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)

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) - MEK115306

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47344

Enrollment

Registered

2012-04-13

Start date

2012-07-16

Completion date

Unknown

Last updated

2024-05-06

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 dabrafenib plus a placebo.

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 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

Design outcomes

Primary

Measure	Time frame
Progression free survival.	—

Secondary

Measure	Time frame
Overall survival, overall response rate, duration of response, safety, tolerability, PK.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)