[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614190":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":48,"centralContacts":52,"locations":57,"responsibleParty":102,"collaborators":47,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":47,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":47,"enrollmentInfo":113,"targetDuration":47,"studyType":116,"phases":117,"briefSummary":120,"conditions":121,"keywords":123,"overallStatus":60,"whyStopped":47,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Corcept Therapeutics","INDUSTRY",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1a: Nenocorilant 200 mg and Nivolumab","EXPERIMENTAL","Cohort 1a: Patients will receive nenocorilant 200 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.",[13,14],"Drug: Nenocorilant 200 mg","Drug: Nivolumab",{"label":16,"type":10,"description":17,"interventionNames":18},"Cohort 1b: Nenocorilant 300 mg and Nivolumab","Cohort 1b: Patients will receive nenocorilant 300 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.",[19,14],"Drug: Nenocorilant 300 mg",{"label":21,"type":10,"description":22,"interventionNames":23},"Cohort 1c: Nenocorilant 400 mg and Nivolumab","Cohort 1c: Patients will receive nenocorilant 400 mg orally under fed conditions once daily, and nivolumab 240 mg IV every 2 weeks. After 3 months of treatment, patients may choose to switch the nivolumab regimen to 480 mg IV every 4 weeks if the nenocorilant nivolumab combination is tolerated.",[24,14],"Drug: Nenocorilant 400 mg",[26,33,38,43],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Nenocorilant 200 mg","Nenocorilant 200 mg will be supplied as 50 and\u002For 100 mg tablets.",[9],[32],"CORT125236",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"Nenocorilant 300 mg","Nenocorilant 300 mg will be supplied as 50 and\u002For 100 mg tablets.",[16],[32],{"type":27,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Nenocorilant 400 mg","Nenocorilant 400 mg will be supplied as 50 and\u002For 100 mg tablets.",[21],[32],{"type":27,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Nivolumab","Nivolumab 240 mg and 480 mg will be supplied as single-dose 120 mg\u002F12 mL (10 mg\u002FmL) vials.",[9,16,21],null,[49],{"name":50,"affiliation":5,"role":51},"Camille Renard","STUDY_DIRECTOR",[53],{"name":5,"role":54,"phone":55,"phoneExt":47,"email":56},"CONTACT","(669) 251-7034","corceptstudy750@corcept.com",[58,72,82,92],{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":47},"Site 03","RECRUITING","Los Angeles","California","90025","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-118.24368,34.05223,{"lat":70,"lon":69},{"facility":73,"status":60,"city":74,"state":75,"zip":76,"country":64,"countryCode":65,"cosmosGeoPoint":77,"geoPoint":81,"contacts":47},"Site 04","Grand Rapids","Michigan","49546",{"type":67,"coordinates":78},[79,80],-85.66809,42.96336,{"lat":80,"lon":79},{"facility":83,"status":60,"city":84,"state":85,"zip":86,"country":64,"countryCode":65,"cosmosGeoPoint":87,"geoPoint":91,"contacts":47},"Site 01","San Antonio","Texas","78229",{"type":67,"coordinates":88},[89,90],-98.49363,29.42412,{"lat":90,"lon":89},{"facility":93,"status":60,"city":94,"state":95,"zip":96,"country":64,"countryCode":65,"cosmosGeoPoint":97,"geoPoint":101,"contacts":47},"Site 02","West Valley City","Utah","84119",{"type":67,"coordinates":98},[99,100],-112.00105,40.69161,{"lat":100,"lon":99},{"type":103,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100614190","phase-1-two-part-study-of-nenocorilant-combined-with-nivolumab-in-patients-with-advanced-solid-malignancies-100614190",false,"NCT07276373","Two Part Study of Nenocorilant Combined With Nivolumab in Patients With Advanced Solid Malignancies","A Phase 1b\u002F2, Open-Label, Dose-Finding and Proof of Concept Study of Nenocorilant in Combination With Anti-Programmed Cell Death\u002F(Ligand) 1 in Patients With Advanced Solid Malignancies","Inclusion Criteria:\n\nPart 1\n\n* Signed and dated institutional review board (IRB)\u002F independent ethics committee (IEC)-approved informed consent form (ICF)\n* Has solid malignancies that have received all available standard therapies for the specific tumor type or for which no standard therapy exists, unless patient is intolerant of treatment\n* Has a life expectancy of ≥ 3 months\n* Has evaluable disease based on RECIST v1.1\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Has adequate organ function\n* Negative serum or urine pregnancy test for female patients of childbearing potential\n* Agreement to use appropriate precautions to avoid pregnancy, unless the patient and\u002For their sole sexual partner is permanently sterilized\n\nExclusion Criteria:\n\nPart 1\n\n* Past or current immune-related adverse events (irAEs) due to anti-programmed cell death protein 1 ligand 1 (PD\\[L\\]1) therapy that meet any of the following criteria:\n\n  1. Grade ≥ 3\n  2. Resulted in discontinuation of anti-PD(L)1 therapy\n* Medical history of an autoimmune or inflammatory disease requiring immunosuppressive therapy\n* Medical history of adrenal insufficiency\n* Has had any major surgery within 4 weeks prior to the first dose of study treatment\n* Concurrent treatment with mifepristone or another glucocorticoid receptor (GR) modulator\n* Unable to swallow, retain, or absorb oral medication\n* Concurrent participation in another interventional clinical trial\n* Has toxicities due to prior therapies that are reversible and have not resolved\n* Requirement for treatment with prohibited medications, including but not limited to systemic corticosteroids and cytochrome P450(CYP)3A inducers or inhibitors\n* Has a known history of severe hypersensitivity to any of the study drugs, or other human\u002Fhumanized monoclonal antibodies\n* Pregnant or lactating patients or female patients expecting to conceive children within the projected duration of the trial\n* Has clinically significant uncontrolled condition(s) which, in the opinion of the Investigator, may confound the results of the trial or interfere with the patient's safety or participation\n* Known psychiatric disorder that would interfere with trial compliance\n* Has infection with HIV, hepatitis C virus, or hepatitis B virus\n* Has untreated parenchymal brain metastasis or has uncontrolled central nervous system metastases\n* Has a history of another malignancy within 2 years prior to study treatment, unless cured\n* Has received prior autologous or allogeneic organ or tissue transplantation\n* A QTcF interval \\>450 msec, a family history of long QT syndrome or unexplained sudden death at young age, or a requirement for use of medication that may prolong the QTc interval","ALL","18 Years",{"count":114,"type":115},50,"ESTIMATED","INTERVENTIONAL",[118,119],"PHASE1","PHASE2","This open-label, dose-finding, and proof of concept study will evaluate the safety, tolerability, maximum-tolerated dose (MTD) and\u002For optimal dose of nenocorilant when administered in combination with nivolumab in patients with advanced solid malignancies.",[122],"Neoplasms",[124,125,126],"Advanced Solid Tumors","Solid Tumors","Solid Malignancies","2026-06-26",{"date":129,"type":130},"2026-06-30","ACTUAL",{"date":132,"type":130},"2026-01-16",{"date":134,"type":115},"2027-01",{"name":5,"class":6},4]