NCT02625337

Study Comparing Pembrolizumab With Dual MAPK Pathway Inhibition Plus Pembrolizumab in Melanoma Patients

Phase 2 Study Comparing Pembrolizumab With Intermittent/Short-term Dual MAPK Pathway Inhibition Plus Pembrolizumab in Patients Harboring the BRAFV600 Mutation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 trial consisting of 24 patients receiving the combination of dabrafenib + trametinib + pembrolizumab in 3 different dosing schemes and 8 patients receiving pembrolizumab standard monotherapy. All patients start with pembrolizumab standard therapy for 6 weeks and will then be randomized to continue pembrolizumab monotherapy or to receive additional intermitted/short-term dabrafenib + trametinib. Stratification will be baseline LDH level and baseline PD-L1 expression.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Pembrolizumab
DRUG	Dabrafenib
DRUG	Trametinib
PROCEDURE	Biopsy	Biopsies will be taken during screening, before randomization, at week 8 (only arm 2-4) after 12 weeks, at week 18 and if PD.
PROCEDURE	Blood taking	Blood will be taken for PBMCs during screening (twice), before randomization, at weeks 12 at week 18 and if PD.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-06-01
• Completion: 2018-12-01
• First posted: 2015-12-09
• Last updated: 2017-09-15

Locations

1 site across 1 country: Netherlands