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

Study 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.

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Key things to know

Main goalPrevention

This describes the study’s primary purpose.

What is being studiedINO-1400 and INO-9012

Plus 1 other study approaches.

Who it may be forBreast Cancer · Lung Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Nov 19, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Inovio Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Prevention
Study type: Interventional
Phase: Phase 1
Sponsor: Inovio Pharmaceuticals
Interventions being studied: Biological: INO-1400; Biological: INO-9012; Biological: INO-1401

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach

Immunotherapy→Surgery→

Study topics

After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Barbara Ann Karmanos Cancer InstituteDetroit, Michigan
Mayo ClinicRochester, Minnesota
University of North CarolinaChapel Hill, North Carolina
University of PennsylvaniaPhiladelphia, Pennsylvania
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania
University of PittsburghPittsburgh, Pennsylvania

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Nov 19, 2018. Always confirm current availability with the study team.

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