[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cancer-of-endometrium\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cancer-of-endometrium":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":48},"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",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":72,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100598533","phase-2-psilocybin-assisted-psychotherapy-in-cancer-patients-with-adjustment-disorder-100598533","NCT07072728","Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder","A Phase 2b Double-blind, Randomized, Low-dose Comparator-controlled Clinical Trial to Assess the Efficacy and Safety of NPX-5 in Psilocybin-assisted Psychotherapy for the Treatment of Adjustment Disorder Associated With Cancer.","Inclusion Criteria:\n\nTo be eligible for study entry participants must satisfy all of the following criteria:\n\n1. Screening AjD diagnosis (ICD-11), as defined by an ADNM-20 score ≥ 47.5, a score of ≥ 4 on the Distress Thermometer.\n2. Screening HAM-A Score ≥18 (moderate anxiety).\n3. Adults aged 18 to 80 years (inclusive) at screening.\n4. Diagnosed with cancer (exempting those cancers listed in the exclusion criteria) and a minimum life-expectancy of 6 months in the opinion of the treating physician, with performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale performed at screening.\n5. Agrees not to commence any new psychiatric medications or psychotherapies from Screening to Week 10.\n6. Able to communicate well and follow study procedures, judged as sufficiently competent with the English language by the investigator, able to build adequate rapport with study staff.\n7. Judged to be of low suicide risk based on Sheehan-Suicide Tracking Scale (S-STS) and the opinion of a research team psychiatrist.\n8. Be medically suitable in the opinion of the investigator as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and blood tests.\n9. Have access to a device that is compatible to use the digital technology, i.e smart-phone device or tablet.\n10. Agree not to take any sedating medications for a minimum of 12 hours before the dosing session including benzodiazepines, zopiclone, eszopiclone, zaleplon and zolpidem. Medications for cancer-related pain are permitted.\n11. Must be willing and able to refrain from smoking throughout the duration of the dosing session. Nicotine replacement therapies may be permitted with the agreement of the medical monitor.\n12. Agree that for 1 week before the psilocybin dosing session, participants will refrain from taking any illegal drugs or non-prescription medication (including cannabis, or CBD or THC containing products), nutritional supplement, or herbal supplement except when approved by the study investigators. Additionally, agree not to take any form of psilocybin outside of the study, including microdosing, from baseline through Day 70\u002FWeek 10 (Visit 11).\n13. Participants taking any other medication that is not explicitly detailed as an excluded medication will be discussed with the investigator and medical monitor as appropriate. Decisions on inclusion will be based on clinical judgement and with sufficient justification provided.\n\nExclusion Criteria\n\nParticipants will be excluded from the study if one or more of the following criteria are applicable:\n\nPsychiatric Exclusion Criteria:\n\n1. Current Major Depressive Disorder MDD (or within 12 months of Screening) deemed independent from the cancer diagnosis, current or past diagnosis of schizophrenia, psychotic disorder, unless this was resulting from a medical condition (e.g. lupus or malaria etc.), bipolar disorder I and II, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anti-social personality disorder or judged to be incompatible with establishment of rapport or safe exposure to psilocybin, as determined using clinical judgement of past and present medical and psychiatric history by any specialist psychiatrist or registered medical professional under the authorized delegation of a specialist psychiatrist.\n2. First-degree relative with a diagnosed psychotic disorder.\n3. Scores from the screening psychiatrist (or registered medical professional under the authorized delegation of a specialist psychiatrist) and baseline (S-STS) that indicate that the participant is of clinically significant risk of suicide. A decision will be formed based on S-STS scores and used in combination with other clinically significant data at screening. Sites should refer to the medical monitor if required.\n4. Has attempted suicide in the twelve months preceding the screening visit.\n5. Current (\\\u003C 1 year) alcohol or drug misuse as identified as moderate or severe during screening in accordance with Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, using the MINI 7.0.2, not able or willing to abstain from alcohol consumption in the period 12 hours prior to the dosing session.\n6. Any other reason that might prevent a participant from engaging in therapeutic preparation and integration sessions.\n7. Anyone who has taken a microdose of psilocybin within 5 days of baseline, taken a higher dose of psilocybin (e.g., dried mushrooms or capsules) within 30 days of baseline and experienced euphoria, hallucinations, or altered mental status, or used any classic psychedelics (LSD, ibogaine, ayahuasca, DMT, mescaline) within 3 months prior to baseline.\n\nMedical Exclusion Criteria:\n\n1. Diagnosed with brain metastases, glioblastoma, phaeochromocytoma, bowel obstruction or intestinal failure, active carcinoid syndrome, uncontrolled hypercalcaemia, or uncontrolled diabetes mellitus or insipidus.\n2. Currently taking or planning to take any of the following: any typical or atypical antipsychotic and monoamine-oxidase inhibitors. Participants with prior use of these medications must be willing to discontinue their use for at least 2 weeks prior to the baseline visit and to Day 28.\n3. Currently taking or planning to take any anticonvulsant or mood stabilizer, including carbamazepine, lithium, phenytoin, and valproate. Participants with prior use of these medications must be willing to discontinue their use for at least 1 week prior to the baseline visit and to Day 28.\n4. Any form of fungal allergy.\n5. Positive pregnancy test at screening, women who are breastfeeding or of childbearing potential who are unwilling or unable to use an effective form of contraception (or abstinence) for the study period and for 1 month post NPX-5 dose will be excluded. Women will be required to conduct a serum pregnancy test at the in-person screening visit and urine test prior to dosing session. Male participants who do not agree to use contraception for the study period and for 90 days post NPX-5 dose to mitigate the risk of pregnancy will also be excluded. Note: Refer to Section 4.3.2.1 for further details about contraception.\n6. A diagnosis of epilepsy or at significant risk of seizures based on medical history.\n7. Cardiovascular conditions including stroke and\u002For myocardial infarction (less than one year before providing informed consent), uncontrolled hypertension (blood pressure \\> 140\u002F90 mmHg) or clinically significant arrhythmia at screening. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n8. Anyone who, at screening, has clinically significant findings on physical examination, including resting vital signs (HR below 40 or above 120 bpm, blood pressure below 90\u002F60 or above 140\u002F90), ECG (QTcF \\> 450 msec for males and \\>470 for females), and positive alcohol breath test. Note: Inclusion of individuals with any out-of-range values, including blood pressure, is at the discretion of the Investigator.\n9. Liver dysfunction at screening as defined by AST and\u002For ALT \\> 1.5 times the upper level of normal or upper reference range. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to the administration of psilocybin, following discretion of the investigator.\n10. Renal Function: estimated glomerular filtration rate \\\u003C60 mL\u002Fmin (calculated using Chronic Kidney Disease Epidemiology Collaboration) unless this is a direct result of the cancer diagnosis and does not present a risk to the administration of psilocybin, following the discretion of the investigator.\n11. Any clinically significant laboratory abnormality(s) that in the opinion of the investigator would present a risk to the administration of psilocybin.\n12. Any clinically significant renal, pulmonary, gastrointestinal, hepatic, or other illness that could affect the interpretation of results or be a potential health risk for the person if they were to be included in the study. Results are exempt if they are a direct result of the participant's cancer diagnosis and do not present a risk to administration of psilocybin, following discretion of the investigator.\n13. Below 18 or above 32kg\u002Fm2 Body Mass Index (BMI) score at Screening.\n14. Anyone with organic brain injury or diagnosed with any cognitive impairment.\n15. Positive urine drug test for non-prescribed psychoactive substances at the dosing session visit. Positive urine drug test for psychoactive substances at the in-person screening should be referred to the medical monitor. Note: Testing may be repeated once at the discretion of the Investigator.\n16. Anyone on a research study of an investigational drug or who has been on a clinical trial within 3 months of enrolment.","80 Years",{"count":58,"type":20},87,[24],"This study is assessing the efficacy and safety of NPX-5 in psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to cancer diagnosis.\n\nWho is it for? This study is for people who are aged between 18 and 80 years old and suffer from anxiety after adjusting to an acutely stressful event of their cancer diagnosis. This is called adjustment disorder.\n\nStudy details Participants in this study will be randomly allocated by chance (similar to flipping a coin) to one of three groups: a 25mg NPX-5 dose group, a 10 mg NPX-5 dose group or a 1mg NPX-5 dose group. Participants will be allocated a dose that will be administered during their psilocybin-assisted psychotherapy (PAP) dosing session. The PAP dosing session will run approximately 8 hours, with NPX-5 administered at Day 14 (dosing day).\n\nAt Week 10, non-responders that continue to meet the study eligibility criteria may commence an additional PAP cycle (at 25 mg NPX-5). A maximum of 2 PAP cycles may be administered. Long term follow up will comprise of a study visit at 3 months post Week 10 (of the final cycle) to assess safety and tolerability of NPX-5.\n\nIt is hoped that this research will develop important scientific knowledge that could contribute to the development of a potential new treatment for anxiety and depression after adjusting to an acutely stressful event such as a cancer diagnosis.",[62,63,64,65,28,66,67,68,69,70,71],"Adjustment Disorder","Adjustment Disorder With Anxious Mood","Cancer","Cancer Cachexia","Cancer of Kidney","Cancer of Prostate","Cancer of the Breast","Cancer of Stomach","Cancer Melanoma Skin","Cancer Pancreas",[64,62,73,74,75],"Existential Distress","Psilocybin","Psilocin","2026-03-01",{"date":78,"type":40},"2026-03-03",{"date":80,"type":40},"2025-10-01",{"date":82,"type":20},"2027-07-30",{"name":84,"class":85},"Psyence Australia Pty Ltd","INDUSTRY",3]