A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Titre officiel

A Phase 3, Randomized, Open-label Study of NKTR-214 Combined With Nivolumab Versus Nivolumab in Participants With Previously Untreated Unresectable or Metastatic Melanoma

Sommaire:

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

Description de l'essai

Primary Outcome:

  • Overall response rate (ORR) by Blinded Independent Central Review (BICR)
  • Progression-free survival (PFS) by BICR
  • Overall survival (OS)
Secondary Outcome:
  • Clinical benefit rate (CBR)
  • Duration of response (DoR)
  • Duration of overall complete response (DoCR)
  • Time to response (TTR)
  • ORR by investigator and in biomarker population
  • PFS by investigator and in biomarker population
  • OS in biomarker population
  • Incidence of participants with non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) leading to discontinuation
  • Incidence of treatment-related AEs
  • Incidence of treatment-related SAEs
  • Incidence of laboratory abnormalities

Voir cet essai sur ClinicalTrials.gov

Intéressé(e) par cet essai?

Imprimez cette page et apportez-la chez votre médecin pour discuter de votre admissibilité à cet essai et des options de traitement. Seul votre médecin peut vous recommander pour un essai clinique.

Ressources

Société canadienne du cancer

Ces ressources sont fournies en partenariat avec Société canadienne du cancer