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Therapy Name Cyclophosphamide + Fludarabine + HPVST cells + Nivolumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cyclophosphamide Cytoxan CPM Chemotherapy - Alkylating 18 Cytoxan (cyclophosphamide) is an alkylating agent, which inhibits DNA replication (NCI Drug Dictionary). Cytoxan (cyclophosphamide) is FDA approved in multiple hematological malignancies, breast cancer, neuroblastoma, ovarian cancer, and retinoblastoma (NCI Drug Dictionary).
Fludarabine Fludara FAMP|Fludarabine phosphate Flurdara (fludarabine) is converted to 2-fluoro-ara-ATP intracellularly, which potentially inhibits DNA polymerase alpha, ribonucleotide reductase and DNA primase, leading to decreased DNA synthesis and reduced tumor growth (NCI Drug Dictionary)
HPVST cells Autologous HPV-16/18 E6/E7-specific TGF-beta-resistant T Lymphocytes HPVST cells are autologous T cells that are stimulated with HPV-16/18-loaded dendritic cells and are also engineered to express a dominant-negative TGF-beta receptor II that inhibits TGF-beta signaling, which potentially results in increased T cell response against HPV-16/18-positive tumor cells (NCI Drug Dictionary).
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).

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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
NCT02379520 Phase I Cyclophosphamide + Fludarabine + HPVST cells + Nivolumab HPVST cells HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA (HESTIA) Active, not recruiting USA 0


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