NCT02416232.
Study name | An open label non randomized access study of trametinib for patients with advanced unresectable (stage IIIc) or distant metastatic (stage IV) BRAF V600E/K mutation positive cutaneous melanoma. |
Methods | Phase III non‐RCT. |
Participants | Metastatic melanoma with brain metastasis. Estimated enrolment: 250. |
Interventions | Single arm study: participants will receive trametinib 2 mg orally once daily and, where appropriate, in combination with dabrafenib 150 mg orally twice daily. |
Outcomes |
Primary outcomes:
|
Starting date | March 2015. |
Contact information | USA GSK Clinical Trials Call Center, GSKClinicalSupportHD@gsk.com |
Notes | ‐ |