malignant melanoma
Conditions
Interventions
None listed
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histopathologically confirmed melanoma. 2) BRAF V600 mutation confirmed by in vitro diagnostic test approved in Japan. 3) Presence of distant metastases or surgically unresectable disease. 4) For cutaneous primary melanoma, diagnosed as stage III or IV according to AJCC 8th edition. 5) Measurable lesions on whole-body CT scan at baseline. 6) Aged 18 years or older at enrollment. 7) ECOG Performance Status of 0-2. 8) Able to swallow oral medications and the absence of clinically significant gastrointestinal disorders that may affect drug absorption. 9) Adequate bone marrow and organ function. 10) Written informed consent.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment sequencing patterns in daily practice Progression-free survival (PFS) Objective response rate (ORR) Treatment-related adverse events (TRAEs) | — |
Countries
Japan
Contacts
Public ContactKenjiro Namikawa
National Cancer Center Hospital Department of Dermatologic Oncology
Outcome results
None listed