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|Therapy Name||ALKS 4230 + Pembrolizumab|
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).
|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 154 PD-L1/PD-1 antibody 106||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, primary mediastinal large B-cell lymphoma, urothelial carcinoma, HCC, Merkel cell carcinoma, NMIBC, cutaneous squamous cell carcinoma, MSI-H or dMMR or TMB high advanced solid tumors, NSCLC and CD274 (PD-L1)-expressing NSCLC, gastric and GEJ adenocarcinoma, squamous esophageal carcinoma, cervical cancer, and triple-negative breast cancer, in combination with pemetrexed and platinum in non-squamous NSCLC with no EGFR or ALK mutations, with carboplatin and paclitaxel/nab-paclitaxel in squamous NSCLC, 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 chemotherapy for patients with esophageal or gastroesophageal carcinoma, in combination with Herceptin (trastuzumab), fluoropyrimidine- and platinum-containing chemotherapy for first-line treatment of patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma, and in combination with platinum-based chemotherapy, with or without bevacizumab, for patients with CD274 (PD-L1)-expressing (CPS>=1) cervical cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status||Covered Countries||Other Countries|
|NCT04144517||Phase II||ALKS 4230 + Pembrolizumab||A Study of ALKS 4230 With Pembrolizumab in Head and Neck Cancer||Completed||USA||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)||Recruiting||USA | ITA | GBR | ESP | CAN | AUT | AUS||2|
|NCT04592653||Phase II||ALKS 4230 + Pembrolizumab||A Study of ALKS 4230 on the Tumor Microenvironment (ARTISTRY-3)||Recruiting||USA||0|
|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)||Active, not recruiting||USA | ESP | CAN||3|