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

Phase 3

Active, not recruiting

• Conditions: Malignant Melanoma; Cancer - Malignant melanoma

• Registration Number: ACTRN12612001034820
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 340

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 pressure

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified