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Therapy Name	ALKS 4230 + Pembrolizumab
Synonyms
Therapy Description	ALKS 4230 is a fusion protein of IL2 and IL2RA, which activates effector lymphocytes upon binding to intermediate affinity IL2 receptors to enhance cell death of tumor cells (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4088).

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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
ALKS 4230		RDB 1450\|Nemvaleukin alfa\|ALKS-4230\|ALKS4230\|RBD1450\|RBD-1450		ALKS 4230 is a fusion protein of IL2 and IL2RA, which activates effector lymphocytes upon binding to intermediate affinity IL2 receptors to enhance cell death of tumor cells (AACR; Cancer Res 2017;77(13 Suppl):Abstract nr 4088, PMID: 32317293).
Pembrolizumab	Keytruda	MK-3475	Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 129	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 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, 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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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT04592653	Phase Ib/II	ALKS 4230 ALKS 4230 + Pembrolizumab	Less Frequent IV Dosing & Tumor Microenvironment (TME) Study of Nemvaleukin Alfa (ALKS 4230) Monotherapy and in Combination With Pembrolizumab (ARTISTRY-3) (ARTISTRY-3)	Active, not recruiting	USA \| ESP	0
NCT05092360	Phase III	Pembrolizumab ALKS 4230 Topotecan Paclitaxel Pegylated liposomal doxorubicin Gemcitabine ALKS 4230 + Pembrolizumab	Phase 3 Study of Nemvaleukin Alfa in Combination With Pembrolizumab (ARTISTRY-7)	Active, not recruiting	USA \| ITA \| GBR \| FRA \| ESP \| DEU \| CZE \| CAN \| BEL \| AUT \| AUS	3
NCT03861793	Phase I	ALKS 4230 + Pembrolizumab ALKS 4230	A Dose Escalation and Cohort Expansion Study of Subcutaneously-Administered Cytokine (ALKS 4230) as a Single Agent and in Combination With Anti-PD-1 Antibody (Pembrolizumab) in Patients With Select Advanced or Metastatic Solid Tumors (ARTISTRY-2)	Completed	USA \| NLD \| ESP \| CAN	2
NCT04144517	Phase II	ALKS 4230 + Pembrolizumab	A Study of ALKS 4230 With Pembrolizumab in Head and Neck Cancer	Completed	USA	0

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