Conditions: Melanoma
Keywords: MEK inhibitor Cancer Metastatic Melanoma BRAF mutant metastatic melanoma GSK1120212
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 322
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: MEK inhibitor arm 2: Investigator Choice of DTIC or paclitaxel arm 3: MEK inhibitor after documented progression on Chemotherapy Arm

Interventions: intervention 1: GSK1120212 intervention 2: Chemotherapy
Intervention descriptions: intervention 1: MEK inhibitor intervention 2: Investigator Choice of DTIC or paclitaxel

Protocol document: