University of Louisville
Determine safety and efficacy of pre-operative combination immunotherapy with Talimogene Laherparepvec (T-VEC)/Pembrolizumab 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.
Inclusion Criteria: * 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…
Preoperative infusions
Preoperative intralesional injection
Arctuva estimate
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