Therapy Detail

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Therapy Name Azacitidine + Pembrolizumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Azacitidine Vidaza azacytidine|CC-486|5-azacytidine|5-AC|U-18496|Onureg DNMT inhibitor (Pan) 5 Vidaza (azacitidine) is a cytidine analog that incorporates into DNA and RNA and binds to DNA methyltransferases (DNMTs), resulting in DNMT degradation and decreased DNA methylation, and leading to increased tumor cell death (PMID: 28159832, PMID: 28067760). Vidaza (azacitidine) is FDA-approved for use in patients with some subtypes of myelodysplastic syndrome and Onureg (azacitidine) is FDA approved for use in continued treatment of acute myeloid leukemia(FDA.gov).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 148 PD-L1/PD-1 antibody 117 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, and TNBC, in combination with platnum-based chemo in NSCLC, with pemetrexed and platinum in 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, in combination with platinum and fluoropyrimidine-based chemo for esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemo for CD274 (PD-L1)-positive, HER2-positive gastric or GEJ adenocarcinoma, in combination with fluoropyrimidine- and platinum-containing chemo for HER2-negative gastric or GEJ adenocarcinoma, in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-positive (CPS>=1) cervical cancer, in combination with gemcitabine and cisplatin for biliary tract cancer, in combination with chemoradiation for cervical cancer, and in combination with carboplatin and paclitaxel for endometrial carcinoma (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
NCT02845297 Phase II Azacitidine + Pembrolizumab Phase 2 Study of Azacitidine in Combination With Pembrolizumab in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients and in Newly Diagnosed Older (?65 Years) AML Patients Completed USA 0
NCT03264404 Phase II Azacitidine + Pembrolizumab Azacitidine and Pembrolizumab in Pancreatic Cancer Active, not recruiting USA 0
NCT02546986 Phase II Azacitidine + Pembrolizumab Pembrolizumab Safety and Efficacy Study of CC-486 With MK-3475 to Treat Locally Advanced or Metastatic Non-small Cell Lung Cancer Active, not recruiting USA | ITA | FRA | ESP | DEU 1
NCT03094637 Phase II Azacitidine + Pembrolizumab Azacitidine and Pembrolizumab for Patients With Myelodysplastic Syndrome (MDS) Active, not recruiting USA 0
NCT05355051 Phase II Azacitidine + Pembrolizumab A Phase II Study of the Combination of Azacitidine and Pembrolizumab for Patients Relapsed/Refractory Hodgkin's Lymphoma Recruiting USA 0
NCT02260440 Phase II Azacitidine + Pembrolizumab A Phase 2 Study of MK-3475 in Combination With Azacitidine in Subjects With Chemo-refractory Metastatic Colorectal Cancer Completed USA 0
NCT02900560 Phase II Azacitidine + Pembrolizumab Study of Pembrolizumab With or Without CC-486 in Patients With Platinum-resistant Ovarian Cancer Terminated USA 0
NCT02816021 Phase II Azacitidine + Pembrolizumab Study of Oral Azacitidine (CC-486) in Combination With Pembrolizumab (MK-3475) in Patients With Metastatic Melanoma Active, not recruiting USA 0
NCT02512172 Phase I Azacitidine + Pembrolizumab Pembrolizumab + Romidepsin Azacitidine + Pembrolizumab + Romidepsin A Study of Enhancing Response to MK-3475 in Advanced Colorectal Cancer Completed USA 0


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