Therapy Detail

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Therapy Name Nogapendekin alfa inbakicept + Pembrolizumab
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
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).
Pembrolizumab Keytruda MK-3475 Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 122 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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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
NCT05096663 Phase II Dexamethasone + Docetaxel + Gemcitabine + Pemetrexed Disodium + Ramucirumab Nogapendekin alfa inbakicept + 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
NCT03520686 Phase III Carboplatin + Nogapendekin alfa inbakicept + Pembrolizumab + Pemetrexed Disodium Cisplatin + Nogapendekin alfa inbakicept + Pembrolizumab + Pemetrexed Disodium Pembrolizumab Carboplatin + Paclitaxel + Pembrolizumab Carboplatin + Nab-paclitaxel + Pembrolizumab Nogapendekin alfa inbakicept + Pembrolizumab Carboplatin + Pembrolizumab + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Nab-paclitaxel + Nogapendekin alfa inbakicept + 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 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
NCT06161545 Phase II Nogapendekin alfa inbakicept + PD-L1.t-haNK cells + Pembrolizumab Nogapendekin alfa inbakicept + Pembrolizumab Pembrolizumab + N-803 Alone or in Combination With PD-L1 t-haNK Cells for Resectable Head and Neck Squamous Cell Carcinoma Not yet recruiting USA 0


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