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Trial record 1 of 1 for:    INO-1400
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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)

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ClinicalTrials.gov Identifier: NCT02960594
Recruitment Status : Completed
First Posted : November 9, 2016
Last Update Posted : November 19, 2018
Sponsor:
Collaborators:
University of Pennsylvania
University of North Carolina
Thomas Jefferson University
University of Pittsburgh
Barbara Ann Karmanos Cancer Institute
Mayo Clinic
Information provided by (Responsible Party):
Inovio Pharmaceuticals

Study Description
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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
Breast Cancer Lung Cancer Pancreatic Cancer Head and Neck Cancer Ovarian Cancer ColoRectal Cancer Gastric Cancer Esophageal Cancer HepatoCellular Carcinoma Biological: INO-1400 Biological: INO-9012 Biological: INO-1401 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : December 2014
Actual Primary Completion Date : November 9, 2018
Actual Study Completion Date : November 9, 2018

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Arms and Interventions
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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 Name: 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 Name: 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 Name: hTERT

Biological: INO-9012
Other Name: 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 Name: hTERT

Biological: INO-9012
Other Name: 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 Name: hTERT

Biological: INO-9012
Other Name: 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 Name: hTERT

Biological: INO-9012
Other Name: 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 Name: 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 Name: 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 Name: IL-12

Biological: INO-1401
Other Name: 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 Name: IL-12

Biological: INO-1401
Other Name: SynCon TERT


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Changes in safety laboratory parameters [ Time Frame: Up to 2 years from first study treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02960594


Locations
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United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
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
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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
More Information
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Additional Information:

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Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02960594    
Obsolete Identifiers: NCT02327468
Other Study ID Numbers: TRT-001
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
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:
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Recurrence
Disease Attributes
Pathologic Processes