Therapy Detail

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Therapy Name Nivolumab + Sitravatinib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Nivolumab Opdivo MDX-1106|BMS-936558 Immune Checkpoint Inhibitor 147 PD-L1/PD-1 antibody 89 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).
Sitravatinib MGCD516 AXL Inhibitor 28 DDR1 Inhibitor 8 DDR2 inhibitor 7 KIT Inhibitor 53 MERTK Inhibitor 13 MET Inhibitor 55 RET Inhibitor 45 Trk Receptor Inhibitor (Pan) 29 TYRO3 Inhibitor 8 VEGFR Inhibitor (Pan) 33 Sitravatinib (MGCD516) inhibits several receptor tyrosine kinases including AXL, MET, KIT, VEGFR1-3, TYRO3, RET family members, TRK family members, DDR, and Eph family members, resulting in abrogation of downstream signaling and decreased cell proliferation in tumors overexpressing the target proteins (PMID: 26675259, PMID: 30501104, PMID: 32525624).

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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
NCT03606174 Phase II Nivolumab + Sitravatinib Sitravatinib and Nivolumab in Urothelial Carcinoma Study Recruiting USA 0
NCT04887870 Phase II Ipilimumab + Sitravatinib Nivolumab + Sitravatinib Enfortumab vedotin-ejfv + Sitravatinib Pembrolizumab + Sitravatinib Sitravatinib Study of Sitravatinib With or Without Other Anticancer Therapies Receiving Clinical Benefit From Parent Study Recruiting USA 0
NCT03680521 Phase II Nivolumab + Sitravatinib Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma Active, not recruiting USA 0
NCT03575598 Phase I Nivolumab + Sitravatinib Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study Completed CAN 0
NCT04904302 Phase II Nivolumab + Sitravatinib Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer Recruiting USA 0
NCT03906071 Phase III Docetaxel Nivolumab + Sitravatinib Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (SAPPHIRE) Active, not recruiting USA | ITA | FRA | ESP | DEU | CAN | BEL 5
NCT03015740 Phase Ib/II Nivolumab + Sitravatinib MGCD516 Combined With Nivolumab in Renal Cell Cancer (RCC) Active, not recruiting USA 0
NCT02954991 Phase II Nivolumab + Sitravatinib Mocetinostat + Nivolumab Glesatinib + Nivolumab Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer Completed USA 0


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