Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma
Summary
Monocentric randomized phase I/II trial, including 24 patients diagnosed with relapsing glioblastoma (GBM) irrespective of MGMT and IDH gene status. Following diagnosis of relapsing glioblastoma by either brain CT scan or MRI, patients will be randomized in 2 arms: 1. Arm 1: IMA950 mixed with Poly-ICLC administered subcutaneously 2. Arm 2: Pembrolizumab 200mg q3w IV and IMA950 mixed with Poly-ICLC administered subcutaneously The first phase of treatment will last 6 weeks, then surgery will be performed (done if clinically possible ad indicated). In case of available brain tissue, extensive analysis of the tumor immune response will be performed. Assessment of systemic immune response by PBMC immunomonitoring will be systematically done before and after surgery.
Timeline
- Start
- 2018-10-25
- Primary completion
- 2023-12-31
- Completion
- 2024-04-24
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Hiltonol | Other / unclassified | — | Subcutaneous |
| Background | IMA950 | Vaccine | — | Subcutaneous |