Clinical Trials Search
Clinical Trial 19474
Interventions:GSK1120212 (Trametinib); GSK2118436 (dabrafenib); PDR001; Placebo; Trametinib; dabrafenib
Study Type: Treatment
Phase of Study: Phase III
- Nikhil Khushalani
A Randomized, Double-Blind, Placebo-Controlled, Phase III Study Comparing the Combination of PDR001, Dabrafenib and Trametinib versus Placebo, Dabrafenib and Trametinib in Previously Untreated Patients with Unresectable or Metastatic BRAF V600 Mutant Melanoma
The purpose of this study is to evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma.
To determine the recommended regimen of PDR001 in combination with dabrafenib and trametinib for the randomized part. To evaluate changes in PD-L1 levels and CD8+ cells upon treatment with PDR001 in combination with dabrafenib and trametinib. To compare the anti-tumor activity of PDR001 in combination with dabrafenib and trametinib versus placebo plus dabrafenib and trametinib as measured by PFS per investigators assessment according to RECIST 1.1.