NCT04835805

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 nivolumab in patients with NRAS-mutant advanced melanoma who have received anti-PD-1/PD-L1 therapy.

Detailed description

The study will evaluate three treatment regimens in three arms: a belvarafenib monotherapy arm (Belva arm); 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 nivolumab arm (Belva + Cobi + Nivo arm) in a run-in phase followed by an expansion phase.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	Belvarafenib	Twice daily (BID), continuous dosing
DRUG	Cobimetinib	Once daily (QD) or three times weekly (TIW) for 21 days, 7 days off
DRUG	Nivolumab	Once every 4 weeks (Q4W)

Timeline

• Start date: 2021-05-13
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2021-04-08
• Last updated: 2026-03-30

Locations

17 sites across 5 countries: United States, Australia, Canada, Germany, South Korea

Regulatory

• FDA-regulated drug study