NCT03567720

Tavo and Pembrolizumab With or Without Chemotherapy in Patients With Inoperable Locally Advanced or Metastatic TNBC

A Phase 2 Multi-Cohort, Open-Label Study of Intratumoral Tavokinogene Telseplasmid Plus Electroporation in Combination With Pembrolizumab +/- Chemotherapy in Patients With Inoperable Locally Advanced/Metastatic Triple-Negative Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: OncoSec Medical Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	tavokinogene telseplasmid	Intratumoral tavokinogene telseplasmid delivered by electroporation every 6 weeks
BIOLOGICAL	Pembrolizumab	Intravenous 3 weekly treatments
DEVICE	Immunopulse	Device that administers electroporation
DRUG	nab paclitaxel	intravenous on days 1, 8 and 15 of each 28 day cycle
DRUG	gemcitabine plus carboplatin	intravenous on days 1 and 8 of every 21 days

Timeline

• Start date: 2018-10-11
• Primary completion: 2024-04-01
• Completion: 2024-09-01
• First posted: 2018-06-26
• Last updated: 2023-06-01

Locations

14 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study
• FDA-regulated device study