Clinical Trial VICCMEL1230
Title
MEK116513: A Phase III, Randomised, Open-Label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects with Unresectable (Stage IIIc) or metastatic (stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma
Principal Investigator(s)
Details
- Protocol No. VICCMEL1230
- Open Date: 09/19/2012
- Staging: Phase III
- Age Group: Adults
- Scope: National
- Objective: To establish the superiority of dabrafenib and trametinib combination therapy with vemurafenib monotherapy with respect to overall survival (OS) for subjects with advanced/metastatic BRAF V600E/K mutation-positive cutaneous melanoma.
- Disease Sites: Melanoma
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Dabrafenib; PLX4032; RO5185426 (Vemurafenib); Trametinib; Vemurafenib
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT01584648
- Secondary Protocol No: MEK116513
Description
None Provided.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
|---|---|
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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