drugset / Trial / NCT04526730
Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients
Phase 2
Completed
17 enrolled
H. Lee Moffitt Cancer Center and Research Institute
OncoSec Medical Incorporated · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma.
Timeline
- Start
- 2020-12-22
- Primary completion
- 2024-03-26
- Completion
- 2025-05-22
Publications
- Results Tarhini AA, Eroglu Z, Eljilany I, Zager JS, Gonzalez RJ, Sarnaik AA, Cruse CW, Khushalani NI, De Aquino DB, Abraham E, Acevedo DM, Richards A, Schell MJ, Kalos D, Chen PL, Messina JL, Canton DA, Sondak VK. Neoadjuvant Intratumoral Plasmid IL-12 Electro-Gene-Transfer and Nivolumab in Patients with Operable, Locoregionally Advanced Melanoma. Clin Cancer Res. 2024 Dec 2;30(23):5333-5341. doi: 10.1158/1078-0432.CCR-24-2768.
- Jacobs L, Yshii L, Junius S, Geukens N, Liston A, Hollevoet K, Declerck P. Intratumoral DNA-based delivery of checkpoint-inhibiting antibodies and interleukin 12 triggers T cell infiltration and anti-tumor response. Cancer Gene Ther. 2022 Jul;29(7):984-992. doi: 10.1038/s41417-021-00403-8. Epub 2021 Nov 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Tavokinogene Telseplasmid | Vaccine | 0.1 ml | Intrathecal |