A Study to Evaluate the Triplet Combination of Bempegaldesleukin (Bempeg/NKTR-214) Plus Nivolumab and Axitinib and the Doublet Combination of Nivolumab and Axitinib in Participants With Previously Untreated Kidney Cancer That is Advanced or Has Spread

Official Title

A Phase 1/2 Study to Evaluate the Triplet Combination of NKTR-214 Plus Nivolumab and Axitinib and the Doublet Combination of Nivolumab and Axitinib in Participants With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (mRCC) (PIVOT IO 011)

Summary:

The purpose of this study is to determine the safety of bempegaldesleukin combined with nivolumab and axitinib (Part 1), and then to evaluate the effectiveness of the nivolumab, bempeg, and axitinib triplet regimen in participants with previously untreated kidney cancer that has advanced or has spread (Part 2).

Trial Description

Primary Outcome:

• Incidence of adverse events (AEs) by severity (Part 1)
• Incidence of serious adverse events (SAEs) (Part 1)
• Incidence of AEs leading to discontinuation (Part 1)
• Incidence of immune-mediated adverse events (imAEs) (Part 1)
• Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 1)
• Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 1)
• Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 1)
• Overall response rate (ORR) by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 by Investigator assessment (Part 2)

• Progression-free survival (PFS) by RECIST 1.1 by Investigator assessment (Part 2)
• Overall survival (OS) (Part 2)
• Incidence of AEs by severity (Part 2)
• Incidence of SAEs (Part 2)
• Incidence of AEs leading to discontinuation (Part 2)
• Incidence of imAEs (Part 2)
• Incidence of changes in clinical laboratory results by severity: Hematology tests (Part 2)
• Incidence of changes in clinical laboratory results by severity: Clinical Chemistry tests (Part 2)
• Incidence of changes in clinical laboratory results by severity: Urinalysis tests (Part 2)

View this trial on ClinicalTrials.gov