Vaccine Therapy Plus Pembrolizumab for Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
This study is testing a combination of two treatments for advanced ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent). The treatments are a multi-epitope folate receptor alpha-loaded dendritic cell vaccine (FRalphaDC) and pembrolizumab. Researchers want to see if this combination is safe and how well it works to shrink tumors. You may be able to join if you are a woman aged 18 or older with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The study aims to enroll 40 participants and is currently unclear if it is recruiting.
- Study design
- This is an interventional study with a planned enrollment of 40 women. It is testing the safety and effectiveness of a vaccine therapy combined with pembrolizumab.
- What's involved
- You would undergo procedures such as biopsies, blood sample collections, CT scans, and MRI scans. You would also receive the multi-epitope folate receptor alpha-loaded dendritic cell vaccine.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will confirm objective response rate (tumor shrinkage) for up to 5 years after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05920798
Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
Recruiting
PHASE1Ages 18+InterventionalTreatmentMayo ClinicInvestigator-initiated
~40 participants
Updated 2026-04-06 on ClinicalTrials.gov
What's tested:BiopsyBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingMulti-epitope Folate Receptor Alpha-loaded Dendritic Cell VaccinePembrolizumab
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine whether the combination of FRαDCs and pembrolizumab has an acceptable toxicity profile.
Measured over Up to 21 days
+1 more outcome measured
Conditions
Where it's being run
3 sites across 3 statesArizona1
Florida1
Minnesota1
Study leadership
- Matthew S. Block, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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).
At least one of the following:
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria AND/OR
CA-125-evaluable disease, as defined by the Gynecologic Cancer InterGroup (GCIG)
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Hemoglobin \>= 8.5 g/dL (obtained =\< 15 days prior to registration)
Absolute neutrophil count (ANC) \>= 1000/mm\^3 (obtained =\< 15 days prior to registration)
Platelet count \>= 75,000/mm\^3 (obtained =\< 15 days prior to registration)
Lymphocytes \>= 0.3 x 10\^9/L (obtained =\< 15 days prior to registration)
Monocytes \>= 0.25 x 10\^9/L (obtained =\< 15 days prior to registration)
Total bilirubin =\< 1.5 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin must be =\< ULN (obtained =\< 15 days prior to registration)
Aspartate transaminase (AST) =\< 3 x ULN (obtained =\< 15 days prior to registration)
Creatinine clearance \>= 30 mL/min per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (obtained =\< 15 days prior to registration)
Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only
Provide written informed consent
Willing to provide mandatory blood and tissue specimens for correlative research
Willing to provide archival tissue specimen for correlative research
Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)
Willing to undergo a tetanus vaccination (if not performed =\< 365 days prior to registration)
Willing to have a temporary central access line placed for apheresis, if needed
Exclusion
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).
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Uncontrolled human immunodeficiency virus (HIV) infection and/or HIV-infected patients with a history of Kaposi's sarcoma and/or multicentric Castleman disease.
NOTE: HIV-infected participants must have well-controlled HIV on anti-retroviral therapy (ART), defined as:
Participants on ART must have a CD4+ T-cell count ≥ 350 cells/mm\^3 at the time of screening
Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV ribonucleic acid (RNA) level below 50 or the lower limit of quantification derivation technique (LLOQ) (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening
It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months
Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (day 1) and agree to continue ART throughout the study
NOTE: No HIV testing is required unless mandated by local health authority
Uncontrolled intercurrent illness including, but not limited to:
Ongoing or active serious infections (e.g., pneumonia, sepsis) requiring systemic therapy
Current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids
Active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) =\< 2 years prior to registration
Psychiatric illness/social situations that would limit compliance with study requirements
Concurrent active hepatitis B \[defined as hepatitis B surface antigen (HBsAg) positive and/or detectable hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \] and Hepatitis C virus \[defined as anti-hepatitis C virus (HCV) antibody (Ab) positive and detectable HCV RNA\] infection. EXCEPTIONS:
For patients with evidence of hepatitis B virus (HBV) infection (HBsAg positive), patients must have completed at least 4 weeks of hepatitis B virus (HBV) antiviral therapy and the HBV viral load must be undetectable at the time of registration
NOTE: Patients should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention
Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load.
NOTE: Patients must have completed curative anti-viral treatment \>= 4 weeks prior to registration
NOTE: Patients without symptoms or prior history do not require testing prior to registration unless mandated by local health authority
Other active malignancy either requiring palliative systemic therapy =\< 3 years prior to registration, or likely to require treatment in the next 2 years EXCEPTIONS: Patients with non-melanotic skin cancer, papillary thyroid cancer not requiring therapy or carcinoma-in-situ are eligible for this trial. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
History of myocardial infarction =\< 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias NOTE: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone \>10 mg/day or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \[TNF\]-alpha agents) =\< 7 days prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study NOTE: Patients who have received acute, low-dose systemic steroids (=\< 10 mg/day oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., =\< 48 hours of corticosteroids for a contrast allergy) are eligible for the study NOTE: The use of inhaled corticosteroids for chronic obstructive pulmonary disease or asthma, mineralocorticoids (e.g., fludrocortisone), or low-dose corticosteroids for patients with orthostatic hypotension or adrenocortical insufficiency is allowed
History of allogeneic stem cell transplant
What this trial measures
- Determine whether the combination of FRαDCs and pembrolizumab has an acceptable toxicity profile.Up to 21 days
Three patients will be enrolled to starting dose (dose level 1) and enrollment will pause until each of the first 3 patients have completed cycle 1 of therapy. If zero or one of first 3 patients develops a dose limiting toxicity (DLT) during cycle 1, 3 more patients will be enrolled to dose level 1. If observe at most 1 DLT in the first 6 patients at dose level 1, it will be considered safe and will continue in phase II of trial. If 2 or more of the first 6 patients develop a DLT during cycle 1 for dose level 1, then enrollment will stop and dose level will be decreased. Additional patients will be enrolled in cohorts of 3 to that decreased dose level. If zero or one DLT in the first 6 patients at dose level -1, it will be considered safe and will continue in phase II of trial. Otherwise, if observe 2 or more DLTs in the first 6 patients of dose level -1, enrollment will stop until the Study Team adjusts the treatment plan with input from the Data Safety Monitoring Board.
- Confirm objective response rate (ORR)Up to 5 years
Defined as the proportion of patients with a complete response (CR) or partial response (PR). If at least 7 confirmed responses are observed in the first 32 eligible patients (22%), the combination treatment will be considered worthy of further investigation.