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Therapy Name Pembrolizumab + Regorafenib
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 150 PD-L1/PD-1 antibody 136 Keytruda (pembrolizumab) is an antibody against PD-1 that activates T-cell mediated anti-tumor immune response (PMID: 25977344). Keytruda (pembrolizumab) is approved in melanoma, SCLC, HNSCC, classical Hodgkin Lymphoma, PMBL, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous SCC, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-positive NSCLC, esophageal SCC, cervical cancer, HNSCC, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in pleural mesothelioma and non-sNSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in sNSCLC, with axitinib or lenvatinib in RCC, with lenvatinib in endometrial carcinoma that is not MSI-H or dMMR, with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive cervical cancer, with gemcitabine and cisplatin for biliary tract cancer, with chemoradiation for cervical cancer, with carboplatin and paclitaxel for endometrial carcinoma, with paclitaxel with or without bevacizumab for epithelial ovarian, Fallopian tube, and peritonium cancer (FDA.gov).
Regorafenib Stivarga BAY 73-4506 BRAF Inhibitor 26 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
NCT03657641 Phase Ib/II Pembrolizumab + Regorafenib Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer Active, not recruiting USA 0
NCT04777851 Phase III Pembrolizumab + Regorafenib Regorafenib-pembrolizumab vs. TACE/TARE in Intermediate Stage HCC Beyond Up-to-7 (REPLACE) Active, not recruiting USA | TUR | ROU | ITA | FRA | ESP | DEU | BEL 5
NCT06006923 Phase II Pembrolizumab Pembrolizumab + Regorafenib Regorafenib in Combination With Pembrolizumab or Pembrolizumab for MSI-H Colorectal Cancer Terminated USA 0
NCT04696055 Phase II Pembrolizumab + Regorafenib Pilot Study of Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors Completed USA | ITA | ISR | FRA | ESP | DEU 2
NCT03347292 Phase I Pembrolizumab + Regorafenib Regorafenib Plus Pembrolizumab in First Line Systemic Treatment of HCC Completed USA | DEU 0


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