Expanded Access Program for Tebentafusp for Patients with Metastatic or Unresectable Uveal Melanoma

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of metastatic or unresectable uveal melanoma.
• Have a specific genetic marker called HLA-A*02:01.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Be able to understand and provide informed consent.
• If of childbearing potential, must agree to use effective birth control during the program and for one week after the last dose.
• Pregnant or breastfeeding women cannot participate.
• Men must not donate sperm during the program and for three months after the last dose.

Exclusion Criteria

• Have untreated or symptomatic brain metastases or spinal cord compression. Treated brain lesions must be stable for at least two weeks and not require steroids.
• Have received certain cancer treatments within specific timeframes before starting the program:
  • T-cell therapies: 90 days
  • CTLA-4 immunotherapies: 28 days
  • Other immunotherapies: 21 days
  • Other systemic therapies: 14 days
  • Radiotherapy: 14 days (except for limited palliative radiotherapy)
• Be on systemic steroids or immunosuppressive drugs within two weeks of starting the program, with some exceptions for low-dose or specific uses.
• Have any medical condition that the doctor believes would make participation unsafe or affect the program's results.
• Have chronic viral infections like HIV, hepatitis B, or hepatitis C, unless under control with treatment.
• Have certain abnormal lab results, such as low kidney function or high liver enzymes.
• Have significant heart disease or uncontrolled high blood pressure.
• Have had a recent heart attack or unstable chest pain.