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)

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) - MEK116513

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46883

Enrollment

Registered

2012-05-29

Start date

2012-09-07

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

melanoma of the skin

Interventions

Treatment with dabrafenib plus trametinib or vemurafenib.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Overall survival.	—

Secondary

Measure	Time frame
Progression free survival, overall response rate, duration of response, safety, tolerability.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)