Study on the Effectiveness and Safety of LXH254 Combinations in Patients with Previously Treated Advanced Melanoma

Inclusion Criteria

• Must be 12 years or older.
• For ages 12-17, must weigh more than 40 kg (about 88 pounds).
• Must have a confirmed diagnosis of advanced melanoma that cannot be removed by surgery or has spread.
• Must have previously received treatment for advanced melanoma:
  • If you have an NRAS mutation:
    • Must have had prior treatment with checkpoint inhibitors (CPI), such as anti-PD-1/PD-L1, alone or with other agents like anti-CTLA-4, chemotherapy, or investigational drugs.
    • Can have had up to two previous treatments with CPI for advanced melanoma.
    • Must show confirmed disease progression after CPI treatment, unless you were on treatment for more than 6 months.
  • If you have a BRAFV600 mutation:
    • Must have had prior treatment with CPI and targeted therapy with a RAF inhibitor, alone or with a MEK inhibitor.
    • Can have had up to two previous treatments with CPI and one line of targeted therapy, which must be the most recent.
    • Must show disease progression after targeted therapy.
• Other criteria may apply as defined by the study protocol.

Exclusion Criteria

• Recent treatment with certain cancer therapies before starting the study:
  • Radiation therapy within 4 weeks, or limited radiation for symptom relief within 2 weeks.
  • Small molecule drugs within 2 weeks.
  • Immunotherapy, including checkpoint inhibitors, within 4 weeks.
  • Chemotherapy or other investigational drugs within 4 weeks.
  • Cytotoxic drugs with delayed side effects, like nitrosourea or mitomycin c, within 6 weeks.
• Participation in other drug or medical device studies at the same time.
• Having primary brain tumors or unstable brain metastases.
• History or current risk of retinal vein occlusion (RVO), such as uncontrolled eye pressure or blood disorders.
• Any medical condition that could make participating in the study unsafe or difficult.
• Other criteria may apply as defined by the study protocol.