Therapy Detail
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| Therapy Name | Cabozantinib + Nivolumab |
| Synonyms | |
| Therapy Description | |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Cabozantinib | Cometriq | Cabometyx|Cabozantinib-s-malate|XL184 | AXL Inhibitor 29 FLT3 Inhibitor 55 KIT Inhibitor 51 MET Inhibitor 53 RET Inhibitor 39 ROS1 Inhibitor 14 VEGFR2 Inhibitor 35 | Cometriq (Cabometyx, cabozantinib) inhibits several receptor tyrosine kinases, including VEGFR2, FLT3, AXL, MET, RET, ROS1 fusions, and c-KIT (PMID: 27370605, PMID: 21926191). Cometriq (cabozantinib) is FDA approved for use in patients with medullary thyroid cancer, Cabometyx (cabozantinib) is FDA approved for use in patients with advanced renal cell carcinoma, hepatocellular carcinoma previously treated with sorafenib, and in combination with Opdivo (nivolumab) in patients with advanced renal cell carcinoma (FDA.gov). |
| Nivolumab | Opdivo | MDX-1106|BMS-936558 | Immune Checkpoint Inhibitor 98 PD-L1/PD-1 antibody 69 | 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, and esophageal squamous cell carcinoma, 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). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| Unknown unknown | renal cell carcinoma | not applicable | Cabozantinib + Nivolumab | FDA approved | Actionable | In a Phase III trial (CHECKMATE-9ER) that supported FDA approval, Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) significantly improved median progression-free survival (16.6 vs 8.3 mo, HR 0.51, P < 0.0001), overall survival (HR 0.60, p<0.0010), and objective response rate (55.7% vs 27.1%, P < 0.0001) compared to Sutent (sunitinib) in patients with advanced real cell carcinoma (Annals of Oncology (2020) 31 (suppl_4): S1142-S1215. 10.1016/annonc/annonc325; NCT03141177). | detail... detail... detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT03635892 | Phase II | Cabozantinib + Nivolumab | A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma | Recruiting | USA | 0 |
| NCT04197310 | Phase II | Cabozantinib + Nivolumab | Cabozantinib and Nivolumab for Carcinoid Tumors | Recruiting | USA | 0 |
| NCT03367741 | Phase II | Cabozantinib + Nivolumab Nivolumab | Cabozantinib and Nivolumab in Treating Patients With Advanced, Recurrent or Metastatic Endometrial Cancer | Active, not recruiting | USA | CAN | 0 |
| NCT02496208 | Phase I | Ipilimumab Cabozantinib + Nivolumab | Cabozantinib Plus Nivolumab (CaboNivo) Alone or in Combination With Ipilimumab (CaboNivoIpi) in Patients With Advanced/Metastatic Urothelial Carcinoma and Other Genitourinary Tumors | Recruiting | USA | 0 |
| NCT04322955 | Phase II | Cabozantinib + Nivolumab | CYTO Reductive Surgery in Kidney Cancer Plus Immunotherapy and Targeted Kinase Inhibition (Cyto-KIK) | Recruiting | USA | 0 |
| NCT03793166 | Phase III | Nivolumab Cabozantinib + Nivolumab Cabozantinib Ipilimumab + Nivolumab | Nivolumab and Ipilimumab Followed by Nivolumab Versus Cabozantinib and Nivolumab in Treating Patients With Metastatic Untreated Renal Cell Cancer | Recruiting | USA | 1 |
| NCT04339738 | Phase II | Cabozantinib + Nivolumab Nivolumab + Paclitaxel Paclitaxel | Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma | Recruiting | USA | 1 |
| NCT03866382 | Phase II | Cabozantinib + Nivolumab Cabozantinib + Ipilimumab + Nivolumab | Cabozantinib in Combination With Nivolumab and Ipilimumab in Rare Genitourinary Tumors | Recruiting | USA | 1 |
| NCT04091750 | Phase II | Cabozantinib + Ipilimumab + Nivolumab Cabozantinib + Nivolumab | Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma | Recruiting | USA | 0 |
| NCT04151563 | Phase Ib/II | Lucitanib + Nivolumab Docetaxel Cabozantinib + Nivolumab Cabozantinib + Ipilimumab + Nivolumab Docetaxel + Nivolumab Docetaxel + Nivolumab + Ramucirumab | A Phase 1/2 Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV Non-small Cell Lung Cancer That Has Spread or Has Reoccurred After Failure of Chemotherapy and Immunotherapy | Withdrawn | USA | 12 |
| NCT03141177 | Phase III | Cabozantinib + Ipilimumab + Nivolumab Sunitinib Cabozantinib + Nivolumab | A Study of Nivolumab Combined With Cabozantinib or Nivolumab and Ipilimumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 9ER) | Active, not recruiting | USA | 17 |
| NCT03316586 | Phase II | Cabozantinib + Nivolumab | A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer | Active, not recruiting | USA | 0 |
| NCT04310007 | Phase II | Nab-paclitaxel Gemcitabine Cabozantinib + Nivolumab Cabozantinib Docetaxel Paclitaxel Docetaxel + Ramucirumab | Testing the Addition of the Pill Chemotherapy, Cabozantinib, to the Standard Immune Therapy Nivolumab Compared to Standard Chemotherapy for Non-small Cell Lung Cancer | Recruiting | USA | 0 |
| NCT03299946 | Phase I | Cabozantinib + Nivolumab | Feasibility and Efficacy of Neoadjuvant Cabozantinib Plus Nivolumab (CaboNivo) Followed by Definitive Resection for Patients With Locally Advanced Hepatocellular Carcinoma (HCC) | Active, not recruiting | USA | 0 |
| NCT04514484 | Phase I | Cabozantinib + Nivolumab | Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV | Recruiting | USA | 0 |
| NCT03937219 | Phase III | Cabozantinib + Nivolumab Ipilimumab + Nivolumab Cabozantinib + Ipilimumab + Nivolumab | Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (COSMIC-313) | Active, not recruiting | USA | CAN | 23 |
| NCT03468985 | Phase II | Cabozantinib + Nivolumab Cabozantinib + Ipilimumab + Nivolumab Nivolumab | Nivolumab, Cabozantinib S-Malate, and Ipilimumab in Treating Patients With Recurrent Stage IV Non-small Cell Lung Cancer | Active, not recruiting | USA | 0 |
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