Study on Tebentafusp-tebn with Liver-Directed Therapies for Metastatic Uveal Melanoma

Inclusion Criteria

• Must be 18 years or older.
• Have confirmed metastatic uveal melanoma in the liver with at least one liver tumor 10 mm or larger.
• For Part 1: Liver tumors must be less than 50% of the liver's volume, with the largest tumor 5 cm or smaller.
• For Part 2: Have larger liver tumors or more than 50% liver involvement.
• No previous treatment with tebentafusp-tebn.
• For Part 1: No prior treatment for metastatic cancer, but previous surgery or radiation for limited disease is allowed.
• For Part 2: May have had previous treatments, but no more than two different types.
• Must be HLA-A*0201 positive.
• Good overall health with a performance status of 0 or 1.
• Life expectancy of more than 3 months.
• Normal organ and bone marrow function, including specific blood counts and liver/kidney function.
• Women must not be pregnant or breastfeeding and must use effective birth control during and after the study.
• Men must use effective birth control during and after the study.
• Must understand and agree to the study requirements.

Exclusion Criteria

• Do not meet the inclusion criteria.
• Previous use of tebentafusp-tebn.
• Prior chemoembolization for Part 2.
• Severe allergic reactions to certain drugs or contrast agents.
• Symptomatic liver failure or untreated brain metastases.
• Recent major surgery or radiation therapy.
• Unresolved side effects from previous treatments.
• Recent use of investigational drugs or certain growth factors.
• Active infections like HIV, hepatitis B, or C.
• Use of systemic steroids or immunosuppressive drugs.
• History of bleeding disorders.
• Pregnant or breastfeeding women.
• Other serious health conditions or liver issues that could interfere with the study.
• For Part 1: Severe allergic reactions to GM-CSF.