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.

Official Title

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

Summary:

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.

Trial Description

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.

View this trial on ClinicalTrials.gov

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society