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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)

Primary Purpose

Breast Cancer, Lung Cancer, Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

INO-1400

INO-9012

INO-1401

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Barbara Ann Karmanos Cancer Institute
Mayo Clinic
University of North Carolina
University of Pennsylvania
Thomas Jefferson University Hospital
University of Pittsburgh

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Description

2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Outcomes

Primary Outcome Measures

Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03

Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site

Changes in safety laboratory parameters

Secondary Outcome Measures

Full Information

NCT ID

NCT02960594

First Posted

November 4, 2016

Last Updated

November 15, 2018

Sponsor

Inovio Pharmaceuticals

Collaborators

University of Pennsylvania, University of North Carolina, Thomas Jefferson University, University of Pittsburgh, Barbara Ann Karmanos Cancer Institute, Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02960594

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

December 2014 (undefined)

Primary Completion Date

November 9, 2018 (Actual)

Study Completion Date

November 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inovio Pharmaceuticals

Collaborators

University of Pennsylvania, University of North Carolina, Thomas Jefferson University, University of Pittsburgh, Barbara Ann Karmanos Cancer Institute, Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Lung Cancer, Pancreatic Cancer, Head and Neck Cancer, Ovarian Cancer, ColoRectal Cancer, Gastric Cancer, Esophageal Cancer, HepatoCellular Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

93 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

2 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 2

Arm Type

Experimental

Arm Description

8 mg INO-1400 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 3

Arm Type

Experimental

Arm Description

2 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 4

Arm Type

Experimental

Arm Description

2 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 5

Arm Type

Experimental

Arm Description

8 mg INO-1400 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 6

Arm Type

Experimental

Arm Description

8 mg INO-1400 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 7

Arm Type

Experimental

Arm Description

2 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 8

Arm Type

Experimental

Arm Description

8 mg INO-1401 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 9

Arm Type

Experimental

Arm Description

8 mg INO-1401 + 0.5 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Arm Title

Arm 10

Arm Type

Experimental

Arm Description

8 mg INO-1401 + 2 mg INO-9012 delivered intramuscularly followed by electroporation at Day 0, Weeks 4, 8, and 12

Intervention Type

Biological

Intervention Name(s)

INO-1400

Other Intervention Name(s)

hTERT

Intervention Type

Biological

Intervention Name(s)

INO-9012

Other Intervention Name(s)

IL-12

Intervention Type

Biological

Intervention Name(s)

INO-1401

Other Intervention Name(s)

SynCon TERT

Primary Outcome Measure Information:

Title

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

Title

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

Title

Changes in safety laboratory parameters

Time Frame

Up to 2 years from first study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: