[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535566":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":47,"centralContacts":52,"locations":61,"responsibleParty":81,"collaborators":28,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":28,"eligibilityCriteria":88,"healthyVolunteers":85,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":28,"studyType":95,"phases":96,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":64,"whyStopped":28,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1","EXPERIMENTAL","AdHER2DC vaccine + pembrolizumab + de-escalating doses of lenvatinib",[13,14,15,16],"Biological: AdHER2DC vaccine","Biological: Pembrolizumab","Drug: Lenvatinib","Device: PATHWAY HER2 (4B5) assay",{"label":18,"type":10,"description":19,"interventionNames":20},"Arm 2","AdHER2DC vaccine + N-803 + pembrolizumab + RP2D of lenvatinib",[13,14,21,15,16],"Biological: N-803",[23,29,33,37,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","AdHER2DC vaccine","AdHER2DC vaccine is given by intradermal injections on Day 1 of cycles 1-3 (priming) followed by optional boost doses (up to 3), on Day 1 of cycles 6, 9, 12",[9,18],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Pembrolizumab","Pembrolizumab is given by IV infusion on Day 8 of cycle 1 and Day 1 of cycles 2-16",[9,18],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"N-803","N-803 is given by subcutaneous injections on Day 1 of cycles 1-16",[18],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"DRUG","Lenvatinib","Lenvatinib is taken orally on Days 8-28 on cycle 1 and every day of cycles 2-16",[9,18],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":28},"DEVICE","PATHWAY HER2 (4B5) assay","Used during screening to estimate eligibility",[9,18],[48],{"name":49,"affiliation":50,"role":51},"Hoyoung M Maeng, M.D.","National Cancer Institute (NCI)","PRINCIPAL_INVESTIGATOR",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":28,"email":57},"Megan P Hausler, R.N.","CONTACT","(240) 858-3544","megan.hausler@nih.gov",{"name":49,"role":55,"phone":59,"phoneExt":28,"email":60},"(240) 781-3253","hoyoung.maeng@nih.gov",[62],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-77.10026,38.98067,{"lat":74,"lon":73},[77],{"name":78,"role":55,"phone":79,"phoneExt":28,"email":80},"National Cancer Institute Referral Office","888-624-1937","NCIMO_Referrals@mail.nih.gov",{"type":82,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","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":93,"type":94},60,"ESTIMATED","INTERVENTIONAL",[97,98],"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.",[101,102,103,104],"Endometrial Cancer","Cancer of Endometrium","Carcinoma of Endometrium","Endometrial Carcinoma",[106,107,108,109],"Cancer Vaccine","Combination of anti-cancer drugs","Immunotherapy","HER2 Positive Cancer","2026-04-08",{"date":112,"type":113},"2026-04-09","ACTUAL",{"date":115,"type":113},"2024-05-14",{"date":117,"type":94},"2028-12-31",{"name":50,"class":6},1]