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