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Therapy Name | ALT-803 + Pembrolizumab |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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ALT-803 | N-803|N803|N 803|nogapendekin alfa|ALT803|ALT 803 | ALT-803 (nogapendekin alfa) is a fusion protein comprising a mutant version of IL-15 with increased activity and IL-15Ra fused to the Fc region of IgG1, which activates CD8+ T-cells and promotes effector activity, potentially resulting in increased antitumor immune response (PMID: 24404427, PMID: 31338557). | ||
Pembrolizumab | Keytruda | MK-3475 | Immune Checkpoint Inhibitor 155 PD-L1/PD-1 antibody 105 | 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 |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT03520686 | Phase III | ALT-803 + Carboplatin + Pembrolizumab + Pemetrexed Disodium ALT-803 + Cisplatin + Pembrolizumab + Pemetrexed Disodium Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab ALT-803 + Pembrolizumab Carboplatin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium ALT-803 + Carboplatin + Nab-paclitaxel + Pembrolizumab | QUILT 2.023: A Study of N-803 in Combination With Current Standard of Care vs Standard of Care as First-Line Treatment for Patients With Stage 3 or 4 NSCLC. | Active, not recruiting | USA | 0 |
NCT03228667 | Phase II | ALT-803 + Nivolumab ALT-803 + Pembrolizumab | QUILT-3.055: A Phase IIb, Single-Arm, Open-Label Study of ALT-803 in Combination With Pembrolizumab or Nivolumab in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Disease Progression Following an Initial Response to Treatment With PD-1 Checkpoint Inhibitor Therapy | Active, not recruiting | USA | 0 |
NCT05096663 | Phase II | Dexamethasone + Docetaxel + Gemcitabine + Pemetrexed Disodium + Ramucirumab ALT-803 + Pembrolizumab | Testing the Use of Combination Immunotherapy Treatment (N-803 [ALT-803] Plus Pembrolizumab) Against the Usual Treatment for Advanced Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) | Active, not recruiting | USA | 0 |