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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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Inovio Pharmaceuticals
Sponsor:
Collaborators:
University of Pennsylvania
University of North Carolina
Thomas Jefferson University
University of Pittsburgh
Wayne State University
Mayo Clinic
Information provided by (Responsible Party):
Inovio Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02960594
First received: November 4, 2016
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
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 Intervention 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
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Inovio Pharmaceuticals:

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 ]

Estimated Enrollment: 54
Study Start Date: December 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02960594

Contacts
Contact: Robert Samuels 267-440-4256 rsamuels@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: Yuko Nishida    215-955-1661    yuko.nishida@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: Weijing Sun, 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: Weijing Sun, 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
Study First Received: November 4, 2016
Last Updated: January 26, 2017
Individual Participant Data  
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
Stomach Neoplasms
Carcinoma, Hepatocellular
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
Stomach Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Liver Diseases
Esophageal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on March 24, 2017