A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma

• Status: Completed
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

Summary

This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline; Novartis Pharmaceuticals
• Treatments: Dabrafenib; Trametinib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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