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 (MEK116513)

Phase 3

Recruiting

• Conditions: melanoma of the skin; 10040900

• Registration Number: NL-OMON46883
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

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 29).
• Cardiovascular risk (see protocol page 30 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>Overall survival.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Progression free survival, overall response rate, duration of response, safety,<br /><br>tolerability.</p><br>