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- ||| Tavo (tavokinogene telsaplasmid) / OncoSec, CORVax12 / OncoSec
Biomarker, Trial termination: CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - Oct 28, 2024
P1, N=16, Terminated, Sponsor: 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.
- | Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Neoadjuvant intratumoral plasmid interleukin-12 electro-gene-transfer and nivolumab in patients with operable locoregionally advanced melanoma. (Pubmed Central) - Oct 17, 2024
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.
- | Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date: Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov) - May 31, 2024
P2, N=17, Active, not recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
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. Trial completion date: Jul 2025 --> Jun 2028 | Trial primary completion date: Jul 2023 --> Jun 2028
- | Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date: Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov) - May 8, 2024
P2, N=17, Active, not recruiting, Sponsor: 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: Feb 2025 --> Jul 2025 | Trial primary completion date: Feb 2025 --> Jul 2023
- Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / Ono Pharma, BMS
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 (Section 43) - Mar 5, 2024 - Abstract #AACR2024AACR_5133;
P2
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.
- | Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date: Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov) - Mar 5, 2024
P2, N=17, Active, not recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
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. Trial completion date: Feb 2024 --> Feb 2025 | Trial primary completion date: Feb 2024 --> Feb 2025
- | Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date: Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov) - Dec 5, 2023
P2, N=17, Active, not recruiting, Sponsor: 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: Nov 2023 --> Feb 2024 | Trial primary completion date: Nov 2023 --> Feb 2024
- Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / Ono Pharma, BMS
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 () - Jul 27, 2023 - Abstract #ESMO2023ESMO_2618;
P2
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.
- ||| Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
Enrollment closed, Enrollment change: Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov) - Jun 18, 2023
P2, N=17, Active, not recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enhanced immune activation in responding patients supports the proposed immune mechanisms. Recruiting --> Active, not recruiting | N=33 --> 17
- || Tavo (tavokinogene telsaplasmid) / OncoSec
Enrollment closed, Trial primary completion date, Metastases: KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov) - Jun 1, 2023
P2, N=65, Active, not recruiting, Sponsor: OncoSec Medical Incorporated
Recruiting --> Active, not recruiting | N=33 --> 17 Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Apr 2024
- || Tavo (tavokinogene telsaplasmid) / OncoSec
Enrollment closed, Trial completion date, Trial primary completion date: KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov) - Mar 27, 2023
P2, N=143, Active, not recruiting, Sponsor: OncoSec Medical Incorporated
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2023 --> Apr 2024 Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Mar 2023
- || Tavo (tavokinogene telsaplasmid) / OncoSec, CORVax12 / OncoSec
Biomarker, Trial completion, Enrollment change: CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - Jan 5, 2023
P1, N=16, Completed, Sponsor: Providence Health & Services
Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> Jul 2024 | Trial primary completion date: Dec 2023 --> Mar 2023 Active, not recruiting --> Completed | N=36 --> 16
- || Tavo (tavokinogene telsaplasmid) / OncoSec
Trial completion date, Trial primary completion date: KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov) - Dec 23, 2022
P2, N=143, Recruiting, Sponsor: OncoSec Medical Incorporated
Active, not recruiting --> Completed | N=36 --> 16 Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2023
- ||||| Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Combination therapy: LIVE from @sitcancer annual meeting! @MoffittNews @ATarhiniMDPhD discusses neoadjuvant intratumoral TAVO-EP in combination with nivolumab. #SITC22 (Twitter) - Nov 10, 2022
- ||||| Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / Ono Pharma, BMS
Biomarker, Clinical: Presenting LIVE @sitcancer #SITC2022 – #Neoadjuvant intratumoral TAVO-EP (plasmid #IL12 electro gene transfer) with #nivolumab; preliminary clinical & #biomarker data in patients with operable locoregionally advanced #melanoma @MoffittNews (Twitter) - Nov 10, 2022
- ||||| Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / Ono Pharma, BMS
Clinical, Combination therapy: Moffitt's @ATarhiniMDPhD presents on neoadjuvant intratumoral TAVO-EP (plasmid IL-12 electro gene transfer) in combination with nivolumab. Check out his poster today @sitcancer and look for abstract 617. #SITC22 (Twitter) - Nov 10, 2022
- |||| Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / Ono Pharma, BMS
Biomarker, Clinical, Combination therapy: @sitcancer #SITC2022 – Abstract 617 #Neoadjuvant intratumoral TAVO-EP (plasmid #IL12 electro gene transfer) in combination with #nivolumab; preliminary clinical & #biomarker data in operable locoregionally advanced #melanoma / @MoffittNews Team #Science https://t.co/m5mBcyHkTJ (Twitter) - Nov 8, 2022
- | Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
Trial completion date, Trial primary completion date: Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov) - Nov 4, 2022
P2, N=33, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Trial completion date: Jul 2023 --> Dec 2025 | Trial primary completion date: Dec 2022 --> Dec 2023 Trial completion date: Nov 2022 --> Nov 2023 | Trial primary completion date: Nov 2022 --> Nov 2023
- Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / Ono Pharma, BMS
Neoadjuvant intratumoral TAVO-EP (plasmid IL-12 electro gene transfer) in combination with nivolumab; preliminary clinical and biomarker data in patients with operable locoregionally advanced melanoma (Hall C) - Oct 6, 2022 - Abstract #SITC2022SITC_941;
P2
There was evidence of significantly enhanced immune activation supporting the proposed immune mechanisms. Analyses of additional biomaterials are underway.
- ||| Keytruda (pembrolizumab) / Merck (MSD), epacadostat (INCB024360) / Incyte
Trial completion date, Trial termination, Trial primary completion date: NCI-2018-02901: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat (clinicaltrials.gov) - Sep 6, 2022
P2, N=14, Terminated, Sponsor: Chase Heaton, MD
Analyses of additional biomaterials are underway. Trial completion date: May 2024 --> Jul 2022 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Jul 2022; Treatment Ineffective
- ||| Keytruda (pembrolizumab) / Merck (MSD), epacadostat (INCB024360) / Incyte
Enrollment closed, Enrollment change: NCI-2018-02901: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat (clinicaltrials.gov) - Jul 18, 2022
P2, N=14, Active, not recruiting, Sponsor: Chase Heaton, MD
Trial completion date: May 2024 --> Jul 2022 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Jul 2022; Treatment Ineffective Recruiting --> Active, not recruiting | N=96 --> 14
- | Tavo (tavokinogene telsaplasmid) / OncoSec
Journal, PD(L)-1 Biomarker, IO biomarker: Intratumoral electroporation of plasmid encoded IL-12 and membrane-anchored anti-CD3 increases systemic tumor immunity. (Pubmed Central) - Jun 8, 2022
Intratumoral delivery of plasmid IL12 via electroporation (IT-tavo-EP) induces localized expression of IL12 leading to regression of treated and distant tumors with durable responses and minimal toxicity...Moreover, combination of IL 12 and anti CD3 restored the function of TIL isolated from a melanoma patient actively progressing on PD 1 checkpoint inhibitor therapy. This DNA encodable polyclonal T cell stimulator (membrane anchored anti CD3 plasmid) may represent a key addition to intratumoral IL-12 therapies in the clinic.
- | Tavo (tavokinogene telsaplasmid) / OncoSec
Journal, PD(L)-1 Biomarker, IO biomarker: Amplification of the CXCR3/CXCL9 axis via intratumoral electroporation of plasmid CXCL9 synergizes with plasmid IL-12 therapy to elicit robust anti-tumor immunity. (Pubmed Central) - May 21, 2022
Collectively, these data demonstrate that a functional tumoral CXCR3/CXCL9 axis is critical for IL-12 anti-tumor efficacy. Furthermore, restoring or amplifying the CXCL9 gradient in the tumors via intratumoral electroporation of plasmid CXCL9 can not only result in efficient trafficking of cytotoxic CD8 T cells into the tumor but can also reshape the microenvironment to promote systemic immune response.
- ||| Keytruda (pembrolizumab) / Merck (MSD), epacadostat (INCB024360) / Incyte
Enrollment open, Enrollment change: NCI-2018-02901: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat (clinicaltrials.gov) - Apr 13, 2022
P2, N=96, Recruiting, Sponsor: Chase Heaton, MD
Furthermore, restoring or amplifying the CXCL9 gradient in the tumors via intratumoral electroporation of plasmid CXCL9 can not only result in efficient trafficking of cytotoxic CD8 T cells into the tumor but can also reshape the microenvironment to promote systemic immune response. Active, not recruiting --> Recruiting | N=14 --> 96
- CORVax12 / OncoSec
Evaluation of the long-term anti-Spike immune response following a novel coronavirus vaccine (CORVax): electroporation of SARS-CoV-2 Spike plasmid DNA plus IL12 plasmid DNA (Exhibit Hall; P1019) - Apr 8, 2022 - Abstract #IMMUNOLOGY2022IMMUNOLOGY_1402;
At one year following vaccination the anti-Spike IgG titers were higher in mice that received CORVax plus IL-12, however the rate at which the titers waned from their initial peak was comparable whether the mice received IL-12 or not. Additional studies are ongoing to determine whether the addition of IL-12 will enhance an anti-Spike memory response.
- || Tavo (tavokinogene telsaplasmid) / OncoSec
Clinical, Journal, Gene Signature, PD(L)-1 Biomarker, IO biomarker: Intratumoral plasmid IL-12 expands CD8+ T cells and induces a CXCR3 gene signature in triple-negative breast tumors that sensitizes patients to anti-PD-1 therapy. (Pubmed Central) - Mar 17, 2022
These data show a safe, effective intratumoral therapy that can enhance antigen presentation and recruit CD8 T cells, which are required for the anti-tumor efficacy. We identify a Tavo treatment-related gene signature associated with improved outcomes and conversion of non-responsive tumors, potentially even beyond TNBC.
- | Tavo (tavokinogene telsaplasmid) / OncoSec, CORVax12 / OncoSec
Biomarker, Trial completion date, Trial primary completion date: CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - Feb 2, 2022
P1, N=36, Active, not recruiting, Sponsor: Providence Health & Services
We identify a Tavo treatment-related gene signature associated with improved outcomes and conversion of non-responsive tumors, potentially even beyond TNBC. Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: Jul 2021 --> Jul 2022
- |||| Keytruda (pembrolizumab) / Merck (MSD), ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
P3 data: #ICYMI $ONCS/@OncoSec’s #TAVO + $MRK/@Merck’s #Keytruda in late stage #MetastaticMelanoma #Melanoma #Pivotal #Phase3 $MRK (or $BMY, $RHHBY/@genentech, $PFE, $AZN, $REGN, $GSK, $GILD, etc) should definitely acquire $ONCS $ADAP $IMCR $AFMD $CYCC $LPTX $PAVM $ONCT $INO $XBI $IBB (Twitter) - Nov 29, 2021
- ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
[VIRTUAL] Updated Clinical Data from KEYNOTE-695 (Virtual Meeting Platform) - Nov 18, 2021 - Abstract #SITC2021SITC_1343;
Trial completion date: May 2022 --> Dec 2022 | Trial primary completion date: Jul 2021 --> Jul 2022 Sponsored by OncoSec TAVO (IL-12) Intralesional Therapy Durable Responses in PD-1 Progressing Advanced Melanoma: Clinical Significance and Practicality of the Data
- ||||| Keytruda (pembrolizumab) / Merck (MSD), ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
On the other hand, OncoSec's TAVO-EP + Keytruda in PD-1 progressed #melanoma scores mOS close to 24mos. Abscopal effect of TAVO intriguing! #SITC21 #immunotherapy (Twitter) - Nov 12, 2021
- Keytruda (pembrolizumab) / Merck (MSD), ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
Durable responses with intratumoral electroporation of plasmid interleukin-12 plus pembrolizumab in patients with advanced triple-negative breast cancer: Cohort 1 update from KEYNOTE-890 (Hall 1) - Oct 26, 2021 - Abstract #SABCS2021SABCS_823;
P2
This novel immunotherapeutic regimen warrants further evaluation in 2L+ advanced TNBC. Cohort 2 exploring TAVO‑EP + pembrolizumab + chemotherapy in frontline TNBC is currently enrolling.
- Keytruda (pembrolizumab) / Merck (MSD), ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
Trial in progress: Phase 2 study of intratumoral plasmid interleukin-12 (tavokinogene telseplasmid; TAVO™) plus electroporation in combination with pembrolizumab with or without chemotherapy in patients with inoperable locally advanced or metastatic triple-negative breast cancer (KEYNOTE-890/OMS-I141) (Hall 1) - Oct 9, 2021 - Abstract #SABCS2021SABCS_372;
P2
Based on positive efficacy data in Cohort 1, additional cohorts are being planned and will be presented. ClinicalTrials.gov: NCT03567720
- |||| ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
FDA event: We contributed to the Phase 2 study of #tavo, and look forward to the next "phase" of this drug's progression towards possible #FDA approval https://t.co/r7N39sJKzW @Merck @OncoSec (Twitter) - Sep 16, 2021
- || Keytruda (pembrolizumab) / Merck (MSD), ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
P2 data, Journal: Phase II Trial of IL-12 Plasmid Transfection and PD-1 Blockade in Immunologically Quiescent Melanoma. (Pubmed Central) - Sep 15, 2021
No new or unexpected toxicities were observed. Correlative analysis showed T cell infiltration with enhanced immunity paralleling the clinical activity in low cpCTL tumors.
- ||| Keytruda (pembrolizumab) / Merck (MSD), epacadostat (INCB024360) / Incyte
Enrollment closed, Enrollment change: NCI-2018-02901: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat (clinicaltrials.gov) - Aug 9, 2021
P2, N=14, Active, not recruiting, Sponsor: Chase Heaton, MD
Correlative analysis showed T cell infiltration with enhanced immunity paralleling the clinical activity in low cpCTL tumors. Recruiting --> Active, not recruiting | N=68 --> 14
- || Keytruda (pembrolizumab) / Merck (MSD), epacadostat (INCB024360) / Incyte
Trial completion date, Trial primary completion date: NCI-2018-02901: Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat (clinicaltrials.gov) - Jun 11, 2021
P2, N=68, Recruiting, Sponsor: Chase Heaton, MD
Recruiting --> Active, not recruiting | N=68 --> 14 Trial completion date: Jan 2024 --> May 2024 | Trial primary completion date: Jan 2022 --> May 2024
- || Tavo (tavokinogene telsaplasmid) / OncoSec, CORVax12 / OncoSec
Biomarker, Enrollment closed: CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - Mar 15, 2021
P1, N=36, Active, not recruiting, Sponsor: Providence Health & Services
Trial completion date: Jan 2024 --> May 2024 | Trial primary completion date: Jan 2022 --> May 2024 Recruiting --> Active, not recruiting
- | Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
Trial initiation date: Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov) - Feb 3, 2021
P2, N=33, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Recruiting --> Active, not recruiting Initiation date: Aug 2020 --> Dec 2020
- || Tavo (tavokinogene telsaplasmid) / OncoSec, CORVax12 / OncoSec
Biomarker, Enrollment open: CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - Feb 1, 2021
P1, N=36, Recruiting, Sponsor: Providence Health & Services
Initiation date: Aug 2020 --> Dec 2020 Not yet recruiting --> Recruiting
- | ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
Journal, IO Biomarker: Intratumoral delivery of plasmid interleukin-12 via electroporation leads to regression of injected and non-injected tumors in Merkel cell carcinoma. (Pubmed Central) - Dec 18, 2020
Sustained local expression of IL-12 protein and local inflammation led to systemic immune responses and clinically meaningful benefit in some patients. Gene electrotransfer, specifically i.t.-tavo-EP, warrants further investigation for immunotherapy of cancer.
- || Tavo (tavokinogene telsaplasmid) / OncoSec, CORVax12 / OncoSec
Biomarker, New P1 trial: CORVax12: SARS-CoV-2 Spike (S) Protein Plasmid DNA Vaccine Trial for COVID-19 (SARS-CoV-2) (clinicaltrials.gov) - Nov 12, 2020
P1, N=36, Not yet recruiting, Sponsor: Providence Health & Services
- || Tavo (tavokinogene telsaplasmid) / OncoSec
Trial completion date, Trial primary completion date: KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov) - Oct 30, 2020
P2, N=125, Recruiting, Sponsor: OncoSec Medical Incorporated
Gene electrotransfer, specifically i.t.-tavo-EP, warrants further investigation for immunotherapy of cancer. Trial completion date: Dec 2021 --> Jul 2023 | Trial primary completion date: Dec 2020 --> Dec 2022
- ||| Tavo (tavokinogene telsaplasmid) / OncoSec
Enrollment open, Metastases: KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov) - Oct 26, 2020
P2, N=65, Recruiting, Sponsor: OncoSec Medical Incorporated
Trial completion date: Dec 2021 --> Jul 2023 | Trial primary completion date: Dec 2020 --> Dec 2022 Active, not recruiting --> Recruiting
- || Tavo (tavokinogene telsaplasmid) / OncoSec
Trial completion date, Trial primary completion date, Metastases: KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov) - Oct 1, 2020
P2, N=65, Active, not recruiting, Sponsor: OncoSec Medical Incorporated
Active, not recruiting --> Recruiting Trial completion date: Jan 2024 --> Aug 2024 | Trial primary completion date: Jul 2023 --> Dec 2023
- ||||| ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
Clinical: Excited to launch our latest investigator-initiated clinical & translational neoadjuvant trial in #melanoma: IT #IL12 plasmid (Tavo-EP) + #PD1 blockade. Designed to unleash #IL12 #cytokine effects in tumor + immune enhancing effect of blocking #PD1 https://t.co/2Nypnawvft (Twitter) - Aug 27, 2020
- || Tavo (tavokinogene telsaplasmid) / OncoSec, Opdivo (nivolumab) / BMS
New P2 trial: Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients (clinicaltrials.gov) - Aug 25, 2020
P2, N=33, Recruiting, Sponsor: H. Lee Moffitt Cancer Center and Research Institute
- | Tavo (tavokinogene telsaplasmid) / OncoSec
Trial completion date: KEYNOTE 695: Tavo and Pembrolizumab in Patients With Stage III/IV Melanoma Progressing on Either Pembrolizumab or Nivolumab Treatment (clinicaltrials.gov) - Aug 24, 2020
P2, N=100, Recruiting, Sponsor: OncoSec Medical Incorporated
Trial completion date: Jan 2024 --> Aug 2024 | Trial primary completion date: Jul 2023 --> Dec 2023 Trial completion date: Dec 2020 --> Dec 2021
- || Keytruda (pembrolizumab) / Merck (MSD), Tavo (tavokinogene telsaplasmid) / OncoSec
Trial completion, Metastases: Trial of pIL-12/MK-3475 in Metastatic Melanoma (clinicaltrials.gov) - Jun 17, 2020
P2, N=24, Completed, Sponsor: University of California, San Francisco
Trial completion date: Dec 2020 --> Dec 2021 Active, not recruiting --> Completed
- ||| Tavo (tavokinogene telsaplasmid) / OncoSec
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases: KEYNOTE-890: Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC (clinicaltrials.gov) - Jun 11, 2020
P2, N=65, Active, not recruiting, Sponsor: OncoSec Medical Incorporated
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=25 --> 65 | Trial completion date: Jan 2020 --> Jan 2024 | Trial primary completion date: Jan 2020 --> Jul 2023
- ImmunoPulse (tavokinogene telsaplasmid) / OncoSec
Intratumoral electroporation of plasmid-encoded IL-12 and membrane-bound anti-CD3 increases tumor immunogenicity and augments the function of T cell subsets (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2584;
Intratumoral (IT) delivery of plasmid IL-12 (tavokinogene telseplasmid; tavo) via electroporation (EP), collectively referred as IT-tavo-EP, generates immunologically-relevant levels of localized IL-12, triggering regression of both treated and distant tumors with minimal toxicity in preclinical and clinical studies...Moreover, functional restoration of TIL isolated from a melanoma patient with active clinical progression on anti-PD-1 therapy, was possible with engagement of membrane-bound αCD3 in the presence of IL-12. Collectively, these data continue to support the utility of IT-tavo-αCD3-EP as a promising therapeutic approach for patients with melanoma and other accessible solid tumors.