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Clinical Trial 20313
Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT04526730
Phase: Phase II
Prinicipal Investigator: Ahmad Tarhini
Study Title
Neoadjuvant Immunotherapy with Intratumoral Tavokinogene Telseplasmid (Tavo) plus Electroporation in Combination with Intravenous Nivolumab in Patients with Operable Locally- Regionally Advanced Melanoma
Summary
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
Objective
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.
Therapies
Medications
BMS-936558 (Nivolumab); Nivolumab (Opdivo); Tavo-EP ()
Inclusion Criteria:
Exclusion Criteria:
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