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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 bebempegaldesleukin (NKTR-214) combined with nivolumab to that of tyrosine kinase inhibitor (TKI) monotherapy (sunitinib)

Acronym:

PIVOT9

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)

Sponsor / Cooperative group:

Nektar Therapeutics

Trial & Patient Characteristics

Cancer TypeKidney
Trial TypeTreatment
PhasePhase III
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageAll stages
Anticipated Start Date2018-12-03
Anticipated End Date2024-06-01

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Francis Parnis
Recruitment StatusRecruiting