drugset / Trial / NCT03544723
Safety and Efficacy of p53 Gene Therapy Combined With Immune Checkpoint Inhibitors in Solid Tumors.
NaSingle-groupOpen-labelTreatment
Summary
This is a single arm Phase 2 study of the combination of adenoviral p53 (Ad-p53) gene therapy administered intra-tumorally with approved immune checkpoint inhibitors in patients with recurrent or metastatic cancers. Comparison will be made to historical data. General safety and efficacy using RECIST 1.1 and Immune-Related Response Criteria as well as ECOG performance will be utilized.
Timeline
- Start
- 2018-10-01
- Primary completion
- 2022-06-30
- Completion
- 2022-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CONTUSUGENE LADENOVEC | Unknown | — | Other |
| Background | Atezolizumab | Monoclonal antibody | — | Intravenous |
| Background | Durvalumab | Monoclonal antibody | — | Intravenous |
| Background | Nivolumab | Monoclonal antibody | — | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | — | Intravenous |