[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-fallopian-tube-endometrioid-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-fallopian-tube-endometrioid-adenocarcinoma":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":5},"100457017","phase-2-pembrolizumab-combined-with-bevacizumab-with-or-without-agonist-anti-cd40-cdx-1140-for-the-treatment-of-patients-with-recurrent-ovarian-cancer-100457017",false,"NCT05231122","Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 for the Treatment of Patients With Recurrent Ovarian Cancer","Randomized Phase 2 Clinical Trial of Pembrolizumab Combined With Bevacizumab With or Without Agonist Anti-CD40 CDX-1140 in Patients With Recurrent Ovarian Cancer","Inclusion Criteria:\n\n* Age \\>= 18 years of age.\n* Recurrent serous (low grade or high grade), endometrioid, or clear cell recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.\n* Participant can be either platinum-sensitive or platinum-resistant, no more than 4 prior lines of treatment, and BRCA status must be known.\n\nNeoadjuvant + adjuvant is considered one line.\n\n* Participants may have received a prior PARPi, this will not be considered a separate line of therapy if received in maintenance.\n* Participants may have received a prior anti-PD1\u002Fanti-PDL1 therapy or bevacizumab, these will not be considered a separate line of therapy.\n* Any chemotherapy regimen change due to toxicity in the absence of disease progression will be considered part of the same line of therapy.\n* Hormonal therapy for OC (e.g. Tamoxifen, aromatase inhibitors etc.) will not count as a separate line of prior therapy.\n\n  * Anticipated lifespan greater than 6 months.\n  * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n  * Patient has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria present.\n  * All residual toxicity related to prior anti-cancer therapies (excluding alopecia, grade 2 fatigue, vitiligo, endocrinopathies on stable replacement therapy, grade 2 neuropathy from taxanes or platinum and grade 2 hearing loss from platinum) must be resolved to grade 1 severity or less (or returned to baseline) prior to receipt of study treatment.\n  * Absolute neutrophil count (ANC): \\>= 1,500 \u002FmcL.\n  * Platelets: \\>= 100,000 \u002F mcL.\n  * Hemoglobin: \\>= 8 g\u002FdL or 5.0 mmol\u002FL transfusion allowed with adequate bone marrow function\n  * Creatinine clearance \\>= 50 mL\u002Fmin.\n  * Total bilirubin: =\\\u003C 2 X upper limit of normal (ULN) except patients with Gilbert's syndrome or liver involvement, who must have a total bilirubin =\\\u003C 3 mg\u002FdL.\n  * Aspartate aminotransferase (AST) ( serum glutamic-oxaloacetic transaminase \\[SGOT\\] ) and alanine aminotransferase (ALT) ( serum glutamate pyruvate transaminase \\[SGPT\\]): =\\\u003C 2.5 X ULN OR =\\\u003C 5 X ULN for participants with liver metastases.\n  * Albumin: \\> 2.5 mg\u002FdL.\n  * International normalized ratio (INR) OR prothrombin time (PT) 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  * Participant must be willing to undergo core or excisional biopsy of a tumor lesion within 7 days prior to the first dose of investigational product and after 3 cycles of treatment(prior to cycle 4-day 1: mandatory only if available) and, at the end of treatment (optional). Participants for whom newly obtained samples cannot be provided at baseline (e.g., inaccessible or subject safety concern), may submit an archived specimen, only upon agreement from the Prinicipal Investigator, if available).\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 6 months 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  * Participant (or legal representative) 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* Primary platinum-refractory patients are excluded\n* Has a nonepithelial cancer (germ cell tumors, sex cord-stromal tumors), borderline tumors, mucinous or seromucinous that is predominately mucinous, malignant Brenner's tumor, carcinosarcoma or undifferentiated carcinoma.\n* Receipt of any antibody targeting T cell checkpoint or co-stimulation pathways within 4 weeks, use of any other monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks prior to the planned start of study treatment.\n* Has received prior systemic anticancer therapy (including investigational agents or maintenance therapy) within 28 days prior to the planned start of study treatment.\n\nHormonal therapy is allowed until the time of randomization\n\n* Progression on prior immune checkpoint blockade therapy.\n* Systemic radiation therapy within 4 weeks, prior focal radiotherapy within 2 weeks prior to the first dose of study treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug\n* Major surgery within 4 weeks prior to the first dose of study treatment. Surgery requiring local\u002Fepidural anesthesia must be completed at least 72 hours before study drug administration and patients should be recovered.\n* Known or prior malignancy requiring active treatment in the past 2 years. Exception: basal or squamous cell skin cancer or in situ cancers; or any other cancer from which the patient has been disease-free for at least 3 years.\n* Active, untreated central nervous system metastases. Patients with brain metastases identified at screening may be rescreened after the lesion(s) have been appropriately treated; patients with treated brain metastases should be neurologically stable for 4 weeks post-treatment and prior to study enrollment, and off corticosteroids for at least 2 weeks before administration of study drugs, and treated lesions should demonstrate no new growth on the re-screening scan.\n* History of (non-infectious) pneumonitis or has current pneumonitis, including grade 1 (asymptomatic; clinical or diagnostic observations only; intervention not indicated) pneumonitis.\n* History of severe hypersensitivity reactions to other monoclonal antibodies (mAbs).\n* Prior therapy with any anti-CD40 antibody.\n* Hypersensitivity to bevacizumab, pembrolizumab, or any of its excipients.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)\n* Known active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months.\n* Has an acute infection requiring systemic therapy\n* Known immunodeficiency or active human immunodeficiency virus (HIV)\n* Concurrent active Hepatitis B (defined as HBsAg positive and\u002For detectable HBV DNA)and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Note: Hepatitis B and C screening tests are not required unless known history of HBV and HCV infection\n* Has an active infection requiring systemic therapy\n* Known immunodeficiency or active HIV\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 mRNA vaccines, adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy.\n\nInvestigational vaccines (i.e., those not licensed or approved for Emergency Use) are not allowed.\n\n* Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.\n* Subject requires or is likely to require more than a two-week course of corticosteroids for intercurrent illness. Subject must complete the course of corticosteroids 2 weeks before screening to meet eligibility.\n* Subject has a serious, non-healing wound, ulcer, or bone fracture.\n* Subject has a clinically significant cardiovascular disease including:\n\n  * Uncontrolled hypertension \\\u003C 150\u002F90 mmHg (may be rescreened after adequate control)\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* New onset on thromboembolic event or hemorrhage within 6 weeks prior to randomization\n* Subject has organ allografts.\n* Subject has clinical symptoms or signs of partial or complete gastrointestinal obstruction or require parenteral hydration and\u002For nutrition.\n* Pregnant or nursing female participants.\n* Known active alcohol or drug abuse.\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.","FEMALE","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests whether pembrolizumab combined with bevacizumab with or without agonist anti-CD40 CDX-1140 works to shrink tumors in patients with ovarian cancer that has come back (recurrent). Anti-CD40 CDX-1140 works by stimulating certain immune cells within the tumor and, when combined with other immunotherapy treatments, may increase antitumor antibody production. Immunotherapy with monoclonal antibodies, such as pembrolizumab and bevacizumab, may help the body's immune system, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab and bevacizumab with anti-CD40 CDX-1140 may decrease symptoms, prolong survival, and improve quality of life in patients with ovarian cancer.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"Ovarian Clear Cell Adenocarcinoma","Platinum-Sensitive Ovarian Carcinoma","Recurrent Endometrial Serous Adenocarcinoma","Recurrent Fallopian Tube Carcinoma","Recurrent Fallopian Tube Endometrioid Adenocarcinoma","Recurrent Fallopian Tube Serous Adenocarcinoma","Recurrent Ovarian Carcinoma","Recurrent Ovarian Clear Cell Adenocarcinoma","Recurrent Ovarian Endometrioid Adenocarcinoma","Recurrent Ovarian Serous Adenocarcinoma","Recurrent Platinum-Resistant Ovarian Carcinoma","Recurrent Primary Peritoneal Carcinoma","Recurrent Primary Peritoneal Clear Cell Adenocarcinoma","Recurrent Primary Peritoneal Endometrioid Adenocarcinoma","Recurrent Primary Peritoneal Serous Adenocarcinoma","RECRUITING","2026-05-28",{"date":44,"type":45},"2026-06-01","ACTUAL",{"date":47,"type":45},"2024-03-12",{"date":49,"type":20},"2027-03-15",{"name":51,"class":52},"Roswell Park Cancer Institute","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":21,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100510004","phase-1-vaccine-therapy-plus-pembrolizumab-in-treating-advanced-ovarian-fallopian-tube-or-primary-peritoneal-cavity-cancer-100510004","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",{"count":62,"type":20},40,[64,23],"PHASE1","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.",[67,68,29,69,30,70,32,71,33,34,72,37,38,39,73,74],"Fallopian Tube Carcinosarcoma","Primary Peritoneal Carcinosarcoma","Recurrent Fallopian Tube Clear Cell Adenocarcinoma","Recurrent Fallopian Tube High Grade Serous Adenocarcinoma","Recurrent Ovarian Carcinosarcoma","Recurrent Ovarian High Grade Serous Adenocarcinoma","Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma","Recurrent Primary Peritoneal Carcinosarcoma","2026-03-31",{"date":77,"type":45},"2026-04-06",{"date":79,"type":45},"2023-09-28",{"date":81,"type":20},"2028-06-30",{"name":83,"class":52},"Mayo Clinic",3]