[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567544":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":53,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":21,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Chicago","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment arm","EXPERIMENTAL","Treatment consists of lenvatinib (20 mg orally once daily) in combination with pembrolizumab (200 mg IV every 3 weeks).\n\nPembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.",[13,14],"Drug: Pembrolizumab","Drug: Lenvatinib",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Pembrolizumab","Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.\n\nPembrolizumab will be given for a maximum of 2 years (total 35 cycles) with dosing every 3 weeks.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Lenvatinib","Lenvatinib will be taken once daily, with or without food, at the same time each day.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Clinical Trials Intake","CONTACT","8557028222","cancerclinicaltrials@bsd.uchicago.edu",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University of Chicago Medicine Comprehensive Cancer Center","RECRUITING","Chicago","Illinois","60637","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-87.65005,41.85003,{"lat":45,"lon":44},[48,50],{"name":28,"role":29,"phone":49,"phoneExt":21,"email":31},"1-855-702-8222",{"name":51,"role":52,"phone":21,"phoneExt":21,"email":21},"Manik Amin","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100567544","phase-2-lenvatinib-and-pembrolizumab-to-treat-patients-with-anal-or-rectum-cancer-that-has-gotten-worse-after-initial-treatment-100567544",false,"NCT06669572","Lenvatinib and Pembrolizumab to Treat Patients With Anal or Rectum Cancer That Has Gotten Worse After Initial Treatment","A Phase II, Multi-center, Single Arm Trial of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Locally Advanced and\u002For Metastatic Anorectal Squamous Cell Carcinoma (ASCC) After Progression on First Line Chemotherapy.","Inclusion Criteria:\n\n* Histological confirmation of anorectal squamous cell carcinoma per the American Joint Committee on Cancer 8th edition. NOTE: If archived tissue is not available for diagnostic histological confirmation \\[core, incisional, or excisional\\], a new biopsy of a tumor lesion prior to tumor irradiation should be obtained.\n* Unresectable locally advanced or metastatic anorectal squamous cell carcinoma following progression on first line chemotherapy or chemoradiation therapy. Prior use of immunotherapy with Retifanlimab is allowed but not mandatory.\n* Prior chemoradiation therapy with either definitive intent or palliative intent is allowed.\n* Measurable disease based on Response Evaluation Criteria In Solid Tumors 1.1 Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions within 28 days prior to registration.\n\nExclusion Criteria:\n\n* Has received prior therapy with an anti-PD-1, anti- PDL1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (eg, CTLA-4, OX-40, CD137) with the exception of Retifanlimab immunotherapy.\n* Prior significant immunotherapy related adverse events requiring permanent discontinuation of the immunotherapy agents including events like pneumonitis, myocarditis, renal failure, Guillain Barre syndrome or myasthenia gravis.\n* Active autoimmune disease with ongoing treatment with chronic immunosuppressive therapy such as DMARDs .","ALL","18 Years",{"count":65,"type":66},35,"ESTIMATED","INTERVENTIONAL",[69],"PHASE2","The purpose of this study is to gather information on the safety and effectiveness of lenvatinib combined with pembrolizumab in anal\u002Frectal cancer that has spread to other parts of the body and will not respond to standard care.",[72,73],"Carcinoma, Squamous Cell","Anorectal Cancer",[75,76,23,18],"chemotherapy","anorectal cancer","2026-04-13",{"date":79,"type":80},"2026-04-15","ACTUAL",{"date":82,"type":80},"2025-07-11",{"date":84,"type":66},"2029-03-26",{"name":5,"class":6},1]