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 64 KIT Inhibitor 56 MET Inhibitor 58 RET Inhibitor 52 ROS1 Inhibitor 20 VEGFR2 Inhibitor 37 | 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, adult and pediatric patients 12 years and older with locally advanced or metastatic differentiated thyroid cancer, and in combination with Opdivo (nivolumab) in patients with advanced renal cell carcinoma (FDA.gov). |
| Nivolumab | Opdivo | MDX-1106|BMS-936558|ABP 206|ABP-206 | Immune Checkpoint Inhibitor 146 PD-L1/PD-1 antibody 109 | 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). |
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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 |
|---|---|---|---|---|---|---|
| NCT05039736 | Phase II | Cabozantinib + Nivolumab | A Phase II Study to Evaluate the Effects of Sequential Therapy With the Anti c-MET/VEGFR Tyrosine Kinase Inhibitor (TKI), Cabozantinib, Followed by an Anti-PD-1 Antibody (Nivolumab) in Patients With Advanced HCC Who Progressed on First-line Therapy | Withdrawn | 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 |
| 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) | Completed | USA | 0 |
| NCT03635892 | Phase II | Cabozantinib + Nivolumab | A Study of Nivolumab In Combination With Cabozantinib in Patients With Non-Clear Cell Renal Cell Carcinoma | Active, not recruiting | USA | 0 |
| 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 | Completed | USA | 0 |
| NCT03866382 | Phase II | Cabozantinib + Nivolumab Cabozantinib + Ipilimumab + Nivolumab | Cabozantinib in Combination With Nivolumab and Ipilimumab in Rare Genitourinary Tumors | Recruiting | USA | 1 |
| 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 | Active, not recruiting | USA | 0 |
| NCT04197310 | Phase II | Cabozantinib + Nivolumab | Cabozantinib and Nivolumab for Carcinoid Tumors | Active, not recruiting | USA | 0 |
| NCT03316586 | Phase II | Cabozantinib + Nivolumab | A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer | Completed | USA | 0 |
| NCT05136196 | Phase II | Cabozantinib + Nivolumab | BiCaZO: A Study Combining Two Immunotherapies (Cabozantinib and Nivolumab) to Treat Patients With Advanced Melanoma or Squamous Cell Head and Neck Cancer, an immunoMATCH Pilot Study | Suspended | USA | 0 |
| NCT05327686 | Phase II | Axitinib + Pembrolizumab Lenvatinib + Pembrolizumab Ipilimumab + Nivolumab Avelumab + Axitinib Cabozantinib + Nivolumab | Testing the Addition of Stereotactic Radiation Therapy With Immune Therapy for the Treatment of Patients With Unresectable or Metastatic Renal Cell Cancer, SAMURAI Study (SAMURAI) | Recruiting | USA | 0 |
| NCT05931393 | Phase II | Cabozantinib + Nivolumab Cabozantinib | Sequential Treatment of Cabozantinib or Cabozantinib With Nivolumab for Advanced Renal Cell Carcinoma (RCC) | Not yet recruiting | USA | 0 |
| NCT04339738 | Phase II | Cabozantinib + Nivolumab Nivolumab + Paclitaxel Paclitaxel | Testing the Addition of Nivolumab to Chemotherapy in Treatment of Soft Tissue Sarcoma | Active, not recruiting | USA | 1 |
| NCT04963283 | Phase II | Cabozantinib + Nivolumab | Study of Cabozantinib and Nivolumab in Refractory Metastatic Microsatellite Stable (MSS) Colorectal Cancer | 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 |
| NCT04091750 | Phase II | Cabozantinib + Ipilimumab + Nivolumab Cabozantinib + Nivolumab | Nivolumab/Ipilimumab Plus Cabozantinib in Patients With Unresectable Advanced Melanoma | Suspended | 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 |
| NCT05122546 | Phase I | Cabozantinib + Nivolumab Cabozantinib + CBM588 + Nivolumab | CBM588 in Combination With Nivolumab and Cabozantinib for the Treatment of Advanced or Metastatic Kidney Cancer | Active, not 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 |
| 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 | BEL | 8 |
| NCT05111574 | Phase II | Nivolumab Cabozantinib + Nivolumab | Using Nivolumab Alone or With Cabozantinib to Prevent Mucosal Melanoma Return After Surgery | Recruiting | USA | CAN | 0 |
| NCT05361720 | Phase II | Cabozantinib + Nivolumab Ipilimumab + Nivolumab | Genetic Testing to Select Therapy for the Treatment of Advanced or Metastatic Kidney Cancer, OPTIC RCC Study | 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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 15 |
| NCT05502315 | Phase II | Cabozantinib + Nivolumab | Study of Cabozantinib and Nivolumab in Metastatic Castration Resistant Prostate Cancer (CANOPY) | 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 |
| 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 | ITA | GBR | ESP | DEU | AUS | 12 |
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