[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629507":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":16,"studyPopulation":16,"armGroups":28,"interventions":41,"overallOfficials":16,"centralContacts":49,"locations":16,"responsibleParty":55,"collaborators":57,"id":60,"slug":16,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":16,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":16,"enrollmentInfo":68,"targetDuration":16,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":16,"overallStatus":77,"whyStopped":16,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":16},{"fullName":5,"class":6},"Alvotech Swiss AG","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"To demonstrate PK similarity of AVT32-DRL_PB versus Keytruda (pembrolizumab)","AUC0-3w (Cycle 1)","Cycle 1 (each cycle is 21 days)",{"measure":10,"description":14,"timeFrame":15},"AUCtau,ss (Cycle 6)","Cycle 6 (each cycle is 21 days)",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":16,"primaryPurpose":20,"observationalModel":16,"timePerspective":16,"maskingInfo":21},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":22,"maskingDescription":16,"whoMasked":23},"QUADRUPLE",[24,25,26,27],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[29,35],{"label":30,"type":31,"description":32,"interventionNames":33},"AVT32-DRL_PB","EXPERIMENTAL","AVT32-DRL\\_PB will be administered during double blind period and open label period",[34],"Biological: AVT32-DRL_PB",{"label":36,"type":37,"description":38,"interventionNames":39},"Keytruda","ACTIVE_COMPARATOR","Keytruda will be administered during double blind period",[40],"Biological: Keytruda",[42,46],{"type":43,"name":30,"description":44,"armGroupLabels":45,"otherNames":16},"BIOLOGICAL","AVT32-DRL\\_PB at a dose 200 mg administered intravenously every 3 weeks.",[30],{"type":43,"name":36,"description":47,"armGroupLabels":48,"otherNames":16},"Keytruda at a dose 200 mg administered intravenously every 3 weeks.",[36],[50],{"name":51,"role":52,"phone":53,"phoneExt":16,"email":54},"Clinical Development Lead","CONTACT","+41 78 659 8989","alvotech.clinical@alvotech.com",{"type":56,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[58],{"name":59,"class":6},"Dr. Reddy's Laboratories Limited","100629507",false,"NCT07475572","A Randomized, Double-Blind, Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Participants With Fully Resected Melanoma","A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants With Stage IIB\u002FC-III Melanoma Following Complete Resection","Inclusion Criteria:\n\n* Participants (male\u002Ffemale) ≥18 years of age at the time of signing the ICF.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at the time of enrollment.\n* Participants with Stage IIB, IIC, or III histologically confirmed cutaneous melanoma\n\nExclusion Criteria:\n\n* Have had a solid organ transplant or bone marrow (stem cell) transplant that used donor stem cells (allogenic).\n* Has received prior systemic anticancer therapy for melanoma including investigational agents.\n* Participants with a history of mucosal or uveal melanoma, even if diagnosis and treatment were completed \\>5 years ago.","ALL","18 Years",{"count":69,"type":70},120,"ESTIMATED","INTERVENTIONAL",[73],"PHASE1","This is a multicenter, randomized, double-blind, parallel-group, 2 treatment group, repeated dose study to compare the PK, efficacy, safety, and immunogenicity of AVT32-DRL\\_PB (proposed Keytruda® biosimilar) versus Keytruda (pembrolizumab) when administered as monotherapy in participants with fully resected Stage IIB\u002FC or Stage III melanoma requiring adjuvant treatment with pembrolizumab. Eligible participants will be randomized in a 1:1 ratio to the AVT32-DRL\\_PB or Keytruda treatment group and stratified by sex (female versus male) and body weight category (≤75 kg versus \\>75 kg). Study treatments will be administered every 3 weeks (Q3W) as an intravenous (IV) infusion over 30 minutes (1 administration Q3W is 1 treatment cycle). The administered pembrolizumab dose will be 200 mg Q3W for both treatment groups.",[76],"Melanoma","NOT_YET_RECRUITING","2026-03-11",{"date":80,"type":81},"2026-03-16","ACTUAL",{"date":83,"type":70},"2026-06-19",{"date":85,"type":70},"2028-04-14",{"name":5,"class":6}]