Therapy Detail

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Therapy Name Nivolumab + ONC201
Synonyms
Therapy Description

ONC201 (TIC-10) binds to the G-protein coupled receptor, DRD2, leading to inactivation of AKT and ERK, which relocates Foxo3a to the nucleus and then leads to tumor cell apoptosis mediated by (TNF)-related apoptosis-inducing ligand (TRAIL) signaling (PMID: 23390247).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Nivolumab Opdivo MDX-1106|BMS-936558 Immune Checkpoint Inhibitor 135 PD-L1/PD-1 antibody 78 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, small cell lung cancer, 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 non-small cell lung cancer without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations, 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).
ONC201 TIC-10|TIC10 Akt Inhibitor (Pan) 20 ERK Inhibitor (pan) 16 ONC201 (TIC-10) binds to the G-protein coupled receptor, DRD2, leading to inactivation of AKT and ERK, which relocates Foxo3a to the nucleus and then leads to tumor cell apoptosis mediated by (TNF)-related apoptosis-inducing ligand (TRAIL) signaling (PMID: 23390247) and targets the mitochondrial protease, ClpP (PMID: 31021596, PMID: 31702782, PMID: 31456142).

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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
NCT03791398 Phase Ib/II Nivolumab + ONC201 BrUOG 379 Phase Ib/II Trial ONC201 + Nivolumab in MSS mCRC (379) Active, not recruiting USA 0


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