Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Poly-ICLC · 1 trial · 1 indication
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...
Poly-ICLC is being studied for the treatment of glioblastoma, a type of brain cancer. It is part of an investigational personalized genomic vaccine approach combined with Tumor Treating Fields (TTFields) therapy. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
Poly-ICLC is being developed by NovoCure Limited, a company traded on the NASDAQ under the ticker symbol NVCR. The company is conducting clinical research to evaluate the drug's safety and immunogenicity in patients with glioblastoma.
Poly-ICLC is in Phase 1 clinical development. It is an investigational drug being studied in an active clinical trial for glioblastoma. The drug has not been approved by the FDA or any other regulatory agency, and its safety and efficacy are still being evaluated.
Poly-ICLC is being evaluated in a Phase 1 clinical trial with the identifier NCT03223103. This trial is titled 'Safety and Immunogenicity of Personalized Genomic Vaccine and Tumor Treating Fields (TTFields) to Treat Glioblastoma' and is active but not recruiting participants. The trial is being conducted in the United States.
Poly-ICLC is a small molecule being studied as part of a personalized genomic vaccine for glioblastoma. It is intended to stimulate the immune system to recognize and attack tumor cells. The drug is combined with Tumor Treating Fields (TTFields) therapy, which uses electric fields to disrupt cancer cell division.