[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-primary-peritoneal-carcinosarcoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-primary-peritoneal-carcinosarcoma":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,57],{"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":56},"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",3,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100553204","phase-1-muc1-activated-t-cells-for-the-treatment-of-relapsed-and-resistant-ovarian-cancer-100553204","NCT06483048","MUC1-Activated T Cells for the Treatment of Relapsed and Resistant Ovarian Cancer","Phase 1 Clinical Trial Using Autologous, MUC1-Activated T Cells Expanded From Peripheral Blood in Patients With Relapsed and Resistant Ovarian Cancer","Inclusion Criteria:\n\n* PRE-REGISTRATION: Age ≥ 18 years\n* PRE-REGISTRATION: Diagnosis or history of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer\n* PRE-REGISTRATION: Patients must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria on study entry, which must include at least 1 lesion that has a single diameter of ≥ 1 cm measured by CT or MRI or the CT portion of the PET\u002FCT\n\n  * Skin lesions can be used if the area is ≥ 1cm in at least one diameter and measured with a ruler\n* PRE-REGISTRATION: Relapsed or refractory ovarian cancer previously treated with or intolerant to at least one prior line of therapy with platinum chemotherapy and be relapsed or have tumor evaluable for response if in first line setting resistant or ineligible to platinum. Patients with BRCA1\u002F2 mutations must have received prior treatment with a poly (ADP-ribose) polymerase (PARP) inhibitor to be eligible. Platinum-resistance is defined as any of the following occurring \\\u003C 183 days after the last dose of platinum-based chemotherapy:\n\n  * Development of measurable disease (per RECIST 1.1)\n  * Progression of radiographic disease (per RECIST 1.1)\n  * Increase in CA-125 level to ≥ 2 x upper limit of normal (ULN) (if within normal limits \\[WNL\\] at the completion of platinum-based chemotherapy)\n  * Increase in CA-125 level to ≥ 2 x nadir (if nadir \\> ULN)\n  * If CA-125 is used to determine the date of progression then it must be confirmed by a second CA-125 value ≥ 7 days after the first level and concurrent with imaging changes. The date of the first qualifying CA-125 is used to compute the platinum-free interval\n* PRE-REGISTRATION: Provide written informed consent\n* PRE-REGISTRATION: Willingness to provide mandatory blood specimens and biopsy tissue for correlative research\n* REGISTRATION: Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1\n* REGISTRATION: Histologically confirmed surgical diagnosis of epithelial ovarian, fallopian tube, carcinosarcoma, or primary peritoneal cancer with measurable disease. NOTE: Histologic confirmation of the primary tumor is required. Eligible histologies include serous, endometrioid, clear cell, mucinous, transitional cell, undifferentiated, or mixed carcinoma\n* REGISTRATION: MUC1 expression in ovarian cancer tumor cells verified by immunohistochemistry (IHC) in a Clinical Laboratory Improvement Act (CLIA) laboratory. Heterogeneous tumor expression of MUC1 is acceptable. MUC1 expression by staining score greater than 0 is deemed positive for this study\n* REGISTRATION: Expected survival unless investigational therapy is effective is greater than 6 months but less than 24 months\n* REGISTRATION: Willingness and ability to provide written informed consent\n* REGISTRATION: Willing to return to Mayo Clinic in Arizona (MCA) for follow-up during the active monitoring phase of the study\n* REGISTRATION: Willing to undergo leukapheresis for blood component collection\n* REGISTRATION: Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Lymphocyte count ≥ 1500\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Hemoglobin ≥ 8.0 g\u002FdL (performed ≤ 14 days prior to registration)\n* REGISTRATION: Platelet count ≥ 30,000\u002Fmm\\^3 (performed ≤ 14 days prior to registration)\n* REGISTRATION: Total bilirubin ≤ 2.0 mg\u002FdL unless patient has documented Gilbert's syndrome (subjects with Gilbert's syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) (performed ≤ 14 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate amino transferase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Prothrombin time (PT), international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulation therapy and INR or aPTT is within target range of therapy (for patients receiving anticoagulation, there should be no prior history of bleeding and no recent deep vein thrombosis \\[DVT\\]\u002Fpulmonary embolism \\[PE\\] ≤ 6 months prior to registration) (performed ≤ 14 days prior to registration)\n* REGISTRATION: Calculated creatinine clearance ≥ 30 ml\u002Fmin using the Cockcroft-Gault formula (performed ≤ 14 days prior to registration)\n* REGISTRATION: Baseline oxygen saturation ≥ 90% on room air\n* REGISTRATION: Negative urine or serological pregnancy test ≤ 7 days prior to registration\n\nExclusion Criteria:\n\n* Clinically unresolved central nervous system (CNS) metastases. NOTE: Patients with a prior history of brain metastases are allowed if focally treated, radiographically stable for \\> 30 days, and not requiring steroid therapy for \\> 14 days\n* Prior treatment targeting MUC1\n* Subjects with known plasma cell leukemia (PCL)\n* Any of the following are excluded because this study involves an agent (CTX) that has known genotoxic, mutagenic and\u002For teratogenic effects:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate birth control measures\n* History of myocardial infarction ≤ 6 months prior to registration, and\u002For congestive heart failure requiring ongoing treatment such as medications and\u002For an implanted defibrillator to control life-threatening arrhythmias\n* Failure to recover to grade 1 or baseline from acute, reversible effects of prior therapy regardless of interval since last treatment. EXCEPTION: Grade 2 peripheral (sensory) neuropathy that has been stable for at least 3 months since completion of prior treatment.\n* Uncontrolled concurrent illness including, but not limited to:\n\n  * Inability to clear an ongoing or active infection\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Uncontrolled psychiatric problems\n  * Inability to have a caregiver for active oversight during treatment period\n  * Dyspnea at rest due to complications of advanced malignancy or other disease that requires continuous oxygen therapy\n  * Any other conditions that the protocol investigators deem could potentially limit compliance with study requirements\n* Evidence of clinical immunocompromise and\u002For HIV positivity and currently receiving antiretroviral therapy\n* Patients requiring chronic supraphysiologic daily doses of steroids (\\> 10 mg prednisone or prednisolone, ≥ 4 mg Decadron or ≥ 50 mg hydrocortisol daily)\n* Patients receiving any other investigational agent which could be considered a treatment for the neoplasm\n* Other active malignancy first documented ≤ 4 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of other malignancy, the patient must not be receiving other treatment aimed at suppressing its recurrence\n* Diagnosis of autoimmune disease\n\n  * Known history of active autoimmune disease that has required systemic treatment in the ≤ 30 days (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) prior to pre-registration. NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Patients with vitiligo, Graves' disease, or psoriasis not requiring systemic treatment within the past 30 days are not excluded. Patients with Celiac disease controlled with diet modification are not excluded",{"count":65,"type":21},12,[24],"This phase I trial tests the safety, side effects, best dose of MUC1-activated T cells in treating patients with ovarian cancer that has come back after a period of improvement (relapsed) or that remains despite treatment (resistant). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and are made in a laboratory to recognize MUC1, a protein on the surface of tumor cells that plays a key role in tumor cell growth. These MUC1-activated T cells may help the body's immune system identify and kill MUC1 expressing ovarian tumor cells.",[69,70,71,30,72,73,34,35,74,75,39,43,76,77,78,79],"Platinum-Resistant Fallopian Tube Carcinoma","Platinum-Resistant Ovarian Carcinoma","Platinum-Resistant Primary Peritoneal Carcinoma","Recurrent Fallopian Tube Carcinosarcoma","Recurrent Female Reproductive System Carcinoma","Recurrent Platinum-Resistant Fallopian Tube Carcinoma","Recurrent Platinum-Resistant Ovarian Carcinoma","Refractory Fallopian Tube Carcinoma","Refractory Female Reproductive System Carcinoma","Refractory Ovarian Carcinoma","Refractory Primary Peritoneal Carcinoma","2026-03-13",{"date":82,"type":48},"2026-03-16",{"date":84,"type":48},"2024-09-20",{"date":86,"type":21},"2028-09-30",{"name":54,"class":55},1]