Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Eligible age
18+ yrs
Accepts
Women
Locations
3 states
Healthy volunteers
No
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About this study
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.
Sponsor: Mayo Clinic
You may qualify if…
- ✓ Age \>= 18 years
- ✓ Histologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer NOTE: Histologic confirmation of the primary tumor or recurrent tumor per pathology report is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRalpha. Mixed carcinomas, including carcinosarcomas, with \>= 50% of the tumor comprised of high grade serous; and/or endometrioid; and/or clear cell carcinoma are eligible
- ✓ Ovarian cancer (OC) recurrence - Platinum sensitivity/resistance
- ✓ Platinum-refractory (defined as recurrence or progression of OC =\< 30 days of the last dose of platinum-based chemotherapy)
- ✓ Platinum-resistant (defined as recurrence or progression of OC between 31-180 days of the last dose of platinum-based chemotherapy)
- ✓ Platinum-sensitive (defined as recurrence or progression \>=181 days after the last dose of platinum-based chemotherapy).
- ✓ NOTE: Any number of prior therapies or maintenance regimens for OC are allowed
- ✓ At least one of the following:
You may not qualify if…
- ✕ Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the developing fetus and newborn are unknown
- ✕ Pregnant persons
- ✕ Nursing persons
- ✕ Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception
- ✕ Prior treatment for ovarian cancer with an anti-PD-1 or anti-PD-L1 monoclonal antibody
- ✕ Treatment with IV anti-cancer therapy =\< 3 weeks prior to registration or with oral anti-cancer therapy =\< 1 week prior to registration NOTE: Since treatment will begin no sooner than 4 weeks after registration due to the need for apheresis and manufacturing of the FRαDC product, a "wash-out" period prior to registration will cause a gap of at least 5 weeks between the last anti-cancer treatment and initiation of protocol therapy
- ✕ Grade 2 or higher symptoms attributed to OC OR disease measuring \> 5 cm in long axis (non-nodal lesions), or \> 5 cm in short axis (nodal lesions) OR disease that, in the judgement of the treating investigator, is likely to become symptomatic in the next 8 weeks (ex. moderate ascites)
- ✕ NOTE: Since patients will not receive therapy for cancer until 3-4 weeks after apheresis--which is potentially 6-8 weeks after registration --patients with symptomatic OC or an elevated tumor burden may experience significant progression prior starting therapy and should not be treated on this protocol).
Where it's recruiting
Source: ClinicalTrials.gov · NCT05920798 · last updated 2026-04-06