Trials / Completed
CompletedNCT02960594
hTERT Immunotherapy Alone or in Combination With IL-12 DNA Followed by Electroporation in Adults With Solid Tumors at High Risk of Relapse
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 93 (actual)
- Sponsor
- Inovio Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Breast Cancer
- Lung Cancer
- Pancreatic Cancer
- Head and Neck Cancer
- Ovarian Cancer
- ColoRectal Cancer
- Gastric Cancer
- Esophageal Cancer
- HepatoCellular Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | INO-1400 | |
| BIOLOGICAL | INO-9012 | |
| BIOLOGICAL | INO-1401 |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2018-11-09
- Completion
- 2018-11-09
- First posted
- 2016-11-09
- Last updated
- 2018-11-19
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02960594. Inclusion in this directory is not an endorsement.