Therapy Detail

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Therapy Name Cyclophosphamide + IRX-2 + Nivolumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Cyclophosphamide Cytoxan CPM Chemotherapy - Alkylating 16 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).
IRX-2 Citoplurikin Citoplurikin (IRX-2) is an immunotherapeutic comprising a mixture of the cytokines IL-2, IL-1beta, IFN-gamma, TNF-alpha, IL-8, IL-6, and GM-CSF, which may increase anti-tumor immune response (PMID: 19180118, PMID: 23408925, PMID: 32738599, PMID: 31831558).
Nivolumab Opdivo MDX-1106|BMS-936558 Immune Checkpoint Inhibitor 153 PD-L1/PD-1 antibody 100 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, esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) in patients with melanoma, renal cell carcinoma, 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 in patients with PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent NSCLC without EGFR or ALK alterations, in combination with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma, and in combination with fluoropyrimidine- and platinum-containing chemotherapy in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (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
NCT03575234 Phase Ib/II Cyclophosphamide + IRX-2 + Nivolumab Nivolumab & IRX-2 With Surgery for Resectable Stage III-IVA Oral Cavity Cancer or HPV-Positive Oropharyngeal Cancer Withdrawn USA 0
NCT03655002 Phase I Cyclophosphamide + IRX-2 + Nivolumab IRX-2, Cyclophosphamide, and Nivolumab in Treating Participants With Recurrent or Metastatic and Refractory Liver Cancer Active, not recruiting USA 0
NCT03758781 Phase I Cyclophosphamide + IRX-2 + Nivolumab IRX-2 Regimen Combined With Nivolumab in Recurrent/Metastatic Solid Tumors Completed USA 0


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