Study on Treating Melanoma with ALK Alterations Using Ensartinib

Inclusion Criteria

• Must be 18 years or older.
• Have advanced melanoma confirmed by lab tests.
• For the treatment phase, must have melanoma that has worsened after treatment with PD-1 inhibitors, with or without ipilimumab. If the melanoma has a BRAF V600 change, prior treatment with BRAF inhibitors is required. Uveal melanoma patients are exempt from PD-1 progression requirements.
• Tumors must have an ALK alteration confirmed by a certified lab.
• Disease must be measurable by standard criteria, unless it has been treated locally in the past 30 days.
• Untreated brain metastases are allowed if they are not causing symptoms. Treated brain metastases are allowed if they have not required increased steroid doses in the past 2 weeks.
• Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
• Must have acceptable liver, kidney, and blood function as determined by specific tests.

Exclusion Criteria

• Cannot have had any prior treatment with ALK inhibitors.
• Cannot have had immune-activating treatments within a short period before starting the study.
• Cannot have had BRAF/MEK treatments within 3 weeks before starting the study.
• Cannot have had other cancer treatments within 3 weeks or one cycle length before starting the study.
• Cannot have had major surgery or radiation therapy within 2 weeks before starting the study.
• Cannot have another active cancer that would interfere with the study.
• Cannot be taking certain medications that affect liver enzymes.
• Cannot have significant heart problems, such as abnormal heart rhythms or uncontrolled high blood pressure.
• Cannot have had serious heart conditions or strokes within 6 months before starting the study.
• Cannot have serious infections at the time of treatment.
• Cannot have lung diseases that could interfere with the study.
• Cannot be pregnant or breastfeeding, and must agree to use contraception during and for 3 months after the study.