A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With NRAS-mutant Melanoma (SEACRAFT-2)

Korábbi kezelés

• Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor
• Patients receiving treatment with herbal medicine known to cause liver toxicity, which cannot be discontinued 7 days prior to first dose of study drug(s) and for the duration of the study.

Más betegség

• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug(s) (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection)
• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome)

Laborértékek

• LVEF <50%

Egyéb

• Patients with uveal or mucosal melanoma
• Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible.
• Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

• Willing and able to provide written informed consent
• Age ≥ 18 years
• Histologically or cytologically confirmed unresectable or metastatic cutaneous (includes acral) melanoma.
• Documentation of an NRAS mutation (tumor tissue or blood) prior to first dose of study drug(s) as determined locally with an analytically validated assay in a certified testing laboratory.
• Archival tumor tissue collected within 5 years prior to enrollment must be confirmed to be available at the time of Screening, which may be submitted before or after enrollment for exploratory biomarker analysis.
• Must have received an anti-PD-1/L1 based regimen (monotherapy or combination). Patient must have documented disease progression either while receiving therapy or within 12 weeks of last dose of the most recent anti-PD-1/L1 based regimen; the patient is eligible if they have received other therapies between the most recent anti-PD-1/L1 based regimen and enrollment.
• ECOG performance status 0, 1 or 2
• Presence of at least 1 measurable lesion according to RECIST v1.1
• Able to swallow oral medication.