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
-
-
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
|
Other Names:
|
|
EXPERIMENTAL: Arm 2
8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
|
Other Names:
|
|
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
|
Other Names:
Other Names:
|
|
EXPERIMENTAL: Arm 4
2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
|
Other Names:
Other Names:
|
|
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
|
Other Names:
Other Names:
|
|
EXPERIMENTAL: Arm 6
8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
|
Other Names:
Other Names:
|
|
EXPERIMENTAL: Arm 7
2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
|
Other Names:
|
|
EXPERIMENTAL: Arm 8
8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
|
Other Names:
|
|
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
|
Other Names:
Other Names:
|
|
EXPERIMENTAL: Arm 10
8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
|
Other Names:
Other Names:
|
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
Collaborators
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.