MedTrace Logo

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

NCT03567720 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-06-01

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Bridget O'Keeffe · OncoSec Medical Incorporated

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2024-04-30
Completion
2024-09-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567720 on ClinicalTrials.gov