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

Sponsor
Inovio Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02960594
Collaborator
University of Pennsylvania (Other), University of North Carolina (Other), Thomas Jefferson University (Other), University of Pittsburgh (Other), Barbara Ann Karmanos Cancer Institute (Other), Mayo Clinic (Other)
93
Enrollment
6
Locations
10
Arms
47.3
Duration (Months)
15.5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: INO-1400
  • Biological: INO-9012
  • Biological: INO-1401
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
93 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
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
Study Start Date :
Dec 1, 2014
Actual Primary Completion Date :
Nov 9, 2018
Actual Study Completion Date :
Nov 9, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03 [Up to 2 years from first study treatment]

    2. Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site [Up to 14 weeks]

    3. Changes in safety laboratory parameters [Up to 2 years from first study treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
      1. Signed and dated written IRB approved informed consent;
      1. Males or females aged ≥18 years;
      1. 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;
      1. 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;
      1. Administration of any vaccine within 4 weeks of the first study treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    2 Mayo Clinic Rochester Minnesota United States 55905
    3 University of North Carolina Chapel Hill North Carolina United States 27599
    4 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    5 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
    6 University of Pittsburgh Pittsburgh Pennsylvania United States 15232

    Sponsors and Collaborators

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

    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: Nathan Bahary, MD, University of Pittsburgh
    • Principal Investigator: Ashish Chintakuntlawar, MBBS, PhD, Mayo Clinic, Rochester, MN

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Inovio Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02960594
    Other Study ID Numbers:
    • TRT-001
    • NCT02327468
    First Posted:
    Nov 9, 2016
    Last Update Posted:
    Nov 19, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Inovio Pharmaceuticals
    Immunotherapy
    Human Telomerase Reverse Transcriptase (hTERT)
    Breast Neoplasms
    Lung Neoplasms
    Pancreatic Neoplasms
    High Risk of Relapse
    Post Definitive Surgery
    Post Adjuvant Therapy
    No Evidence of Disease
    Additional relevant MeSH terms:
    Recurrence

    Study Results

    No Results Posted as of Nov 19, 2018