This is a Phase 2, Multi-Cohort, Open-Label, Multi-Center Study. Cohort 1 will be a single-arm study of intratumoral tavokinogene telseplasmid (TAVO) plus electroporation (EP) in combination with pembrolizumab therapy. Cohort 2 will be a single-arm study of intratumoral TAVO-EP plus pembrolizumab along with treatment of an approved chemotherapy per standard of care (either nab-paclitaxel (Abraxane®) or gemcitabine (Gemzar®) plus carboplatin (Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or metastatic setting will be enrolled in this study.
The study will include a screening period, treatment period (up to 2 years), a long-term follow-up period, and a survival follow-up period. Participants will be followed for disease status and survival for up to a total duration of 5 years from the time of first dose of study treatment. Eligible subjects with accessible lesions will be treated with TAVO-EP on Days 1, 5 and 8 every 6 weeks for up to 18 weeks. Pembrolizumab IV will be administered at a dose of 200 mg on Day 1 every 3-weeks for up to 35 cycles (Q3W) or 400 mg on Day 1 every 6 weeks for up to 18 cycles (Q6W). Eligible subjects will be enrolled in one of the following cohorts. * Cohort 1 is a single-arm study of intratumoral TAVO-EP and pembrolizumab (Q3W) in participants with TNBC and at least 1 line of prior systemic therapy in the advanced or metastatic setting. * Cohort 2 is a single-arm study of intratumoral TAVO-EP and pembrolizumab along with treatment with an approved chemotherapy per standard of care (either nab-paclitaxel (Abraxane®)or gemcitabine (Gemzar®) plus carboplatin (Paraplatin®)) in participants with TNBC and no prior systemic therapy in the advanced or metastatic setting. Participants enrolled on or after Protocol Version 7 will have baseline disease PD-L1 negative status defined as Dako 22C3 assay CPS \<10. For participants in Cohort 2 receiving nab-paclitaxel, the schedule for nab-paclitaxel is a separate 28-day cycle. The dosing regimen of nab-paclitaxel is 100 mg/m2 IV over 30 minutes on Days 1, 8, and 15 of each 28-day cycle. For participants in Cohort 2 receiving gemcitabine plus carboplatin, the dosing regimen is gemcitabine 1000 mg/m² plus carboplatin area under the curve (AUC) 2 IV on Days 1 and 8 every 21 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Intratumoral tavokinogene telseplasmid delivered by electroporation every 6 weeks
Intravenous 3 weekly treatments
Device that administers electroporation
intravenous on days 1, 8 and 15 of each 28 day cycle
intravenous on days 1 and 8 of every 21 days
University of Arizona
Tucson, Arizona, United States
UC San Diego
La Jolla, California, United States
Stanford University Medical Center
Palo Alto, California, United States
The Lundquist Institute
Torrance, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
University of Washington, Seattle Cancer Care Alliance
Seattle, Washington, United States
...and 4 more locations
Cohort 1: Objective Response Rate (ORR)
ORR by Investigator review based on RECIST v1.1
Time frame: Approximately 2 years
Cohort 2: Objective Response Rate (ORR)
ORR by Investigator review based on RECIST v1.1
Time frame: Approximately 2 years
Duration of Response (DOR)
Cohort 1 \& Cohort 2: DOR by Investigator based on RECIST v1.1
Time frame: Approximately 2 years
Progression Free Survival (PFS)
Cohort 1 \& Cohort 2: PFS by Investigator based on RECIST v1.1
Time frame: Approximately 2 years
Immune Progression Free Survival (iPFS)
Cohort 1 \& Cohort 2: iPFS by Investigator review based on iRECIST
Time frame: Approximately 2 years
Immune Objective Response Rate (iORR)
Cohort 1 \& Cohort 2: iORR by Investigator review based on iRECIST
Time frame: Approximately 2 years
Disease Control Rate (DCR)
Cohort 1 \& Cohort 2: DCR by Investigator based on RECIST v1.1
Time frame: Approximately 2 years
Overall Survival
Cohorts 1 and 2: Overall Survival for Cohorts
Time frame: Approximately 2 years
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