[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carcinoma-of-endometrium\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carcinoma-of-endometrium":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100535566","phase-1-pembrolizumab-lenvatinib-and-il-15-superagonist-n-803-in-combination-with-her2-targeting-autologous-dendritic-cell-adher2dc-vaccine-in-participants-with-advanced-or-metastatic-endometrial-cancer-100535566",false,"NCT06253494","Pembrolizumab, Lenvatinib and IL-15 Superagonist N-803 in Combination With HER2 Targeting Autologous Dendritic Cell (AdHER2DC) Vaccine in Participants With Advanced or Metastatic Endometrial Cancer","* INCLUSION CRITERIA:\n* Histologically confirmed endometrial cancer.\n* Radiographically confirmed metastatic or locally advanced disease.\n* Evaluable (measurable or non-measurable) disease, per RECIST 1.1.\n* HER2 IHC 1+, 2+ or 3+ tumor confirmed by PATHWAY HER2 (4B5) test. NOTE: The HER2 status in participants who had prior anti-HER2 therapy should be confirmed in the tumor tissue obtained after completing the anti-HER2 therapy.\n* Participants must have received and progressed after at least one (1) line of systemic therapy for endometrial cancer.\n* Age \\>=18 years.\n* ECOG performance status \\\u003C=2.\n* Participants must have available tumor tissue or be willing to undergo a mandatory research biopsy. NOTE: Samples must be collected after HER2 directed therapy if the participant had anti-HER2 therapy.\n* Participants must have adequate organ and marrow function as defined below:\n\n  * Absolute neutrophil count (ANC) \\> 1,000\u002Fmicroliter\n  * Platelets \\> 100,000\u002Fmicroliter\n  * Hemoglobin (Hgb) \\> 9 g\u002FdL (any number of transfusions within 60 days before apheresis is allowed)\n  * Total bilirubin \\\u003C=1.5 X upper limit of normal (ULN). NOTE: In participants with Gilbert s Syndrome or known liver metastasis, total bilirubin \\\u003C=3.0 X ULN is allowed\n  * Aspartate aminotransferase (AST) \u002F Alanine aminotransferase (ALT) \\\u003C=3.0 X ULN. NOTE: AST\u002FALT \\\u003C=5.0 X ULN is allowed in participants with known liver metastasis\n  * An estimated creatinine clearance (CrCl) \\\u003C=1.5 X ULN OR \\>30 mL\u002Fmin\u002F1.73 m2 for participants with creatinine levels \\>1.5 X ULN (calculated creatinine clearance (CrCl) (eGFR may also be used in place of CrCl)\n  * Dip stick urine protein \\\u003C 3 or urine protein \\\u003C 1 gram (g)\u002F24 hour if dip stick urine is \\>= 3+\n* Hepatitis B virus (HBV)-infected participants can be enrolled if HBV DNA is undetectable. Hepatitis C virus (HCV)-infected participants can be enrolled if HCV RNA level is undetectable.\n* Participants with previously treated non-active brain metastases or central nervous system metastases more than 28 days from definitive radiotherapy or surgery are eligible.\n* Individuals of child-bearing potential (IOCBP) must agree to use highly effective contraception (hormonal, intrauterine device (IUD), tube ligation, a partner has had the previous vasectomy, abstinence) at the time of study entry, for the duration of study treatment, and up to 6 months after the last dose of the study drug(s).\n* Nursing participants must be willing to discontinue nursing from study treatment initiation through 6 months after the last dose of the study drug(s).\n* Participants must be able to understand and be willing to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\n* Administration of any standard of care or investigational checkpoint inhibitors (e.g., anti-CTLA, anti-PD-1, anti-PD-L1, anti-TIGIT, anti-TIM3, or anti-LAG3 antibodies or small molecules) within 6 months prior to apheresis.\n* History of grade 3 or 4 immune related adverse events from the use of immune checkpoint inhibitors.\n* History of Lenvatinib use\n* History of severe immediate hypersensitivity reaction to compounds similar to study drugs or their components (e.g., monoclonal antibody preparations).\n* Surgery to abdomen\u002Fpelvis\u002Fchest within 3 months prior to apheresis.\n* Other malignancies diagnosed within 24 months prior to apheresis. NOTE: Participants who completed treatment for in-situ carcinomas (e.g., breast, cervix, bladder), or basal or squamous cell carcinoma of the skin are eligible if no ongoing treatment is needed per Standard of Care.\n* Arterial or venous thromboembolism within 6 months prior to apheresis.\n* History of cerebrovascular accident or stroke (transient ischemic attack, hemorrhagic or ischemic) within 6 months prior to apheresis.\n* Functional or objective cardiac dysfunction: New York Heart Association (NYHA) Functional Capacity III or IV or Objective Assessment C or D.\n* Fridericia's corrected QT interval (QTcF) \\>= 480 msec or evidence of third-degree AV block on screening electrocardiogram (ECG).\n* Ejection fraction by screening echocardiogram \\\u003C 50 percent.\n* Participants requiring therapeutic anticoagulation regimen(s) (e.g., warfarin, rivaroxaban, apixaban, dabigatran, edoxaban, low molecular weight heparin \\[e.g., enoxaparin, dalteparin, tinzaparin\\], heparin, fondaparinux).\n* History of gastrointestinal or non-gastrointestinal fistula \\>= Grade 3 (CTCAE v.5.0).\n* Radiographic evidence of major blood vessel invasion\u002Finfiltration.\n* History of hemoptysis or tumor bleeding within 1 month prior to apheresis.\n* Current gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.\n* Any form of primary immunodeficiency.\n* Participants with active autoimmune disease or a history of autoimmune disease, which require immune suppressive treatment such as systemic corticosteroids or other systemic immune suppressants (e.g., methotrexate, cyclosporine, and biologics). NOTE: Participants with vitiligo, endocrine deficiencies on replacement dose are eligible.\n* Systemic corticosteroid therapy of higher than a physiologic dose (the equivalent of prednisone 10 mg\u002Fday) within 14 days prior to apheresis. NOTE: Any topical steroid medications (e.g., corticosteroid creams, ointments, and eye drops) are allowed.\n* Solid organ or allogeneic hematopoietic stem cell transplant recipients.\n* Human immunodeficiency virus (HIV)-positive participants.\n* Pregnancy (confirmed with beta-Human chorionic gonadotropin (HCG) serum or urine pregnancy test performed in IOCBP at screening).\n* Uncontrolled intercurrent illness or situation that would limit compliance with study requirements.","ALL","18 Years","120 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Background:\n\nEndometrial cancer (EC) of the uterus is becoming more common in the US. Sometimes EC often has increased levels of a protein called HER2. Cancers with HER2 tend to be more aggressive and have poorer outcomes.\n\nObjective:\n\nTo test 2 study drugs-a vaccine that targets HER2 (AdHER2DC) plus a drug that supercharges immune cells that kill tumor cells (N-803)-combined with 2 FDA-approved cancer treatment drugs in people with EC.\n\nEligibility:\n\nAdults aged 18 and older with HER2-positive EC that returned or got worse after treatment.\n\nDesign:\n\nAdHER2DC vaccine is made from each participant s own blood. Participants will undergo apheresis: Blood is removed from the body through a tube attached to a needle. The blood passes through a machine that separates out the target cells. The remaining blood is returned to the body through a second needle. A special catheter may be needed.\n\nThe first treatment cycle is 28 days; each cycle after that will be 21 days.\n\nAll participants will get the 2 approved drugs and the vaccine. One drug is a tablet taken by mouth once a day, every day. The other drug is given through a tube attached to a needle inserted into a vein.\n\nThe vaccine is injected under the skin. Participants will receive the vaccine on day 1 of cycles 1, 2, and 3. Additional doses up to 3 doses will be give if possible.\n\nSome participants will receive N-803. This drug is injected under the skin of the abdomen on day 1 of each cycle.\n\nTreatment may last up to 1 year. Follow-up visits will continue up to 2 more years.",[27,28,29,30],"Endometrial Cancer","Cancer of Endometrium","Carcinoma of Endometrium","Endometrial Carcinoma",[32,33,34,35],"Cancer Vaccine","Combination of anti-cancer drugs","Immunotherapy","HER2 Positive Cancer","RECRUITING","2026-04-08",{"date":39,"type":40},"2026-04-09","ACTUAL",{"date":42,"type":40},"2024-05-14",{"date":44,"type":20},"2028-12-31",{"name":46,"class":47},"National Cancer Institute (NCI)","NIH"]