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 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).
Regorafenib Stivarga BAY 73-4506 BRAF Inhibitor 21 CRAF Inhibitor 11 KIT Inhibitor 53 PDGFR Inhibitor (Pan) 27 RET Inhibitor 45 VEGFR Inhibitor (Pan) 33 VEGFR2 Inhibitor 35 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 Recruiting USA 0
NCT04503694 Phase II Nivolumab + Regorafenib Neoadjuvant Regorafenib in Combination With Nivolumab and Short-course Radiotherapy in Intermediate-risk, Stage II-III Rectal Cancer (REGINA) Active, not recruiting BEL 0
NCT04879368 Phase III Docetaxel Paclitaxel Trifluridine-tipiracil hydrochloride Nivolumab + Regorafenib Irinotecan RegoNivo vs Standard of Care Chemotherapy in AGOC (INTEGRATEIIb) Recruiting USA | CAN 5
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 Active, not recruiting USA | ITA | FRA | BEL 4
NCT03712943 Phase I Nivolumab + Regorafenib Regorafenib and Nivolumab in Mismatch Repair (MMR) Refractory Colorectal Cancer Active, not recruiting USA 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
NCT04170556 Phase Ib/II Nivolumab + Regorafenib Regorafenib Followed by Nivolumab in Patients With Hepatocellular Carcinoma (GOING) (GOING) Recruiting ESP 0


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