[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636407":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":21,"responsibleParty":32,"collaborators":21,"id":34,"slug":35,"hasResults":36,"nctId":37,"briefTitle":38,"officialTitle":39,"acronym":40,"eligibilityCriteria":41,"healthyVolunteers":36,"sex":42,"minAge":43,"maxAge":21,"enrollmentInfo":44,"targetDuration":21,"studyType":47,"phases":48,"briefSummary":50,"conditions":51,"keywords":21,"overallStatus":53,"whyStopped":21,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":21},{"fullName":5,"class":6},"Primmune Therapeutics, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoadjuvant PRTX007 + Pembrolizumab (Response-Adapted Adjuvant Therapy)","EXPERIMENTAL","Participants with resectable Stage III melanoma will receive neoadjuvant treatment with PRTX007 in combination with pembrolizumab prior to definitive surgical resection. Following surgery, participants will receive response-adapted adjuvant therapy based on pathologic response. Participants achieving a major pathologic response (MPR) may receive observation or pembrolizumab alone, while participants without MPR will receive adjuvant PRTX007 in combination with pembrolizumab.",[13,14],"Drug: PRTX007","Drug: Pembrolizumab",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","PRTX007","PRTX007 is an orally administered prodrug of PRX034, a Toll-like receptor 7 (TLR7) agonist designed to activate innate and adaptive immune responses.\n\nNEOADJUVANT REGIMEN\n\n* 600 mg orally once daily (safety run-in participants) or\n* 750 mg orally once daily (subsequent participants)\n* Administered 3 days on, 4 days off (7-day cycle)\n* Total of 9 cycles (9 weeks)\n\nADJUVANT REGIMEN (IF NO MPR)\n\n* 750 mg orally once daily\n* Administered 3 days on, 4 days off\n* Total of 12 cycles (12 weeks)",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Pembrolizumab","Pembrolizumab is a programmed cell death protein-1 (PD-1) blocking antibody administered by intravenous infusion\n\nNEOADJUVANT REGIMEN\n\n* 200 mg IV every 3 weeks (Q3W)\n* Total of 3 cycles (9 weeks)\n\nADJUVANT REGIMEN\n\n* 400 mg IV every 6 weeks (Q6W) for 7 cycles OR\n* 200 mg IV every 3 weeks (Q3W) for 14 cycles\n* Total duration: approximately 42 weeks",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Gunjan Mody","CONTACT","+61 2 9199 9596","gunjan.mody@novotech-cro.com",{"type":33,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100636407","phase-2-the-efficacy-and-safety-of-prtx007-003-combined-with-pembrolizumab-in-resectable-stage-iii-melanoma-100636407",false,"NCT07565285","The Efficacy and Safety of PRTX007-003 Combined With Pembrolizumab in Resectable Stage III Melanoma","A Phase 2 Study to Investigate the Activity of Neoadjuvant PRTX007 Combined With Pembrolizumab in Participants With Stage III Melanoma (INFLECTION-003)","INFLECTION-003","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Histologically confirmed, resectable Stage III cutaneous melanoma.\n* Candidate for curative-intent surgical resection\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate organ function\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Prior systemic therapy for melanoma, including immunotherapy\n* Uveal melanoma or mucosal melanoma.\n* Active autoimmune disease requiring systemic treatment\n* Primary immunodeficiency or use of systemic immunosuppressive therapy\n* Women who are pregnant or breastfeeding\n* Recent treatment with another investigational therapy\n* Any condition that, in the opinion of the investigator, would interfere with study participation or safety","ALL","18 Years",{"count":45,"type":46},48,"ESTIMATED","INTERVENTIONAL",[49],"PHASE2","This Phase 2, multi-center, single-arm study evaluates the safety, tolerability, and activity of neoadjuvant PRTX007 in combination with pembrolizumab in participants with resectable Stage III melanoma. Neoadjuvant immunotherapy has demonstrated improved clinical outcomes compared with adjuvant-only approaches, but there remains a need to enhance pathologic response rates without significant added toxicity.\n\nParticipants will receive oral PRTX007, a Toll-like receptor 7 (TLR7) agonist prodrug, administered in combination with intravenous pembrolizumab prior to surgical resection. The primary objective is to determine the major pathologic response (MPR) rate following neoadjuvant therapy. Secondary objectives include evaluation of safety, pathologic complete response, event-free survival, overall survival, pharmacokinetics, and immune-related biomarkers.\n\nThis study aims to determine whether the addition of PRTX007 to pembrolizumab improves antitumor immune responses and clinical outcomes in patients with Stage III melanoma.",[52],"Melanoma Stage III","NOT_YET_RECRUITING","2026-06-18",{"date":56,"type":57},"2026-06-23","ACTUAL",{"date":59,"type":46},"2026-07-01",{"date":61,"type":46},"2029-06",{"name":5,"class":6}]