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 147 PD-L1/PD-1 antibody 117 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).

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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
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 | NZL | AUS 7
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 Completed USA | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 15
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 | GBR | FRA | ESP | CAN | BEL 1
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
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. Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 9
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 | NZL | NLD | ITA | GBR | FRA | ESP | DEU | AUT | AUS 7
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 | NZL | ITA | GBR | FRA | ESP | DEU | BEL | AUT | AUS 3
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) Terminated USA | ITA | FRA | ESP | DEU | AUS 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) 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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 8


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