A Study of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Participants With Previously Untreated Advanced BRAFv600 Wild-Type Melanoma

Titre officiel

A Phase III, Open-Label, Multicentre, Two Arm, Randomized Study to Investigate the Efficacy and Safety of Cobimetinib Plus Atezolizumab Versus Pembrolizumab in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

Sommaire:

This is a Phase III, multicentre, open-label, randomized study designed to evaluate the efficacy, safety, and pharmacokinetics of cobimetinib plus atezolizumab compared with pembrolizumab in treatment-naive participants with advanced BRAFV600 wild-type melanoma.

Description de l'essai

Primary Outcome:

  • Progression Free Survival (PFS) as Determined by the Independent Review Committee (IRC)
Secondary Outcome:
  • PFS as Determined by the Investigator
  • Objective Response determined by the IRC
  • Objective Response Rate determined by the Investigator
  • Disease Control Rate (DCR)
  • Overall Survival (OS)
  • Duration of objective response determined by the IRC
  • Duration of Objective Response determined by the Investigator
  • Two-year Landmark Survival
  • Change From Baseline in Health-related Quality of Life (HRQoL) Scores
  • Number of Participants with Adverse Events (AEs)
  • Number of Participants With Abnormal Vital Signs
  • Number of Participants With Laboratory Abnormalities
  • Plasma Concentration of Cobimetinib
  • Serum Concentration of Atezolizumab
  • Percentage of Participants with Anti-drug Antibodies (ADAs)

Voir cet essai sur ClinicalTrials.gov

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