|Phase III||Treatment||Closed||18 and over||Pharmaceutical / Industry||115306|
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.
- Histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV (metastatic), and determined to be BRAF V600E/K mutation-positive using the bioMerieux (bMx) investigational use only (IUO) THxID BRAF Assay (IDE: G120011). The assay will be conducted by a central reference laboratory. Subjects with ocular or mucosal melanoma are not eligible.
- The subject must have a radiologically measurable tumor
- The subject is able to carry out daily life activities without significant difficulty (ECOG performance status score of 0 or 1).
- Able to swallow and retain oral medication
- Sexually active subjects must use acceptable methods of contraception during the course of the study
- Adequate organ system function and blood counts
- Prior treatment with a BRAF or a MEK inhibitor
- Prior systemic anti-cancer treatment for Stage IIIC (unresectable) or Stage IV (metastatic) melanoma. Prior systemic treatment in the adjuvant setting is allowed. (Note: Ipilimumab treatment must end at least 8 weeks prior to randomization.)
- The subject has received major surgery or certain tyes of cancer therapy with 21 days of starting treatment
- Current use of prohibited medication listed in the protocol
- Left ventricular ejection fraction less than the lower limit of normal
- Uncontrolled blood pressurl
- History or current evidence of retinal vein occlusion or central serous retinopathy
- Brain metastases unless previously treated with surgery or stereotactic radiosurgery and the disease has been stable for at least 12 weeks
- The subject is pregnant or nursing
Trial Lead Organizations/Sponsors
|GSK Clinical Trials||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01584648
Information obtained from ClinicalTrials.gov on April 29, 2013
Back to Top