melanoma
Conditions
Interventions
Treatment with dabrafenib plus trametinib or placebo.
Sponsors
Novartis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Subjects with histologically confirmed completely resected, BRAF V600E/K high risk, stage III cutaneous melanoma • Surgically rendered free of disease no more than 12 weeks before randomization. • 18 years and above. • ECOG Performance Status 0-1. • Females of childbearing potential: adequate method of contraception.
Exclusion criteria
Exclusion criteria: • Known mucosal or ocular melanoma or the presence of unresectable in-transit metastases. • Evidence of distant metastatic disease. • Prior anti-cancer treatment incl. radiotherapy for melanoma.Prior surgery for melanoma is allowed. • History of another malignancy including melanoma or a concurrent malignancy. See protocol page 33 for details and exceptions. • A history or evidence of cardiovascular risk (see protocol page 33 for details). • A history or current evidence/risk of retinal vein occlusion or central serous retinopathy (see protocol page 34 for details). • History of interstitial lung disease or pneumonitis. • Pregnancy or breastfeeding
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, distant metastasis-free survival, freedom from relapse, safety, tolerability. | — |
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival. | — |
Countries
Netherlands
Outcome results
None listed