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K27M peptide · 1 trial · 3 indications
Safety of the vaccine (Strata A and B) or vaccine in combination with nivolumab (Stratum C) will be assessed for participants who received the vaccination. The severity of toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)version 5.0. and include any clinically-significant lab abnormalities meeting Grade 3, 4, or 5 criteria according to CTCAE. Grade 1 \& 2 AEs will be summarized if probably, possible, or definitely related to study therapy. Descriptive statistics will be utilized to display the data on toxicity reported by participants.
OS12 is defined as the percentage of participants still alive at 12 months, and is the clinical efficacy, primary endpoint for Stratum A. Any eligible participant that received at least one dose of the K27M/TT vaccine will be considered evaluable for clinical efficacy. OS12 will be censored at the last contact date and estimated using the Kaplan-Meier method.
| Arm | Type | Description |
|---|---|---|
| Stratum A: Newly Diagnosed DIPG | EXPERIMENTAL | Newly diagnosed children with diffuse intrinsic pontine glioma who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid (TT) peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks. |
| Stratum B: Newly Diagnosed Glioma (non-DIPG) | EXPERIMENTAL | Newly diagnosed children with gliomas other than DIPG who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks. |
| Stratum C: Newly Diagnosed DIPG or other Midline Glioma | EXPERIMENTAL | Newly diagnosed children with DIPG or other midline gliomas (excluding primary spinal cord tumors) who are positive for HLA-A2 (02:01) and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Nivolumab will also be given via IV. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks. Nivolumab will continue to be given every 3 weeks throughout all of treatment. |
| Name | Type | Description |
|---|---|---|
| K27M peptide | BIOLOGICAL | K27M peptide vaccine, combined with Tetanus Toxoid peptide, emulsified in montanide. Poly-ICLC will be given concurrently |
| Nivolumab | DRUG | anti-programmed cell death protein 1 (PD-1) monoclonal antibody |
Inclusion Criteria: * Stratum A: • Newly diagnosed children (3-21 years old) with DIPG who are positive for the H3.3K27M mutation (positive testing in Clinical Laboratory Improvement Amendments (CLIA) laboratory) that underwent standard radiation therapy. * Stratum B: • Newly diagnosed childr...
K27M peptide is an investigational monoclonal antibody being studied for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG), a type of brain tumor. It is also being evaluated for other gliomas, including Diffuse Midline Glioma with the H3 K27M mutation. The drug is currently in Phase 1 clinical development.
K27M peptide is designed to target the H3 K27M mutation, a specific genetic alteration found in certain gliomas, including Diffuse Intrinsic Pontine Glioma. This mutation is a key driver of tumor growth, and the drug aims to direct the immune system against cancer cells carrying this mutation.
K27M peptide is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Diffuse Intrinsic Pontine Glioma and other H3 K27M-mutant gliomas.
K27M peptide is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The drug is being evaluated for safety, dosing, and preliminary efficacy in patients with Diffuse Intrinsic Pontine Glioma and other gliomas.
K27M peptide is being studied in clinical trial NCT02960230, titled "H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas." This Phase 1 trial has been completed and enrolled 50 participants with Diffuse Intrinsic Pontine Glioma, Glioma, and Diffuse Midline Glioma with the H3 K27M mutation.
K27M peptide is the active component of the H3.3K27M peptide vaccine being studied in clinical trial NCT02960230. The vaccine combines the K27M peptide with nivolumab, an immunotherapy agent, to treat children with newly diagnosed Diffuse Intrinsic Pontine Glioma and other H3 K27M-mutant gliomas.