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Therapy Name	MT-8421 + Nivolumab
Synonyms
Therapy Description

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
MT-8421		MT8421\|MT 8421	CTLA4 Antibody 33	MT-8421 is an engineered toxin body that targets regulatory T-cells expressing high levels of CTLA-4, potentially resulting in decreases in regulatory T-cells in the tumor microenvironment and increased proliferation of CD8- and CD4-positive T-cells (Journal for ImmunoTherapy of Cancer (2022), 83 (Supplement 2): 817).
Nivolumab	Opdivo	MDX-1106\|BMS-936558	Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 129	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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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT06034860	Phase I	MT-8421 + Nivolumab MT-8421	Study of MT-8421 as Monotherapy and in Combination With Nivolumab in Patients With Selected Advanced Solid Cancer Types	Terminated	USA	0

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