[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629507":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":35,"collaborators":37,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":25,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":25,"enrollmentInfo":49,"targetDuration":25,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":25,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"Alvotech Swiss AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AVT32-DRL_PB","EXPERIMENTAL","AVT32-DRL\\_PB will be administered during double blind period and open label period",[13],"Biological: AVT32-DRL_PB",{"label":15,"type":16,"description":17,"interventionNames":18},"Keytruda","ACTIVE_COMPARATOR","Keytruda will be administered during double blind period",[19],"Biological: Keytruda",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","AVT32-DRL\\_PB at a dose 200 mg administered intravenously every 3 weeks.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Keytruda at a dose 200 mg administered intravenously every 3 weeks.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Clinical Development Lead","CONTACT","+41 78 659 8989","alvotech.clinical@alvotech.com",{"type":36,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[38],{"name":39,"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","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":50,"type":51},120,"ESTIMATED","INTERVENTIONAL",[54],"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.",[57],"Melanoma","NOT_YET_RECRUITING","2026-03-11",{"date":61,"type":62},"2026-03-16","ACTUAL",{"date":64,"type":51},"2026-06-19",{"date":66,"type":51},"2028-04-14",{"name":5,"class":6}]