hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse (TRT-001)

November 15, 2018 updated by: Inovio Pharmaceuticals

A Multi-center Study of hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse Post Definitive Surgery and Standard Therapy

This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 or INO-1401 alone or in combination with INO-9012, delivered by electroporation in subjects with high-risk solid tumor cancer with no evidence of disease after surgery and standard therapy. Subjects will be enrolled into one of ten treatment arms. Subjects will be assessed according to standard of care. Restaging and imaging studies will be performed to assess disease relapse per NCCN guidelines. RECIST will be used to validate the findings in cases of relapse.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Pittsburgh, Pennsylvania, United States, 15232
        • University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Signed and dated written IRB approved informed consent;
  • 2. Males or females aged ≥18 years;

  • 3. Subjects with breast, lung or pancreatic carcinoma who are at high risk of relapse post definitive therapy at least 4 and no more than 24 weeks from completion of definitive therapy at the time of signing informed consent as described below for each indication:

    • Breast carcinoma:
    • Lung carcinoma:
    • Pancreatic carcinoma:
    • Head and neck squamous cell carcinoma:
    • Ovarian cancer:
    • Colorectal cancer
    • Gastric and esophageal cancer
    • Hepatocellular carcinoma

Exclusion Criteria:

  • 1. Previous treatment wth any TERT or IL-12 containing therapy, or any other DNA immunotherapy;
  • 2. Any concurrent condition requiring the continued or anticipated use of systemic steroids (excluding non-systemic inhaled, topical skin and/or eye drop-containing corticosteroids) or immunosuppressive therapy (excludes low dose methotrexate). All other systemic corticosteroids must be discontinued at least 4 weeks prior to first Study Treatment;
  • 3. Administration of any vaccine within 4 weeks of the first study treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm 1
2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-1400
Other Names:
  • hTERT
EXPERIMENTAL: Arm 2
8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-1400
Other Names:
  • hTERT
EXPERIMENTAL: Arm 3
2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-1400
Other Names:
  • hTERT
Biological: INO-9012
Other Names:
  • IL-12
EXPERIMENTAL: Arm 4
2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-1400
Other Names:
  • hTERT
Biological: INO-9012
Other Names:
  • IL-12
EXPERIMENTAL: Arm 5
8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-1400
Other Names:
  • hTERT
Biological: INO-9012
Other Names:
  • IL-12
EXPERIMENTAL: Arm 6
8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-1400
Other Names:
  • hTERT
Biological: INO-9012
Other Names:
  • IL-12
EXPERIMENTAL: Arm 7
2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-1401
Other Names:
  • SynCon TERT
EXPERIMENTAL: Arm 8
8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-1401
Other Names:
  • SynCon TERT
EXPERIMENTAL: Arm 9
8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-9012
Other Names:
  • IL-12
Biological: INO-1401
Other Names:
  • SynCon TERT
EXPERIMENTAL: Arm 10
8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
Biological: INO-9012
Other Names:
  • IL-12
Biological: INO-1401
Other Names:
  • SynCon TERT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
Time Frame: Up to 2 years from first study treatment
Up to 2 years from first study treatment
Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site
Time Frame: Up to 14 weeks
Up to 14 weeks
Changes in safety laboratory parameters
Time Frame: Up to 2 years from first study treatment
Up to 2 years from first study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inovio Pharmaceuticals

Collaborators

Mayo Clinic
University of Pennsylvania
University of Pittsburgh
Thomas Jefferson University
Barbara Ann Karmanos Cancer Institute
University of North Carolina

Investigators

  • Principal Investigator: Robert Vonderheide, MD, PhD, University of Pennsylvania
  • Principal Investigator: Autumn McRee, MD, University of North Carolina
  • Principal Investigator: Jennifer Johnson, MD, Thomas Jefferson University Hospitial
  • Principal Investigator: Anthony Shields, MD, Karmanos Cancer Center (Wayne State University)
  • Principal Investigator: Ashish Chintakuntlawar, MBBS, PhD, Mayo Clinic, Rochester, MN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ACTUAL)

November 9, 2018

Study Completion (ACTUAL)

November 9, 2018

Study Registration Dates

First Submitted

November 4, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (ESTIMATE)

November 9, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 19, 2018

Last Update Submitted That Met QC Criteria

November 15, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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