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  • CA045002/17-214-09

    Acronym: 

    CA045002

    ACTRN/NCT /ethics: 

    NCT03729245

    Scientific title: 

    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)

    Summary of trial and patient characteristics

    Cancer Type Kidney
    Trial Type Treatment
    Phase Phase III Tumour Stream Renal cell carcinoma
    Age Range 18 years and older Cancer Stage All stages
    Sex Both Anticipated Start Date 2018-12-18
    Molecular Target Anticipated End Date 2024-06-01
    Cancer Type Kidney
    Trial Type Treatment
    Phase Phase III
    Age Range 18 years and older
    Sex Both
    Molecular Target
    Tumour Stream Renal cell carcinoma
    Cancer Stage All stages
    Anticipated Start Date 2018-12-18
    Anticipated End Date 2024-06-01

    Trial Summary

    The main purpose of this phase-3 randomized open-label study is to compare the overall response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib or cabozantinib) in IMDC intermediate- or poor-risk patients and IMDC all-risk patients with previously untreated advanced renal cell carcinoma (RCC).

    Lay Summary

    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)

    Sponsor / Cooperative group

    Nektar Therapeutics

    Participating Hospitals

    Hospital Clinical Trial Coordinator Email Phone Principal Investigator Recruitment Status
    Ashford Cancer Centre Research Sue Yeend syeend@adelaidecancercentre.com.au 08 8292 2240 Recruiting