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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 : Recruiting
First Posted : November 9, 2016
Last Update Posted : November 24, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This is a Phase I, open label study to evaluate the safety, tolerability, and immunogenicity of INO-1400 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 six 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 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 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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


Contacts
Contact: Inovio Call Center 267-440-4237 clinical.trials@inovio.com

Locations
United States, Michigan
Karmanos Cancer Center (Wayne State University) Recruiting
Detroit, Michigan, United States, 48201
Contact: Allison Wolgast    313-576-8994    wolgasta@karmanos.org   
Principal Investigator: Anthony Shields, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Ashish Chintakunlawar, MBBS, PhD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Catherine Griffin    919-966-0444    catherine_griffin@med.unc.edu   
Principal Investigator: Autumn McRee, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Colleen Redlinger    215-220-9693    colleen.redlinger@uphs.upenn.edu   
Principal Investigator: Robert Vonderheide, MD, PhD         
Thomas Jefferson University Hospitial Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Rutika Kokate    215-955-1661    rutika.kokate@jefferson.edu   
Principal Investigator: Ashwin Sama, MD         
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Natalie Streeter    412-235-1276    streetern@upmc.edu   
Principal Investigator: Herbert Zeh, MD         
Sponsors and Collaborators
Inovio Pharmaceuticals
University of Pennsylvania
University of North Carolina
Thomas Jefferson University
University of Pittsburgh
Wayne State University
Mayo Clinic
Investigators
Principal Investigator: Robert Vonderheide, MD, PhD University of Pennsylvania
Principal Investigator: Autumn McRee, MD University of North Carolina
Principal Investigator: Ashwin Sama, MD Thomas Jefferson University Hospitial
Principal Investigator: Anthony Shields, MD Karmanos Cancer Center (Wayne State University)
Principal Investigator: Herbert Zeh, MD University of Pittsburgh
Principal Investigator: Ashish Chintakuntlawar, MBBS, PhD Mayo Clinic (Rochester, MN)
More Information

Additional Information:
Responsible Party: Inovio Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02960594     History of Changes
Obsolete Identifiers: NCT02327468
Other Study ID Numbers: TRT-001
First Posted: November 9, 2016    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
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:
Colorectal Neoplasms
Pancreatic Neoplasms
Carcinoma, Hepatocellular
Stomach Neoplasms
Head and Neck Neoplasms
Esophageal Neoplasms
Recurrence
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Liver Diseases
Stomach Diseases
Esophageal Diseases
Disease Attributes
Pathologic Processes