NCT03729245

A Study of Bempegaldesleukin (NKTR-214: BEMPEG) 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)

A Phase 3 Randomized Open Label Study to Compare NKTR-214 Combined With Nivolumab to the Investigator's Choice of Sunitinib or Cabozantinib in Patients With Previously Untreated Advanced Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 623 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to compare the objective response rate (ORR) and overall survival (OS) of bempegaldesleukin (NKTR-214: BEMPEG) 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).

Conditions

• Renal Cell Carcinoma
• Metastatic Renal Cell Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	bempegaldesleukin	Specified dose on specified days
DRUG	sunitinib	Specified dose on specified days
BIOLOGICAL	nivolumab	Specified dose on specified days
DRUG	cabozantinib	Specified dose on specified days

Timeline

• Start date: 2018-12-18
• Primary completion: 2022-01-07
• Completion: 2022-10-19
• First posted: 2018-11-02
• Last updated: 2023-04-11
• Results posted: 2023-04-11

Locations

96 sites across 10 countries: United States, Argentina, Australia, Brazil, Chile, Mexico, New Zealand, Peru, Russia, Singapore

Regulatory

• FDA-regulated drug study