Study to Investigate the Objective Response Rate of Dabrafenib in Combination With Trametinib in Subjects With BRAF V600 Mutation-Positive Melanoma

• Status: Completed
• Trial end date: 2021-04-19

Summary

This is a single-arm, open-label, multi-center, Phase II study to evaluate dabrafenib and trametinib combination therapy in subjects with BRAF V600 mutation-positive, unresectable or metastatic Acral lentiginous or cutaneous melanoma. This study will evaluate the objective response rate (ORR), progression free survival (PFS), duration of response, overall survival (OS), safety and efficacy, to assess steady state (all subjects) exposure to dabrafenib, dabrafenib metabolites, and trametinib and characterize the population pharmacokinetics (PK) and pharmacodynamics (PD) of dabrafenib and trametinib. Subjects will be enrolled and will receive dabrafenib 150 milligram (mg) orally twice daily and trametinib 2 mg orally once daily. Treatment will continue until disease progression, death, unacceptable toxicity, or withdrawal of consent, or study closure. After treatment discontinuation, subjects will be followed for survival and disease progression as applicable.

• Phase: Phase 2

Details

• Lead Sponsor: GlaxoSmithKline; Novartis Pharmaceuticals
• Treatments: Dabrafenib; Trametinib