A Phase III, randomized, double-blinded study comparing the combination of the BRAF inhibitor, dabrafenib and the MEK inhibitor, trametinib to dabrafenib and placebo as first-line therapy in subjects with unresectable (Stage IIIc) or metastatic (Stage IV) BRAF V600E/K mutation-positive cutaneous melanoma (MEK115306)
Phase 3
Completed
- Conditions
- melanoma of the skin10040900
- Registration Number
- NL-OMON47344
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
* Subjects with histologically confirmed advanced or metastatic melanoma
* BRAF V600 E/K mutation positive.
* Measurable disease.
* 18 years and above.
* ECOG Performance Status 0-1.
* Females of childbearing potential: adequate method of contraception.
Exclusion Criteria
* Previous treatment for metastatic melanoma, including treatment with BRAF or MEK inhibitor.
* Prior systemic anti-cancer treatment for Stage IIIC or Stage IV melanoma.
* Brain metastases (exceptions see protocol page 26).
* Cardiovascular risk (see protocol page 26 for details).
* A history or current evidence/risk of retinal vein occlusion or central serous retinopathy.
* Pregnancy or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Progression free survival.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall survival, overall response rate, duration of response, safety,<br /><br>tolerability, PK.</p><br>