[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03842943":3,"trial-entities:NCT03842943":102,"trial-summary:NCT03842943":105},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":13,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":42,"secondary_outcomes":47,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":14,"eligibility_criteria":55,"std_ages":74,"locations":77,"central_contacts":92,"overall_officials":97,"references":100,"see_also_links":101},"NCT03842943","181095","Neoadjuvant Combination Immunotherapy for Stage III Melanoma","RECRUITING","2028-06-01","2024-04","2024-05-02","2019-07-03","University of Louisville","OTHER",false,"Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)\u002FPembrolizumab given prior to complete lymph node dissection in resectable stage 3 cutaneous melanoma with clinically apparent lymph node metastases.","This is a single arm Phase 2 study of pre-operative combination immunotherapy with pembrolizumab and T-VEC given for 6 months prior to complete lymph node dissection for stage 3 resectable cutaneous melanoma with clinically apparent lymph node metastases.",[18],"Cutaneous Melanoma",[],"INTERVENTIONAL",[22],"PHASE2",{"count":24,"type":25},28,"ESTIMATED",[27,35],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"DRUG","Pembrolizumab","Preoperative infusions",[32],"Combination T-VEC\u002FPembrolizumab",[34],"Keytruda",{"type":28,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Talimogene Laherparepvec","Preoperative intralesional injection",[32],[40,41],"T-VEC","Imlygic",[43],{"measure":44,"description":45,"timeFrame":46},"Pathologic Complete Response","Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection","6 months",[48],{"measure":49,"description":50,"timeFrame":51},"Safety and Tolerability of Preoperative T-VEC\u002Fpembrolizumab: Adverse events and Serious Adverse Events","Adverse events and Serious Adverse Events will be collected","Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years","ALL","18 Years",null,{"inclusion":56,"exclusion":66,"raw_text":73},[57,58,59,60,61,62,63,64,65],"18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma","ECOG performance status of 0 or 1","Adequate hematologic, hepatic, renal and coagulation function","Must have measurable disease and have an injectable target lymph node for intralesional therapy administration","Primary melanoma has been resected","Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist.","Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.","BRAF mutant or wild type allowed (mutations status not necessary for enrollment)","Signed, written informed consent",[67,68,69,70,71,72],"Cannot have metastatic (AJCC M1) disease","No primary mucosal or uveal melanoma","No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years","May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor","Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma\u002Fatopy, or evidence of clinically significant immunosuppression","Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use","Inclusion Criteria:\n\n* 18 years of age, any race or sex, who have pathologically confirmed cutaneous melanoma\n* ECOG performance status of 0 or 1\n* Adequate hematologic, hepatic, renal and coagulation function\n* Must have measurable disease and have an injectable target lymph node for intralesional therapy administration\n* Primary melanoma has been resected\n* Pathologically confirmed resectable stage III disease, clinically apparent. Resectability is at the discretion of the treating surgeon who is a melanoma specialist.\n* Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.\n* BRAF mutant or wild type allowed (mutations status not necessary for enrollment)\n* Signed, written informed consent\n\nExclusion Criteria:\n\n* Cannot have metastatic (AJCC M1) disease\n* No primary mucosal or uveal melanoma\n* No evidence of melanoma associated with immunodeficiency state or history or other malignancies (other than non-melanoma skin cancer) within the past 3 years\n* May not have been previously treated with T-VEC, any other oncolytic virus, pembrolizumab, or any other PD-1, PD-L1, or PD-L2 inhibitor\n* Must not have a history or evidence of symptomatic autoimmune pneumonitis, glomerulonephritis, vasculitis, or other symptomatic autoimmune disease, document history of autoimmune disease or syndrome requiring systemic treatment in the past two years (i.e. use of disease modifying agents, steroids, or immunosuppressive agents) except vitiligo or resolved childhood asthma\u002Fatopy, or evidence of clinically significant immunosuppression\n* Must not have active herpetic skin lesions or prior complications of herpetic infection and must not require intermittent or chronic treatment with an anti-herpetic drug (e.g. acyclovir) other than intermittent topical use",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":12,"status":7,"city":79,"state":80,"zip":81,"country":82,"contacts":83,"geoPoint":89},"Louisville","Kentucky","40202","United States",[84],{"name":85,"role":86,"phone":87,"email":88},"Stacy Baum","CONTACT","502-562-4370","mary.baum@louisville.edu",{"lat":90,"lon":91},38.25424,-85.75941,[93],{"name":94,"role":86,"phone":95,"email":96},"Michael Egger, MD","502-629-6950","michael.egger@louisville.edu",[98],{"name":94,"affiliation":12,"role":99},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":103,"biomarkers":104},[18],[],{"nct_id":4,"found":106,"summary":107,"prompt_version":117},true,{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is a single-arm Phase 2 study, meaning all 28 participants will receive the same treatment. It is designed to evaluate the safety and effectiveness of the combined therapy.","completed","Combination Immunotherapy for Stage III Melanoma","This study is testing a combination of two immunotherapy drugs, Pembrolizumab and Talimogene Laherparepvec (T-VEC), before surgery for people with stage III melanoma that has spread to the lymph nodes. Immunotherapy helps your body's immune system fight cancer. Researchers want to see how safe and effective this combination is. You might be able to join if you are 18 or older, have stage III melanoma that can be removed by surgery, and meet other health requirements. The main goal is to see if the treatment completely removes the cancer before surgery, which will be checked at 6 months. The current status of this study is unclear, and it plans to enroll 28 participants.","The primary outcome, pathologic complete response, is measured at 6 months after treatment.",113,"You would receive Pembrolizumab infusions and T-VEC injections before having surgery to remove lymph nodes. This treatment would be given for 6 months.","Not stated in the trial record.",[29,36],"v2"]