drugset / Trial / NCT03265080
A Study of ADXS-NEO Expressing Personalized Tumor Antigens
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a Phase 1, open-label, multicenter study of ADXS-NEO administered alone and in combination with pembrolizumab in participants with select advanced or metastatic solid tumors. This study will be performed in 2 phases, a safety phase (Part A and Part B) and an efficacy phase (Part C).
Timeline
- Start
- 2018-03-28
- Primary completion
- 2019-10-24
- Completion
- 2020-11-12
Outcome
Outcome not reported
Stopped (Business): “Business decision”
Publications
- Results Hecht JR, Sheeri S, Heyburn J, Parsi M , Gutierrez AA, Tsai F. Clinical and immunogenicity data of a personalized neoantigen-Listeria vaccine in cancer patients: preliminary results. IO Combinations 360. Philadelphia, PA 20 June 2019.
- Results Tsai F, Goldman JW, Kosoff R, Heyburn JW, Sands T, Sheeri S, Petit R, Gutierrez AA, Hecht JR. Safety and Immunogenicity of a Personalized Neoantigen-Listeria Vaccine in Cancer Patients. Frontiers in Cancer Immunotherapy, The New York Academy of Sciences, May 14-15, 2019,New York, NY
- Results Hecht JR, Goldman JW, Hayes S, Balli D, Princiotta MF, Dennie JG, Heyburn J, Sands T, Sheeri S, Petit R, Gutierrez AA, Tsai F. Safety and immunogenicity of a personalized neoantigen -Listeria vaccine in cancer patients. AACR Annual Meeting 2019.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADXS-NEO | Vaccine | 1e+08 unknown | Intravenous |
| Subject | ADXS-NEO | Vaccine | 5e+08 unknown | Intravenous |
| Subject | ADXS-NEO | Vaccine | 1e+09 unknown | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |