[{"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":55,"responsibleParty":68,"collaborators":70,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":16,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":16,"enrollmentInfo":82,"targetDuration":16,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":16,"overallStatus":58,"whyStopped":16,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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",[56],{"facility":57,"status":58,"city":59,"state":16,"zip":16,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":16},"Site number 07010","RECRUITING","Kiev","Ukraine","UA",{"type":63,"coordinates":64},"Point",[65,66],30.5238,50.45466,{"lat":66,"lon":65},{"type":69,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR",[71],{"name":72,"class":6},"Dr. Reddy's Laboratories Limited","100629507","phase-1-a-randomized-double-blind-pharmacokinetic-similarity-study-to-compare-avt32-drlpb-with-keytruda-in-participants-with-fully-resected-melanoma-100629507",false,"NCT07475572","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":83,"type":84},120,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90],"Melanoma","2026-08-21",{"date":93,"type":94},"2026-08-24","ACTUAL",{"date":96,"type":94},"2026-08-10",{"date":98,"type":84},"2028-04-14",{"name":5,"class":6},1]