hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
NCT ID: NCT02960594
Last Updated: 2018-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
93 participants
INTERVENTIONAL
2014-12-31
2018-11-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Arm 1
2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-1400
Arm 2
8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-1400
Arm 3
2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-1400
INO-9012
Arm 4
2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-1400
INO-9012
Arm 5
8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-1400
INO-9012
Arm 6
8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-1400
INO-9012
Arm 7
2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-1401
Arm 8
8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-1401
Arm 9
8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-9012
INO-1401
Arm 10
8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
INO-9012
INO-1401
Interventions
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INO-1400
INO-9012
INO-1401
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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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
Inovio Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Vonderheide, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Autumn McRee, MD
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina
Jennifer Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Thomas Jefferson University Hospitial
Anthony Shields, MD
Role: PRINCIPAL_INVESTIGATOR
Karmanos Cancer Center (Wayne State University)
Nathan Bahary, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Ashish Chintakuntlawar, MBBS, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic, Rochester, MN
Locations
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Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Related Links
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Sponsor's Website
Other Identifiers
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TRT-001
Identifier Type: -
Identifier Source: org_study_id
NCT02327468
Identifier Type: -
Identifier Source: nct_alias
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