Cancer Type: Cutaneous
Study Type: Treatment
Phase: Phase II
Principal Investigator: Tarhini, Ahmad
Neoadjuvant Immunotherapy with Intratumoral Tavokinogene Telseplasmid (Tavo) plus Electroporation in Combination with Intravenous Nivolumab in Patients with Operable Locally- Regionally Advanced Melanoma
This study is designed to evaluate the safety and efficacy of neoadjuvant immunotherapy of intratumoral tavo-EP in combination with intravenous (IV) nivolumab followed by surgery and adjuvant phase with nivolumab monotherapy in subjects with operable, locally-regionally advanced melanoma
To assess the complete pCR of intratumoral tavo-EP in combination with IV nivolumab (collectively the combined treatment) in subjects with operable locally-regionally advanced melanoma. To assess : (a) radiologic/clinical preoperative response rate (b) RFS and (c) OS. To assess safety and tolerability of the combined treatment as neoadjuvant therapy in subjects with operable locally-regionally advanced melanoma.
BMS-936558 (Nivolumab); Nivolumab (Opdivo); Tavo-EP ()
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