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Therapy Name | Nivolumab + Nogapendekin alfa inbakicept |
Synonyms | |
Therapy Description | |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Nivolumab | Opdivo | MDX-1106|BMS-936558 | Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 121 | Opdivo (nivolumab) is an antibody that targets PD-1 (PDCD1), which results in increased T-cell activation and enhanced anti-tumor immune response (PMID: 28891423). Opdivo (nivolumab) is FDA approved for use as a monotherapy in patients with non-small cell lung cancer (NSCLC) progressed on prior therapies, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma (UC) , esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) for melanoma, renal cell carcinoma (RCC), microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (including patients 12 years or older), and hepatocellular carcinoma, in combination with Yervoy (ipilimumab) as first-line therapy for PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy for metastatic or recurrent NSCLC without EGFR or ALK alterations, with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, with Cabometyx (cabozantinib) for advanced RCC, with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, and with cisplatin and gemcitabine as first-line treatment for unresectable or metastatic UC (FDA.gov). |
Nogapendekin alfa inbakicept | Anktiva | N-803|N803|N 803|nogapendekin alfa|ALT803|ALT 803|ALT-803 | Anktiva (nogapendekin alfa inbakicept) 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). Anktiva (nogapendekin alfa inbakicept) in combination with BCG is FDA approved for use in patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors (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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NCT03228667 | Phase II | Nivolumab + Nogapendekin alfa inbakicept Nogapendekin alfa inbakicept + 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 |
NCT02523469 | Phase Ib/II | Nivolumab + Nogapendekin alfa inbakicept | ALT-803 Plus Nivolumab in Patients With Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer | Completed | USA | 0 |