A multicenter prospective observational study of a sequential regimen of immune-checkpoint inhibitors and BRAF/MEK inhibitors for advanced BRAF V600-mutant melanoma (B-CHECK-SW study)

UMIN ID: UMIN000056632

Registered date:05/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: malignant melanoma
• Date of first enrollment: 2025/01/06
• Target sample size: 140
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 2-year overall survival
• Secondary Outcome: Treatment sequencing patterns in daily practice Progression-free survival (PFS) Objective response rate (ORR) Treatment-related adverse events (TRAEs)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) Prior history of systemic therapy with BRAF/MEK inhibitors or immune-checkpoint inhibitors (excluding adjuvant/neoadjuvant therapy). 2) History of Grade 3 or higher adverse events induced by adjuvant/neoadjuvant therapy with BRAF/MEK inhibitors or immune checkpoint inhibitors (excluding patients who could continue treatment with hormone replacement therapy). 3) Presence of other active malignancy. 4) Presence of active autoimmune disease. 5) Receiving systemic corticosteroids exceeding 10 mg/day prednisolone equivalent or immunosuppressive medications. 6) History or presence of uncontrolled or severe cardiac disease. 7) History of interstitial lung disease. 8) Pregnant or lactating women. 9) Any other condition deemed unsuitable for enrollment by the treating physician.

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED),National Cancer Center Research and Development Fund