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Status: RecruitingPhase: Diagnosis: Cutaneous Skin CancerNCT ID: NCT01584648
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-277
This is a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy to dabrafenib administered with a trametinib placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive will be screened for eligibility. Subjects who have had prior systemic anti-cancer treatment in the advanced or metastatic setting will not be eligible although prior systemic treatment in the adjuvant setting will be allowed. Approximately 340 subjects will be randomized 1:1 (combination therapy: dabrafenib monotherapy). Subjects will be stratified by lactate dehydrogenase (LDH) level (> the upper limit of normal (ULN) versus less than or equal to the ULN) and BRAF mutation (V600E versus V600K). The primary endpoint is investigator-assessed, progression-free survival for subjects receiving the combination therapy compared with those receiving dabrafenib monotherapy. Subjects will be followed for overall survival; crossover will not be permitted.
Conducting Institutions: Massachusetts General Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center
Overall PI: Keith Flaherty, MD,
Massachusetts General Hospital
Site-responsible Investigators: Nageatte Ibrahim, MD,
Dana Farber Cancer Institute
Contacts: Massachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100Dana-Farber Cancer Institute:
Suzanne MacRae, 617-632-5906,