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New treatment option for Fallopian Tube Carcinosarcoma
Official title Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
ClinicalTrials.gov ID: NCT05920798
What this study is testing
What is Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine?
Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for fallopian tube carcinosarcoma.
Also referred to as FRaDC Vaccine, FRalphaDC Vaccine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Age \>= 18 years
- Histologically confirmed recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer NOTE: Histologic confirmation of the primary...
- 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)
You likely can't join if
- Any of the following because this study involves an investigational agent, the genotoxic, mutagenic and teratogenic effects of which on the...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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:
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- History of allogeneic stem cell transplant
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.