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|Therapy Name||Avelumab + Leuprolide + Palbociclib|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Avelumab||Bavencio||MSB0010718C||Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 96||Bavencio (avelumab) is a monoclonal antibody binds to human immunosuppressive ligand programmed death-ligand 1 (PD-L1, CD274) and blocks protein signaling, resulting in immune regulation and antitumor immunity (PMID: 26014098). Bavencio (avelumab) is FDA-approved for use in adult and pediatric patients of 12 years or older with metastatic Merkel cell carcinoma, as maintenance therapy in locally advanced or metastatic urothelial carcinoma (UC), in locally advanced or metastatic UC that progressed following chemotherapy, and in combination with axitinib as first-line therapy in advanced renal cell carcinoma (FDA.gov).|
|Leuprolide||Lupron||Leuprorelin||Lupron (leuprolide) is an agonist of gonadotropin releasing hormone (GnRH), which results decreased testosterone production in males and decreased estradiol production in females, potentially leading to decreased growth of androgen-positive tumors (NCI Drug Dictionary).|
|Palbociclib||Ibrance||PD0332991||CDK4/6 Inhibitor 12||Ibrance (palbociclib) is a selective inhibitor of cyclin-dependent kinase 4 (CDK4) and 6 (CDK6) (PMID: 19874578). Ibrance (palbociclib) is approved in combination with an aromatase inhibitor in postmenopausal patients with ER-positive, ERBB2 (HER2)-negative metastatic breast cancer, and in combination with Faslodex (fulvestrant) in patients with ER-positive, ERBB2 (HER2)-negative metastatic breast 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|
|NCT03573648||Phase II||Leuprolide Avelumab + Palbociclib + Tamoxifen Avelumab + Tamoxifen Leuprolide + Palbociclib Avelumab + Leuprolide Avelumab + Leuprolide + Palbociclib Tamoxifen Goserelin Palbociclib + Tamoxifen Avelumab + Goserelin Goserelin + Palbociclib Avelumab + Goserelin + Palbociclib||Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer||Recruiting||USA||0|