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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
28
Preoperative infusions
Preoperative intralesional injection
University of Louisville
Louisville, Kentucky, United States
RECRUITINGPathologic Complete Response
Pathologic response rate in the regional nodal basin assessed after complete lymph node dissection
Time frame: 6 months
Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events
Adverse events and Serious Adverse Events will be collected
Time frame: Every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.