Neoadjuvant Combination Immunotherapy for Stage III Melanoma
Summary
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.
Detailed description
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.
Arms & interventions
- DrugPembrolizumab
Preoperative infusions
- DrugTalimogene Laherparepvec
Preoperative intralesional injection
Outcome measures
Primary
Pathologic Complete Response
Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection
Time frame: 6 months
Secondary
Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events
Time frame: Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years
Eligibility criteria
Study locations (1)
University of Louisville
Louisville, Kentucky, 40202