MedTrace Logo

Optimizing Antitumor Immunity Using Plasmid Electroporation, Pembrolizumab, and Epacadostat

NCT03823131 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2023-05-09

Study results available
· View outcomes & findings →

Summary

This phase II trial studies how well tavokinogene telseplasmid with electroporation (tavo-EP), pembrolizumab, and epacadostat work in treating patients with squamous cell carcinoma of the head and neck that cannot be removed by surgery. Tavokinogene telseplasmid with electroporation is a gene therapy that may delay of tumor growth and which may have less toxicity than other methods of gene delivery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Epacadostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tavokinogene telseplasmid with electroporation, pembrolizumab, and epacadostat may work better in treating squamous cell carcinoma of the head and neck.

Conditions

  • Metastatic Head and Neck Squamous Cell Carcinoma
  • Recurrent Head and Neck Squamous Cell Carcinoma
  • Unresectable Head and Neck Squamous Cell Carcinoma

Interventions

DEVICE

ImmunoPulse

Intratumoral

DRUG

Epacadostat

Given PO

DRUG

Pembrolizumab

Given IV

BIOLOGICAL

CORVax

Intratumoral

DRUG

Tavokinogene telseplasmid

Intratumoral

Sponsors & Collaborators

  • Incyte Corporation

    collaborator INDUSTRY

  • OncoSec Medical Incorporated

    collaborator INDUSTRY

  • Chase Heaton, MD

    lead OTHER

Principal Investigators

  • Chase Heaton, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2022-07-31
Completion
2022-07-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT03823131 on ClinicalTrials.gov