GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
Status:
Completed
Trial end date:
2016-12-16
Target enrollment:
Participant gender:
Summary
This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212
to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV
malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample.
Subjects who have received up to one prior regimen of chemotherapy in the advanced or
metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or
MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1
randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy
arm). The primary endpoint for the statistical analysis will be a comparison of progression
free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have
progression on chemotherapy will be offered the option to receive GSK1120212.