Trial record 1 of 1 for:
INO-1400
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 |
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Recruitment Status :
Completed
First Posted : November 9, 2016
Last Update Posted : November 19, 2018
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Sponsor:
Inovio Pharmaceuticals
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
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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 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Interleukin-12
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1
2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
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Biological: INO-1400
Other Name: hTERT |
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Experimental: Arm 2
8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
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Biological: INO-1400
Other Name: hTERT |
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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
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Biological: INO-1400
Other Name: hTERT Biological: INO-9012 Other Name: IL-12 |
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Experimental: Arm 4
2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
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Biological: INO-1400
Other Name: hTERT Biological: INO-9012 Other Name: IL-12 |
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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
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Biological: INO-1400
Other Name: hTERT Biological: INO-9012 Other Name: IL-12 |
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Experimental: Arm 6
8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
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Biological: INO-1400
Other Name: hTERT Biological: INO-9012 Other Name: IL-12 |
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Experimental: Arm 7
2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
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Biological: INO-1401
Other Name: SynCon TERT |
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Experimental: Arm 8
8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
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Biological: INO-1401
Other Name: SynCon TERT |
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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
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Biological: INO-9012
Other Name: IL-12 Biological: INO-1401 Other Name: SynCon TERT |
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Experimental: Arm 10
8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12
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Biological: INO-9012
Other Name: IL-12 Biological: INO-1401 Other Name: SynCon TERT |
Primary Outcome Measures :
- 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 ]
- 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 ]
- Changes in safety laboratory parameters [ Time Frame: Up to 2 years from first study treatment ]
Information from the National Library of Medicine
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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;
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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
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
| 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
| 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) |
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 19, 2018 |
| Last Verified: | November 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Inovio Pharmaceuticals:
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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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Carcinoma, Hepatocellular Recurrence Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Liver Neoplasms Liver Diseases |
Disease Attributes Pathologic Processes Interleukin-12 Immunologic Factors Physiological Effects of Drugs Adjuvants, Immunologic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |