Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 1:34 AM
NCT ID:
NCT02960594
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02960594
Study Brief:
Protocol Section:
NCT02960594