[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659795":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":36,"interventions":48,"overallOfficials":58,"centralContacts":62,"locations":71,"responsibleParty":146,"collaborators":26,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":26,"enrollmentInfo":157,"targetDuration":26,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":170,"overallStatus":173,"whyStopped":26,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":183},{"fullName":5,"class":6},"UNC Lineberger Comprehensive Cancer Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Progression Free Survival","Progression Free Survival (PFS) is defined as the time from the date of randomization (at 1 year) to the first occurrence of disease progression (per RECIST 1.1 or comparable criteria) or death from any cause, whichever occurs first. Patients alive and progression-free at the end of study will be censored","Up to 36 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Immune-Related Adverse Events (irAEs)","Immune-related adverse events (irAEs) are defined as adverse events considered by the investigator to be immune-mediated (e.g., colitis, pneumonitis, and dermatitis) and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The incidence of irAEs will be summarized by treatment arm.",{"measure":18,"description":19,"timeFrame":12},"Immune-Related Adverse Events (irAEs) Grade 3 or higher","Immune-related adverse events (irAEs) are defined as adverse events considered by the investigator to be immune-mediated (e.g., colitis, pneumonitis, and dermatitis) and will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The incidence of Grade ≥3 irAEs between the 1-year and 2-year treatment-duration arms will be summarized by treatment arm.",{"measure":21,"description":22,"timeFrame":12},"Overall Survival (OS)","Overall survival (OS) is defined as the time from randomization to death from any cause. Participants who are alive at the time of analysis or lost to follow-up will be censored at the date they were last known to be alive.",{"measure":24,"description":25,"timeFrame":12},"Disease-Specific Survival (DSS)","Disease-Specific Survival (DSS) is defined as time from randomization to death specifically attributed to endometrial cancer.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":26,"timePerspective":26,"maskingInfo":32},"RANDOMIZED","PARALLEL","Pragmatic non-inferiority randomized controlled hybrid decentralized trial","TREATMENT",{"masking":33,"maskingDescription":26,"whoMasked":34},"SINGLE",[35],"PARTICIPANT",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"anti-PD1 maintenance therapy -1 year","EXPERIMENTAL","Participants receive one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).",[42],"Drug: anti-PD1 agent therapy - 1 year",{"label":44,"type":39,"description":45,"interventionNames":46},"anti-PD1 maintenance therapy - 2 years","Participants receive two years of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab).",[47],"Drug: anti-PD1 agent therapy - 2 years",[49,54],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":26},"DRUG","anti-PD1 agent therapy - 1 year","One year anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy",[38],{"type":50,"name":55,"description":56,"armGroupLabels":57,"otherNames":26},"anti-PD1 agent therapy - 2 years","Two years anti-PD-1 maintenance immunotherapy following completion of standard cytotoxic chemotherapy plus anti-PD-1 therapy",[44],[59],{"name":60,"affiliation":5,"role":61},"Olivia D Lara, MD, MS","PRINCIPAL_INVESTIGATOR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":26,"email":67},"Emmie Cole","CONTACT","919-984-0000","emmie_cole@med.unc.edu",{"name":69,"role":65,"phone":26,"phoneExt":26,"email":70},"Erin Jennings","Erin_jennings@med.unc.edu",[72,90,98,110,125,137],{"facility":73,"status":26,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"UNC Health Cancer Care, A Service of UNC Hospitals","Cary","North Carolina","27518","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-78.78112,35.79154,{"lat":83,"lon":82},[86,88],{"name":64,"role":65,"phone":87,"phoneExt":26,"email":67},"919-962-7327",{"name":89,"role":61,"phone":26,"phoneExt":26,"email":26},"Olivia D Lara, MD",{"facility":5,"status":26,"city":91,"state":75,"zip":92,"country":77,"countryCode":78,"cosmosGeoPoint":93,"geoPoint":97,"contacts":26},"Chapel Hill","27599",{"type":80,"coordinates":94},[95,96],-79.05584,35.9132,{"lat":96,"lon":95},{"facility":99,"status":26,"city":100,"state":75,"zip":101,"country":77,"countryCode":78,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"UNC Health Cancer Care, a service of UNC Hospitals (Garner)","Garner","27529",{"type":80,"coordinates":103},[104,105],-78.61417,35.71126,{"lat":105,"lon":104},[108,109],{"name":64,"role":65,"phone":87,"phoneExt":26,"email":67},{"name":89,"role":61,"phone":26,"phoneExt":26,"email":26},{"facility":111,"status":26,"city":112,"state":75,"zip":113,"country":77,"countryCode":78,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Wesley Long Cone Health Cancer Center","Greensboro","27403",{"type":80,"coordinates":115},[116,117],-79.79198,36.07264,{"lat":117,"lon":116},[120,123],{"name":121,"role":65,"phone":122,"phoneExt":26,"email":26},"Glenn P Boyles","336-832-1100",{"name":124,"role":61,"phone":26,"phoneExt":26,"email":26},"Glenn Boyles",{"facility":126,"status":26,"city":127,"state":75,"zip":128,"country":77,"countryCode":78,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"UNC Health Cancer Care, a service of UNC Hospitals (Raleigh)","Raleigh","27607",{"type":80,"coordinates":130},[131,132],-78.63861,35.7721,{"lat":132,"lon":131},[135,136],{"name":64,"role":65,"phone":87,"phoneExt":26,"email":67},{"name":89,"role":61,"phone":26,"phoneExt":26,"email":26},{"facility":138,"status":26,"city":127,"state":75,"zip":139,"country":77,"countryCode":78,"cosmosGeoPoint":140,"geoPoint":142,"contacts":143},"UNC Health Cancer Care, a service of UNC Hospitals (Wakefield)","27614",{"type":80,"coordinates":141},[131,132],{"lat":132,"lon":131},[144,145],{"name":64,"role":65,"phone":87,"phoneExt":26,"email":67},{"name":89,"role":61,"phone":26,"phoneExt":26,"email":26},{"type":147,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100659795","phase-3-assessing-survival-outcomes-with-checkpoint-inhibition-extended-vs-discontinued-in-endometrial-cancer-100659795",false,"NCT07867002","Assessing Survival Outcomes With Checkpoint Inhibition ExteNded vs Discontinued in Endometrial Cancer","ASCEND-EC-DCT","Inclusion Criteria:\n\nIn order to participate in this study a subject must meet ALL of the eligibility criteria outlined below.\n\nWritten informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subject is willing and able to comply with study procedures based on the judgement of the investigator.\n\n* Age ≥ 18 years at the time of consent.\n* Advanced stage (FIGO Stage III or IV) or recurrent EC.\n* Histological or cytological evidence\u002Fconfirmation of any EC subtype, including carcinosarcoma.\n* Subject has completed standard of care carboplatin\u002Ftaxol\u002Fanti-PD1 therapy (pembrolizumab or dostarlimab) with the plan for maintenance anti-PD-1 therapy.\n\nExclusion Criteria:\n\n* Tumors with unknown mismatch repair protein status.\n* Receipt of additional anti-cancer agent(s) (e.g. bevacizumab, lenvatinib, progestins), other than cytotoxic chemotherapy received in combination with a PD-1 inhibitor at the beginning of the index treatment period (maintenance period).","ALL","18 Years",{"count":158,"type":159},140,"ESTIMATED","INTERVENTIONAL",[162],"PHASE3","This is a pragmatic, non-inferiority randomized hybrid decentralized clinical trial. The goal of this study is to determine if one year of maintenance immunotherapy (anti-PD1 agent therapy; pembrolizumab or dostarlimab) is non-inferior to two years of maintenance therapy for patients with advanced\u002Fmetastatic or recurrent endometrial cancer who have completed the standard course of cytotoxic chemotherapy plus anti-PD1 therapy (chemoimmunotherapy). Our hypothesis is that one year of maintenance therapy will be comparable, or statistically non-inferior, to two years of therapy. This question has clinical importance as there is not a clear optimal duration for maintenance immunotherapy in this setting, and checkpoint inhibitors are associated with their own unique toxicity profile (immune-related adverse events) and incremental costs to patients and the healthcare system at large. Patients who respond favorably to primary therapy and choose to enroll will be randomized (1:1) after completion of chemoimmunotherapy to one-year of maintenance anti-PD1 therapy (1-year arm) or to two-years of maintenance anti-PD1 therapy (2-year arm). The primary endpoint is progression-free survival (PFS) determined over the course of at least 3 years from randomization of patient follow up. Secondary endpoints are overall survival (OS) and incidence of immune-related adverse events (irAE). Finally, exploratory objectives include measuring differences in gut and vaginal microbial profiles and innate immune system (IIS) tumor profiles and correlation with clinical outcomes (PFS, OS).",[165,166,167,168,169],"Endometrial Adenocarcinoma","Metastatic Endometrial Cancer","Endometrial Cancer","Recurrent Endometrial Cancer","Relapse Endometrial Cancer",[171,172],"immunotherapy","maintenance immunotherapy","NOT_YET_RECRUITING","2026-10-04",{"date":176,"type":177},"2026-10-09","ACTUAL",{"date":179,"type":159},"2026-10",{"date":181,"type":159},"2032-10",{"name":5,"class":6},6]