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

Titre officiel

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)

Sommaire:

L’objectif de cette étude est de déterminer l’innocuité de la bempegaldesleukine (bempeg) prise en association avec le nivolumab et l’axitinib (partie 1), puis d’évaluer l’efficacité de la triple association nivolumab, bempeg et axitinib chez les patients atteints d’un cancer du rein avancé ou qui s’est propagé, qui n’a jamais été traité (partie 2).

Description de l'essai

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)
Secondary Outcome:
  • 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)

Voir cet essai sur ClinicalTrials.gov

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