hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse

Breast Cancer Clinical Trial

— TRT-001  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960594
• Other study ID #: TRT-001
• Status: Completed
• Phase: Phase 1
• Start date: December 2014
• Est. completion date: November 9, 2018

Study information

• Verified date: November 2018
• Source: Inovio Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT02327468

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma, Hepatocellular
• ColoRectal Cancer
• Colorectal Neoplasms
• Esophageal Cancer
• Esophageal Neoplasms
• Gastric Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• HepatoCellular Carcinoma
• Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Pancreatic Neoplasms
• Recurrence
• Stomach Neoplasms

Intervention

Biological:
• INO-1400

• INO-9012

• INO-1401

Locations

Country	Name	City	State
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (7)

Lead Sponsor	Collaborator
Inovio Pharmaceuticals	Barbara Ann Karmanos Cancer Institute, Mayo Clinic, Thomas Jefferson University, University of North Carolina, University of Pennsylvania, University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03		Up to 2 years from first study treatment
Primary	Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site		Up to 14 weeks
Primary	Changes in safety laboratory parameters		Up to 2 years from first study treatment

External Links

•   Sponsor's Website