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Therapy Name H3.3K27M peptide vaccine + Montanide ISA 51 + Nivolumab + Poly ICLC + Tetanus Toxoid peptide
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
H3.3K27M peptide vaccine H3.3K27M-specific Peptide Vaccine H3.3K27M peptide vaccine is vaccine based on histone 3 variant 3 (H3.3) harboring a K27M mutation (also referred as K28M), which potentially induces anti-tumor immune response against H3.3 K27M (K28M)-expressing tumor cells (Neuro-Oncology, Vol.21, suppl_6, Abs nr: PDCT-17 (LTBK-11)).
Montanide ISA 51
Nivolumab Opdivo MDX-1106|BMS-936558 Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer (NSCLC) progressed on prior therapies, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma (UC) , esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) for melanoma, renal cell carcinoma (RCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy for PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy for metastatic or recurrent NSCLC without EGFR or ALK alterations, with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, with Cabometyx (cabozantinib) for advanced RCC, with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, and with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic UC (FDA.gov).
Poly ICLC Hiltonol Hiltonol (poly ICLC) is a synthetic double stranded RNA complex, which induces interferon production and stimulates anti-tumor immune response (PMID: 22126373).
Tetanus Toxoid peptide

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02960230 Phase Ib/II H3.3K27M peptide vaccine + Montanide ISA 51 + Nivolumab + Poly ICLC + Tetanus Toxoid peptide H3.3K27M peptide vaccine + Montanide ISA 51 + Poly ICLC + Tetanus Toxoid peptide H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas Completed USA | CHE 0


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