Clinical trial NCT02960594: hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
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
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Lead sponsor: Inovio Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: University of Pennsylvania
name: University of North Carolina
name: Thomas Jefferson University
name: University of Pittsburgh
name: Barbara Ann Karmanos Cancer Institute
name: Mayo Clinic
First posted: 2016-11-09
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Adverse events graded in accordance with "Common Terminology Criteria for Adverse Events (CTCAE)", NCI version 4.03
timeFrame: Up to 2 years from first study treatment
measure: Injection site reactions including, but not necessarily limited to, local skin erythema, induration, pain and tenderness at administration site
timeFrame: Up to 14 weeks
measure: Changes in safety laboratory parameters
timeFrame: Up to 2 years from first study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Robert Vonderheide, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina
name: Autumn McRee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thomas Jefferson University Hospitial
name: Jennifer Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karmanos Cancer Center (Wayne State University)
name: Anthony Shields, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Nathan Bahary, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic, Rochester, MN
name: Ashish Chintakuntlawar, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: