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 135 PD-L1/PD-1 antibody 79 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, 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 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, 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).

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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
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 19
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
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 16
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
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
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
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
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 16


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