Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03223103 | Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma | PHASE1 | ACTIVE NOT_RECRUITING | 13 | — | — | Mar 1, 2018 | May 12, 2029 | Sep 10, 2025 | 1 | United States |
Safety and Tolerability of the personalized treatment regimen will be assessed in tandem using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03. NCI-CTCAE is a standard system for grading and reporting adverse events (AEs) in cancer clinical trials to document the occurrence and severity of AEs, with grades ranging from 1 (mild) to 5 (death). DLTs will be summarized and reported.
Feasibility of the personalized MTA vaccine will be defined as the successful administration of at least one (1) dose to subjects following tissue sample acquisition and will be expressed as the proportion or percentage subjects enrolled in the study who have successfully been administered at least one dose of the personalized MTA vaccine.
| Arm | Type | Description |
|---|---|---|
| Mutation-derived tumor vaccine | EXPERIMENTAL | MTA-based Personalized Vaccine (peptides + Poly-ICLC with Tumor Treating Fields |
| Name | Type | Description |
|---|---|---|
| Poly-ICLC | DRUG | Poly-ICLC 100mcg per peptide per dose |
| Tumor Treating Fields | DEVICE | an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM |
| Peptides | BIOLOGICAL | synthetic long peptides (SLP) as vaccine substrate |
Inclusion Criteria: * Age ≥ 18 * Histological confirmation of GBM (WHO grade IV). * Stable disease after treatment of radiation with concurrent chemotherapy. If the disease is not stable or progresses while in the study the patient is allowed to continue the study receiving the vaccine if the tumor...