drugset / Trial / NCT03422094
Neoantigen-based Personalized Vaccine Combined With Immune Checkpoint Blockade Therapy in Patients With Newly Diagnosed, Unmethylated Glioblastoma
Phase 1
Terminated
3 enrolled
Washington University School of Medicine
Bristol-Myers Squibb · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a single institution, open-label, multi-arm, pilot study assessing the safety, feasibility, and immunogenicity of a personalized neoantigen-based vaccine plus poly-ICLC (NeoVax) combined with immune checkpoint inhibitors in subjects with newly diagnosed, unmethylated glioblastoma.
Timeline
- Start
- 2018-10-31
- Primary completion
- 2020-04-26
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ipilimumab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Subject | NeoVax | Vaccine | 1.5 mg | Subcutaneous |
| Subject | Nivolumab | Monoclonal antibody | 3 mg/kg | Intravenous |
| Subject | Nivolumab | Monoclonal antibody | 480 mg | Intravenous |
| Background | Hiltonol | Other / unclassified | 1.5 mg | Subcutaneous |