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|Therapy Name||AVX901 + Pembrolizumab|
AVX901 is a virally based vaccine that infects cells and causes expression of a ERBB2 (HER2) ECD+TM protein that may activate the immune system to elicit a cytotoxic T-lymphocyte (CTL) response against ERBB2 (HER2)-expressing tumor cells (NCI Drug Dictionary).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|AVX901||DUKE-002-VRP|HER2 ECDTM VRP|HER2 VRP|VRP-HER2|VRP-neu||HER2 (ERBB2) Vaccine 12||AVX901 is a virally based vaccine that infects cells and causes expression of a ERBB2 (HER2) ECD+TM protein that may activate the immune system to elicit a cytotoxic T-lymphocyte (CTL) response against ERBB2 (HER2)-expressing tumor cells (PMID: 29081765).|
|Pembrolizumab||Keytruda||MK-3475||Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 86||Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, CD274 (PD-L1)-expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, with axitinib or lenvatinib in RCC, with Lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, in combination with platinum and fluoropyrimidine-based chemotherapy for patients with esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT03632941||Phase II||Pembrolizumab AVX901 + Pembrolizumab AVX901||A Study to Evaluate Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Breast Cancer||Recruiting||USA||0|