A Study to Evaluate the Safety and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Atezolizumab in Patients With NRAS-mutant Advanced Melanoma.

Titre officiel

A Phase Ib, Open-Label, Multicentre Study to Evaluate the Safety, Pharmacokinetics, and Activity of Belvarafenib as a Single Agent and in Combination With Either Cobimetinib or Cobimetinib Plus Atezolizumab in Patients With NRAS-Mutant Advanced Melanoma Who Have Received Anti-PD-1/PD-L1 Therapy

Sommaire:

This study will evaluate the safety, pharmacokinetics, and activity of belvarafenib as a single agent and in combination with either cobimetinib or cobimetinib plus atezolizumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

Description de l'essai

Primary Outcome:

  • Percentage of Participants With Dose Limiting Toxicity (DLTs)
  • Percentage of Participants With Adverse Events
Secondary Outcome:
  • Objective response rate (ORR) according to RECIST v1.1
  • Progression free survival (PFS) according to RECIST v1.1
  • Duration of response (DOR) according to RECIST v1.1
  • Overall survival (OS)
  • Plasma concentration of belvarafenib at specified timepoints
  • Plasma concentration of cobimetinib at specified timepoints
  • Serum concentration of atezolizumab at specified timepoints
  • Concentration of atezolizumab anti-drug antibody (ADA)
The study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (Belva arm) of up to 15 patients; a belvarafenib plus cobimetinib arm (Belva + Cobi arm) in an initial dose-finding phase followed by an expansion phase and a belvarafenib plus cobimetinib plus atezolizumab arm (Belva + Cobi + Atezo arm) in a run-in phase followed by an expansion phase.

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