Therapy Detail

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Therapy Name Nivolumab + NKTR-214
Synonyms
Therapy Description

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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 98 PD-L1/PD-1 antibody 67 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, small cell lung cancer, Hodgkin's lymphoma, head and neck squamous cell carcinoma, urothelial carcinoma, and esophageal squamous cell carcinoma, 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 non-small cell lung cancer without EGFR or ALK alterations, in combination with Yervoy (ipilimumab) and platinum-based chemotherapy as first-line therapy in patients with metastatic or recurrent non-small cell lung cancer without EGFR or ALK alterations, and in combination with Cabometyx (cabozantinib) in patients with advanced renal cell carcinoma (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
Unknown unknown melanoma not applicable Nivolumab + NKTR-214 Phase Ib/II Actionable In a Phase I/II trial, NKTR-214 and Opdivo (nivolumab) combination treatment demonstrated safety and preliminary efficacy, resulted in radiographic response in one and complete response in another patient with melanoma (Journal of Clinical Oncology 35, no. 15_suppl; NCT02983045). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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) Active, not recruiting USA | CAN 6
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
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) 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) Recruiting USA 14
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) Not yet recruiting USA 4
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) Active, not recruiting USA 10
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. Recruiting USA | CAN 18
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 Recruiting USA | CAN 25
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) Active, not recruiting USA | CAN 19


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