[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-peritoneal-carcinosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-peritoneal-carcinosarcoma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,56,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":5},"100510004","phase-1-vaccine-therapy-plus-pembrolizumab-in-treating-advanced-ovarian-fallopian-tube-or-primary-peritoneal-cavity-cancer-100510004",false,"NCT05920798","Vaccine Therapy Plus Pembrolizumab in Treating Advanced Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer","MC220601, Folate Receptor Alpha Dendritic Cells (FRαDCs) Plus Pembrolizumab for Patients With Advanced Stage Ovarian Cancer (FRAPPE)","FRAPPE","Inclusion Criteria:\n\n* Age \\>= 18 years\n* 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\u002For endometrioid; and\u002For clear cell carcinoma are eligible\n* Ovarian cancer (OC) recurrence - Platinum sensitivity\u002Fresistance\n\n  * Platinum-refractory (defined as recurrence or progression of OC =\\\u003C 30 days of the last dose of platinum-based chemotherapy)\n  * Platinum-resistant (defined as recurrence or progression of OC between 31-180 days of the last dose of platinum-based chemotherapy)\n  * Platinum-sensitive (defined as recurrence or progression \\>=181 days after the last dose of platinum-based chemotherapy).\n\nNOTE: Any number of prior therapies or maintenance regimens for OC are allowed\n\n* At least one of the following:\n\n  * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria AND\u002FOR\n  * CA-125-evaluable disease, as defined by the Gynecologic Cancer InterGroup (GCIG)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* Hemoglobin \\>= 8.5 g\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Platelet count \\>= 75,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Lymphocytes \\>= 0.3 x 10\\^9\u002FL (obtained =\\\u003C 15 days prior to registration)\n* Monocytes \\>= 0.25 x 10\\^9\u002FL (obtained =\\\u003C 15 days prior to registration)\n* Total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin must be =\\\u003C ULN (obtained =\\\u003C 15 days prior to registration)\n* Aspartate transaminase (AST) =\\\u003C 3 x ULN (obtained =\\\u003C 15 days prior to registration)\n* Creatinine clearance \\>= 30 mL\u002Fmin per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent\n* Willing to provide mandatory blood and tissue specimens for correlative research\n* Willing to provide archival tissue specimen for correlative research\n* Willing to return to Mayo Clinic for follow-up (during the active monitoring phase of the study)\n* Willing to undergo a tetanus vaccination (if not performed =\\\u003C 365 days prior to registration)\n* Willing to have a temporary central access line placed for apheresis, if needed\n\nExclusion Criteria:\n\n* 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\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Prior treatment for ovarian cancer with an anti-PD-1 or anti-PD-L1 monoclonal antibody\n* Treatment with IV anti-cancer therapy =\\\u003C 3 weeks prior to registration or with oral anti-cancer therapy =\\\u003C 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\n* 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)\n\n  * 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).\n* 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\n* Uncontrolled human immunodeficiency virus (HIV) infection and\u002For HIV-infected patients with a history of Kaposi's sarcoma and\u002For multicentric Castleman disease.\n\n  * NOTE: HIV-infected participants must have well-controlled HIV on anti-retroviral therapy (ART), defined as:\n\n    * Participants on ART must have a CD4+ T-cell count ≥ 350 cells\u002Fmm\\^3 at the time of screening\n    * 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\n    * It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months\n    * 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\n  * NOTE: No HIV testing is required unless mandated by local health authority\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active serious infections (e.g., pneumonia, sepsis) requiring systemic therapy\n  * Current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids\n  * Active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) =\\\u003C 2 years prior to registration\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Concurrent active hepatitis B \\[defined as hepatitis B surface antigen (HBsAg) positive and\u002For 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:\n\n    * 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\n\n      * 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\n    * Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load.\n\n      * NOTE: Patients must have completed curative anti-viral treatment \\>= 4 weeks prior to registration\n  * NOTE: Patients without symptoms or prior history do not require testing prior to registration unless mandated by local health authority\n* Other active malignancy either requiring palliative systemic therapy =\\\u003C 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\n* History of myocardial infarction =\\\u003C 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\n* Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone \\>10 mg\u002Fday or equivalent, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[TNF\\]-alpha agents) =\\\u003C 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 (=\\\u003C 10 mg\u002Fday oral prednisone or equivalent) prior to registration or a one-time pulse dose of systemic immunosuppressant medication (e.g., =\\\u003C 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\n* History of allogeneic stem cell transplant","FEMALE","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This phase I\u002FII 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.",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43],"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","RECRUITING","2026-03-31",{"date":47,"type":48},"2026-04-06","ACTUAL",{"date":50,"type":48},"2023-09-28",{"date":52,"type":21},"2028-06-30",{"name":54,"class":55},"Mayo Clinic","OTHER",{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100433092","phase-2-apl-2-and-pembrolizumab-versus-apl-2-pembrolizumab-and-bevacizumab-versus-bevacizumab-alone-for-the-treatment-of-recurrent-ovarian-fallopian-tube-or-primary-peritoneal-cancer-and-malignant-effusion-100433092","NCT04919629","APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion","Randomized Phase 2 Trial of APL-2 With Pembrolizumab vs. APL-2 With Pembrolizumab and Bevacizumab vs. Bevacizumab Alone in Patients With Recurrent Ovarian Cancer and Persistent Malignant Effusion","Inclusion Criteria:\n\n* Age \\>= 18 years of age on day of signing informed consent\n* Recurrent epithelial ovarian\u002Ffallopian tube or primary peritoneal cancer (serous, clear cell, endometrioid, mixed or poorly differentiated or carcinosarcoma) based on imaging or synchronous primary ovarian and uterine cancer patients with any of the histology subtypes mentioned above regardless of platinum sensitivity, prior stage or number of prior treatment lines\n* Symptomatic ascites or pleural effusion or both requiring \\>= 1 drainage within 4-weeks of study entry or has a peritoneal\u002Fpleural drainage catheter in place to control symptoms\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Patient has not received pembrolizumab or other immune checkpoint inhibitor treatment for 9 weeks prior to enrollment\n* Life expectancy of \\>= 3 months\n* Absolute neutrophil count (ANC): \\>= 1,500\u002FµL\n* Platelets: \\>= 75,000\u002FµL\n* Hemoglobin: \\>= 9 g\u002FdL or 5.6 mmol\u002FL (within 7 days of assessment)\n* Creatinine: =\\\u003C 1.5 X upper limit of normal (ULN) OR measured or calculated creatinine clearance \\>= 60 mL\u002Fmin (Cockcroft-Gault Equation) for participant with creatinine levels \\> 1.5 X institutional ULN. GFR can also be used in place of creatinine or creatinine clearance (CrCl)\n* Total bilirubin: =\\\u003C 1.5 X ULN OR direct bilirubin =\\\u003C ULN for participants with total bilirubin levels \\> 1.5 ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]): =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for participants with liver metastases\n* Albumin: \\> 2.5 gm\u002FdL\n* International Normalized Ratio (INR) or Prothrombin Time (PT): =\\\u003C 1.5 unless participant is receiving anticoagulant therapy as long as PT or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants\n* Activated Partial Thromboplastin Time (aPTT): =\\\u003C 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants\n* A woman of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Participants of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication (participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \\> 1 year). Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately\n* Willing and able to self-administer APL-2 (administration by caregiver will be allowed)\n* No known absolute contraindication to bevacizumab and\u002For pembrolizumab treatment per enrolling provider\n* Willing to receive vaccination against Neisseria meningitidis, Streptococcus pneumoniae, and Hemophilus influenzae if randomized into an APL-2 receiving arm, if not already vaccinated\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Is currently receiving any additional cancer therapy or participating or used an investigational drug or device within 3 weeks of the first dose of treatment\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment or, is taking any other medication that might affect immune function\n* Has active autoimmune disease that has required systemic treatment in the past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment\n* Has an active infection requiring systemic therapy\n* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator\n* Participant has clinically significant cardiovascular disease including:\n\n  * Uncontrolled hypertension, defined as systolic \\>150 mmHg or diastolic \\>90 mmHg\n  * Myocardial infarction or unstable angina within 6 months prior to enrollment\n  * New York Heart Association (NYHA) Grade II or greater congestive heart failure\n  * Participant has a Grade II (NYHA) or greater peripheral vascular disease\n  * Participant has a clinically significant peripheral artery disease (e.g. those with claudication), within 6 months prior to study enrollment\n* Pregnancy or lactation\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug\n* Has a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or has current pneumonitis\u002Finterstitial lung disease.\n* Has a known history of human immunodeficiency virus (HIV) infection\n* Concurrent active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] positive and\u002For detectable HBV deoxyribonucleic acid \\[DNA\\]) and hepatitis C virus (HCV) (defined as anti-HCV Ab positive and detectable HCV ribonucleic acid \\[RNA\\]) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection\n* Has received any investigational vaccines (i.e., those not licensed or approved for emergency use). Note: Any licensed COVID-19 vaccine (including for Emergency Use) is allowed in the study as long as they are modified ribonucleic acid (mRNA) vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (i.e., those not licensed or approved for emergency use) are not allowed\n* Known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded",{"count":64,"type":21},60,[25],"This phase II trial studies the effect of APL-2 when given in combination with either pembrolizumab or pembrolizumab and bevacizumab compared with bevacizumab alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) and a buildup of fluid and cancer cells (malignant effusion). APL-2 may limit tumor progression, decrease malignant effusion production, and improve the immune system's response against cancer cells. 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. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving APL-2 together with either pembrolizumab or pembrolizumab and bevacizumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer and malignant effusion compared to bevacizumab alone.",[28,68,69,70,71,72,73,74,29,75,76,77,30,34,39],"Fallopian Tube Clear Cell Adenocarcinoma","Fallopian Tube Endometrioid Adenocarcinoma","Fallopian Tube Serous Adenocarcinoma","Ovarian Carcinosarcoma","Ovarian Clear Cell Adenocarcinoma","Ovarian Endometrioid Adenocarcinoma","Ovarian Serous Adenocarcinoma","Primary Peritoneal Clear Cell Adenocarcinoma","Primary Peritoneal Endometrioid Adenocarcinoma","Primary Peritoneal Serous Adenocarcinoma","2026-03-19",{"date":80,"type":48},"2026-03-23",{"date":82,"type":48},"2023-04-27",{"date":84,"type":21},"2028-04-30",{"name":86,"class":55},"Roswell Park Cancer Institute",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":22,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":5},"100565199","phase-2-folate-receptor-alpha-dendritic-cells-frdcs-or-placebo-for-the-treatment-of-patients-with-stage-iii-or-iv-ovarian-fallopian-tube-or-primary-peritoneal-cancer-farout-trial-100565199","NCT06639074","Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for the Treatment of Patients With Stage III or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, FAROUT Trial","MC1963 Folate Receptor Alpha Dendritic Cells (FRαDCs) or Placebo for Patients With Advanced Stage Ovarian Cancer: A Phase II Double-Blind Randomized Clinical Trial (FAROUT)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histological confirmation of Federation of Gynecology and Obstetrics (FIGO) stage III or stage IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. NOTE: Histologic confirmation of the primary tumor is required. Eligible histotypes include high grade serous; endometrioid; and clear cell carcinoma, as these histotypes have high expression of FRα (Kalli, Oberg, Keeney, \\& et al., 2008). Mixed carcinomas, including carcinosarcomas, with ≥ 50% of the tumor comprised of high grade serous; and\u002For endometrioid; and\u002For clear cell carcinoma are eligible\n* Completion of cytoreductive surgery and one (and only one) course of platinum-based chemotherapy (5-9 cycles) ≥ 4 but ≤ 12 weeks prior to registration\n\n  * NOTE: Cytoreductive surgery may have been prior to or after one or more cycles of chemotherapy and must include hysterectomy and bilateral salpingo-oophorectomy (if the uterus and\u002For ovaries were not previously removed)\n  * NOTE: Patients may have had more than one chemotherapy regimen (examples: paclitaxel\u002Fcarboplatin switched to docetaxel\u002Fcarboplatin due to allergy; or weekly treatment switched to every 3-weekly treatment due to intolerance), but may not have received a separate course of treatment for recurrent OC\n  * NOTE: Patients may receive both neoadjuvant and adjuvant chemotherapy provided both regimens are platinum-based and total nine (9) or fewer chemotherapy cycles\n* Germline and somatic genetic testing have been completed\n\n  * NOTE: No pathogenic mutations of BRCA1\u002FBRCA2 are allowed\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Expected survival ≥ 6 months\n* Hemoglobin ≥ 8.5 g\u002FdL (≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm\\^3 (≤ 15 days prior to registration)\n* Platelet count ≥ 75,000\u002Fmm\\^3 (≤ 15 days prior to registration)\n* Lymphocytes ≥ 0.3 x 10\\^9\u002FL (≤ 15 days prior to registration)\n* Monocytes ≥ 0.25 x 10\\^9\u002FL (≤ 15 days prior to registration)\n* Total bilirubin ≤ upper limit of normal (ULN), unless patient has a documented history of Gilbert's disease, then direct bilirubin ≤ ULN (≤ 15 days prior to registration)\n* Aspartate transaminase (AST) ≤ 3 x ULN (≤ 15 days prior to registration)\n* Creatinine clearance ≥ 30 mL\u002Fmin per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (≤ 15 days prior to registration)\n* Provide written informed consent\n* Willing to provide mandatory blood specimens for correlative research\n* Willing to provide archival tissue specimen for correlative research\n* Willing to return a participating institution for follow-up (during the active monitoring phase of the study)\n* Willing to undergo a tetanus vaccination (if not performed ≤ 365 days prior to registration)\n* Willing to have a central access line placed, if needed (as determined during venous access assessment)\n\nExclusion Criteria:\n\n* 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\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Evidence of disease at the time of registration, including clinical concern for disease recurrence based on each of the following:\n\n  * Evidence of disease by history and physical exam\n  * CA125 outside institutional normal limits\n  * CT (and or MRI) of the chest\u002Fabdomen\u002Fpelvis demonstrating radiological evidence of disease performed after completion of chemotherapy ≤ 28 days be-fore entering study\n* Germline or somatic BRCA1 or BRCA2 mutation, as determined by Clinical Laboratory Improvement Act (CLIA)-approved tests\n* Prior radiation therapy for this cancer\n* Treatment with chemotherapy, angiogenesis inhibitor therapy, poly (ADP-ribose) polymerase (PARP) inhibitor therapy, radiation therapy, or other immunotherapy ≤ 4 weeks prior to registration\n* Receiving any other standard therapy (angiogenesis inhibitor, PARP inhibitor) or investigational agent, which would be considered as a treatment for the primary neoplasm. These agents have been shown to be active in later line therapy and can be used at that time for patients who relapse after treatment on this trial\n* 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\n* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy\n\n  * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * EXCEPTIONS: HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For patients with evidence of hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Other active malignancy ≤ 3 years prior to registration\n\n  * 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. (Contact site principal investigator \\[PI\\] if questions.)\n* History of myocardial infarction ≤ 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n\n  * 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\n* Treatment with systemic immunosuppressive medication (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[TNF\\]-alpha agents) ≤ 2 weeks prior to registration, or anticipation of need for systemic immunosuppressive medication during the course of the study\n\n  * NOTE: Patients who have received acute, low-dose systemic steroids (≤ 10 mg\u002Fday 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\n  * 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",{"count":96,"type":21},78,[25],"This phase II trial compares the effect of folate receptor alpha dendritic cells (FRαDCs) to placebo in treating patients with stage III or IV ovarian, fallopian tube or primary peritoneal cancer. FRαDCs, a dendritic cell vaccine, is made from a person's white blood cells. The white blood cells are treated in the laboratory to make dendritic cells (a type of immune cell) mixed with folate receptor alpha (FRalpha), a protein found in high levels on ovarian tumor cells. FRαDCs work by boosting the immune system to recognize and destroy the tumor cells by targeting the FRalpha protein on the tumor cell. Placebo is an inactive substance that looks the same as, and is given the same way as, the active drug or treatment being tested. The effects of the active drug are compared to the effects of the placebo. Giving FRαDCs may work better in preventing or delaying recurrence compared to placebo in patients with stage III or IV ovarian, fallopian tube, or primary peritoneal cancer.",[100,101,102,103,104,105,106,107,108,28,68,69,109,110,111,29,75,76],"Advanced Fallopian Tube Carcinoma","Advanced Fallopian Tube High Grade Serous Adenocarcinoma","Advanced Ovarian Carcinoma","Advanced Ovarian Carcinosarcoma","Advanced Ovarian Clear Cell Adenocarcinoma","Advanced Ovarian Endometrioid Adenocarcinoma","Advanced Ovarian High Grade Serous Adenocarcinoma","Advanced Primary Peritoneal Carcinoma","Advanced Primary Peritoneal High Grade Serous Adenocarcinoma","FIGO Stage III Ovarian Cancer 2014","FIGO Stage IV Ovarian Cancer 2014","Ovarian Mixed Cell Adenocarcinoma","2025-09-29",{"date":114,"type":48},"2025-10-02",{"date":116,"type":48},"2024-11-08",{"date":118,"type":21},"2027-12-31",{"name":54,"class":55}]