Cell Adenocarcinoma
- Recurrent Fallopian Tube Endometrioid Adenocarcinoma
- Recurrent Fallopian Tube High Grade Serous Adenocarcinoma
- Recurrent Ovarian Carcinoma
- Recurrent Ovarian Carcinosarcoma
- Recurrent Ovarian Clear Cell Adenocarcinoma
- Recurrent Ovarian Endometrioid Adenocarcinoma
- Recurrent Ovarian High Grade Serous Adenocarcinoma
- Recurrent Primary Peritoneal Carcinoma
- Recurrent Primary Peritoneal Clear Cell Adenocarcinoma
- Recurrent Primary Peritoneal Endometrioid Adenocarcinoma
- Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma
- Recurrent Primary Peritoneal Carcinosarcoma
Interventions
- Biopsy Procedure
- Biospecimen Collection Procedure
- Computed Tomography Procedure
- Magnetic Resonance Imaging Procedure
- Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine Biological
- Pembrolizumab Biological
- Pheresis Procedure
Procedure · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 27, 2023
- Primary completion
- Jun 29, 2028
- Completion
- Jun 29, 2028
- Last update posted
- Apr 5, 2026
2023 – 2028
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | Recruiting |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224-9980 | Recruiting |
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05920798, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 5, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05920798 live on ClinicalTrials.gov.