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|Therapy Name||Nivolumab + NKTR-214|
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|NKTR-214||Bempegaldesleukin|Bempeg||Bempegaldesleukin (NKTR-214) comprises IL2 bound to polyethylene glycol, which stimulates anti-tumor immune response, potentially resulting in decreased tumor growth (PMID: 26832745, PMID: 32723187).|
|Nivolumab||Opdivo||MDX-1106|BMS-936558||Immune Checkpoint Inhibitor 149 PD-L1/PD-1 antibody 95||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, esophageal squamous cell carcinoma, resected esophageal or gastroesophageal junction (GEJ) cancer, as a monotherapy or in combination with Yervoy (ipilimumab) in patients with melanoma, renal cell carcinoma, 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 in patients with PD-L1-positive (>=1%) metastatic NSCLC without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent NSCLC without EGFR or ALK alterations, in combination with platinum doublet chemotherapy as neoadjuvant treatment for patients with resectable NSCLC, in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma, and in combination with fluoropyrimidine- and platinum-containing chemotherapy in patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (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|
|NCT03835533||Phase I||CDX-301 + INO-5151 + Nivolumab CDX-301 + Nivolumab + Poly ICLC Nivolumab + NKTR-214||Platform Study for Prostate Researching Translational Endpoints Correlated to Response to Inform Use of Novel Combinations (PORTER)||Completed||USA||0|
|NCT03785925||Phase II||Nivolumab + NKTR-214||A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer (PIVOT-10)||Completed||USA | ITA | FRA | ESP | DEU | CAN | BEL||11|
|NCT05176483||Phase I||Nivolumab + NKTR-214 XL092 Nivolumab + NKTR-214 + XL092 Ipilimumab + Nivolumab + XL092 Nivolumab + XL092 Ipilimumab + Nivolumab||Study of XL092 in Combination With Immuno-Oncology Agents in Subjects With Solid Tumors (STELLAR-002)||Recruiting||USA||0|
|NCT03635983||Phase III||Nivolumab Nivolumab + NKTR-214||A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma||Active, not recruiting||USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT||19|
|NCT03282344||Phase II||Nivolumab + NKTR-214||A Study of NKTR-214 in Combination With Nivolumab in Patients With Metastatic and/or Locally Advanced Sarcoma||Active, not recruiting||USA||0|
|NCT04410445||Phase III||Nivolumab Nivolumab + NKTR-214||Study to Compare Adjuvant Immunotherapy of Bempegaldesleukin Combined With Nivolumab Versus Nivolumab After Complete Resection of Melanoma in Patients at High Risk for Recurrence (PIVOT-12)||Terminated||USA | ITA | FRA | ESP | DEU | AUT||11|
|NCT04209114||Phase III||Nivolumab + NKTR-214 Nivolumab||A Study of Nivolumab Plus NKTR-214 vs Nivolumab Alone vs Standard of Care in Participants With Bladder Cancer That Has Invaded the Muscle Wall of the Bladder and Who Cannot Get Cisplatin, a Type of Medicine Given to Treat Bladder Cancer.||Active, not recruiting||USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT||12|
|NCT04730349||Phase Ib/II||Nivolumab + NKTR-214||A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer (PIVOT IO 020)||Completed||USA | ITA | FRA | ESP | DEU||1|
|NCT02983045||Phase Ib/II||Nivolumab + NKTR-214||A Dose Escalation and Cohort Expansion Study of CD122-Biased Cytokine (NKTR-214) in Combination With Anti-PD-1 Antibody (Nivolumab) in Patients With Select Advanced or Metastatic Solid Tumors (PIVOT-02)||Completed||USA | ITA | FRA | ESP | CAN | BEL||2|
|NCT03729245||Phase III||Cabozantinib + Sunitinib Nivolumab + NKTR-214||A Study of NKTR-214 in Combination With Nivolumab Compared With the Investigator's Choice of a Tyrosine Kinase Inhibitor (TKI) Therapy (Either Sunitinib or Cabozantinib Monotherapy) for Advanced Metastatic Renal Cell Carcinoma (RCC)||Terminated||USA||10|