Therapy Detail
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| Therapy Name | Nivolumab + Regorafenib |
| 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 149 PD-L1/PD-1 antibody 121 | 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). |
| Regorafenib | Stivarga | BAY 73-4506 | BRAF Inhibitor 25 CRAF Inhibitor 12 KIT Inhibitor 57 PDGFR Inhibitor (Pan) 30 RET Inhibitor 53 VEGFR Inhibitor (Pan) 36 VEGFR2 Inhibitor 37 | Stivarga (regorafenib) is an inhibitor of several kinases including VEGFR, RET, KIT, PDGFR and RAF, thereby inhibiting tumor angiogenesis and tumor cell proliferation (PMID: 24756792). Stivarga (regorafenib) is FDA approved for colorectal cancer, hepatocellular carcinoma, and GIST (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 |
|---|---|---|---|---|---|---|
| NCT04803877 | Phase II | Nivolumab + Regorafenib | SARC038: Phase 2 Study of Regorafenib and Nivolumab in Osteosarcoma | Active, not recruiting | USA | 0 |
| NCT04170556 | Phase Ib/II | Nivolumab + Regorafenib | Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma (GOING) (GOING) | Completed | ESP | 0 |
| NCT04126733 | Phase II | Nivolumab + Regorafenib | Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable) | Completed | USA | 0 |
| NCT04704154 | Phase II | Nivolumab + Regorafenib | A Trial to Learn Whether Regorafenib in Combination With Nivolumab Can Improve Tumor Responses and How Safe it is for Participants With Solid Tumors | Completed | USA | ITA | GBR | FRA | BEL | 3 |
| NCT04503694 | Phase II | Nivolumab + Regorafenib | Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Intermediate-risk, Stage II-III Rectal Cancer (REGINA) | Recruiting | BEL | 0 |
| NCT04879368 | Phase III | Docetaxel Paclitaxel Trifluridine-tipiracil hydrochloride Nivolumab + Regorafenib Irinotecan | RegoNivo vs Standard of Care Chemotherapy in AGOC (INTEGRATEIIb) | Active, not recruiting | USA | ITA | ESP | DEU | AUT | AUS | 3 |
| NCT03712943 | Phase I | Nivolumab + Regorafenib | Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer | Completed | USA | 0 |
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