^
    1year
    CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov)
    P1, N=16, Terminated, Providence Health & Services | Completed --> Terminated; Study was ended prematurely due to lack of efficacy. As per FDA guidance, our site continued to follow enrolled subjects through the 180 day safety visit.
    Trial termination
    |
    Tavo (tavokinogene telsaplasmid)
    1year
    Neoadjuvant intratumoral plasmid interleukin-12 electro-gene-transfer and nivolumab in patients with operable locoregionally advanced melanoma. (PubMed, Clin Cancer Res)
    The clinical efficacy of neoadjuvant IT TAVO-EP + nivolumab is promising with 80% of patients achieving an MPR. Evidence of potent immune activation both systemically and within the TME along with a favorable safety profile supports the activity of local IL-12 and anti-PD1 based regimens.
    Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    PD-L1 expression • CD8 expression • IFNG expression
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    over1year
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jul 2025 --> Jun 2028 | Trial primary completion date: Jul 2023 --> Jun 2028
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    over1year
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Feb 2025 --> Jul 2025 | Trial primary completion date: Feb 2025 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    almost2years
    Tumoral and systemic immune modulation with neoadjuvant (NeoAd) intratumoral (IT) TAVO-EP (plasmid IL-12 electro gene transfer) and nivolumab (NIVO) in patients (pts) with operable locoregionally advanced melanoma (AACR 2024)
    At baseline, most patients exhibited low CD8+ TIL, PD-L1 and TIS, with enhanced immune activation following treatment in the TME and blood including increased immune-related gene expression, CD8+ TIL, peritumoral CD8+ T cells and TIS. Four of 5 pts with negative predictive baseline biomarkers [CD8+TIL/PD-L1/TIS]low experienced pCRs supporting activity of IL12/anti-PD1 based regimens in this setting.
    Clinical • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma) • JAK1 (Janus Kinase 1) • IL2 (Interleukin 2)
    |
    CD8 expression
    |
    PD-L1 IHC 22C3 pharmDx • nCounter® PanCancer IO 360™ Panel
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    almost2years
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    2years
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Nov 2023 --> Feb 2024 | Trial primary completion date: Nov 2023 --> Feb 2024
    Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    over2years
    Neoadjuvant (NeoAd) intratumoral (IT) TAVO-EP (plasmid IL-12 electro gene transfer) in combination with nivolumab (NIVO) for patients (pts) with operable locoregionally advanced melanoma (ESMO 2023)
    Conclusions NeoAd IT TAVO-EP and iv NIVO exhibited promising clinical activity and a favorable safety profile. Enhanced immune activation in responding patients supports the proposed immune mechanisms.
    Clinical • Combination therapy • PD(L)-1 Biomarker • IO biomarker • Metastases
    |
    PD-L1 (Programmed death ligand 1) • CD8 (cluster of differentiation 8) • IFNG (Interferon, gamma)
    |
    CD8 expression
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    over2years
    Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Recruiting --> Active, not recruiting | N=33 --> 17
    Enrollment closed • Enrollment change • Combination therapy • Metastases
    |
    LDH elevation
    |
    Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    over2years
    KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov)
    P2; Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Apr 2024
    Combination therapy • Trial primary completion date • Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • PD-L1 (Programmed death ligand 1) • ER (Estrogen receptor)
    |
    PD-L1 negative
    |
    PD-L1 IHC 22C3 pharmDx
    |
    Keytruda (pembrolizumab) • carboplatin • gemcitabine • albumin-bound paclitaxel • Tavo (tavokinogene telsaplasmid)
    over2years
    KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov)
    P2, N=143, Active, not recruiting, OncoSec Medical Incorporated | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Mar 2023
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)
    almost3years
    KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov)
    P2, N=143, Recruiting, OncoSec Medical Incorporated | Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2023
    Trial completion date • Trial primary completion date
    |
    BRAF (B-raf proto-oncogene)
    |
    BRAF mutation • BRAF V600
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tavo (tavokinogene telsaplasmid)