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Therapy Name | Nivolumab + Sitravatinib |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Nivolumab | Opdivo | MDX-1106|BMS-936558 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 | 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). |
Sitravatinib | MGCD516 | AXL Inhibitor 30 DDR1 Inhibitor 10 DDR2 inhibitor 7 KIT Inhibitor 57 MERTK Inhibitor 13 MET Inhibitor 59 RET Inhibitor 53 Trk Receptor Inhibitor (Pan) 32 TYRO3 Inhibitor 8 VEGFR Inhibitor (Pan) 36 | 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). |
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 |
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NCT03680521 | Phase II | Nivolumab + Sitravatinib | Neoadjuvant Sitravatinib in Combination With Nivolumab in Patients With Clear Cell Renal Cell Carcinoma | Completed | USA | 0 |
NCT03575598 | Phase I | Nivolumab + Sitravatinib | Sitravatinib (MGCD516) and Nivolumab in Oral Cavity Cancer Window Opportunity Study | Completed | CAN | 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 | Terminated | USA | 0 |
NCT03606174 | Phase II | Nivolumab + Sitravatinib | Sitravatinib and Nivolumab in Urothelial Carcinoma Study | Terminated | 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 | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CHE | CAN | BEL | 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 | Active, not recruiting | USA | 0 |
NCT03015740 | Phase Ib/II | Nivolumab + Sitravatinib | MGCD516 Combined With Nivolumab in Renal Cell Cancer (RCC) | Completed | USA | 0 |
NCT04904302 | Phase II | Nivolumab + Sitravatinib | Sitravatinib and Nivolumab for the Treatment of Metastatic or Advanced Clear Cell Renal Cell Cancer | Active, not recruiting | USA | 0 |