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NCT05920798 · ClinicalTrials.gov registry record · Phase 1
Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
A Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 3
- Study locations
NCT05920798 is a Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 40 participants, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (67% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05920798, a Phase 1 study of Recurrent Ovarian Carcinoma and Recurrent Fallopian Tube Carcinoma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-09-28 |
| Est. Completion | 2027-07-15 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05920798
The ClinicalTrials.gov registry entry for NCT05920798 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 39 other Recurrent Ovarian Carcinoma trials with a reported enrollment target (67% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Recurrent Ovarian Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05920798 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT05920798 about?
NCT05920798 is a clinical study titled "Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer". 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...
What is the current status of trial NCT05920798?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-09-28. Estimated completion is 2027-07-15.
What conditions does trial NCT05920798 study?
This clinical trial studies the following conditions: Recurrent Ovarian Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Clear Cell Adenocarcinoma, Recurrent Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Ovarian Endometrioid Adenocarcinoma.
What interventions are being tested in trial NCT05920798?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05920798?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05920798 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.