Patients
hepatitis B, squamous cell or basal cell carcinoma, tumor, ascites, uveal melanoma, neuropathy, malignancy, immune-mediated colitis, Tumors, human immunodeficiency virus, alopecia, colitis
HEPATITIS B, ASCITES, TUMOR, HUMAN IMMUNODEFICIENCY VIRUS, UVEAL MELANOMA, NEUROPATHY, CENTRAL NERVOUS SYSTEM METASTASES, TUMORS, CERVICAL CANCER, IMMUNE-MEDIATED COLITIS, ONCOLOGY, ALOPECIA, METASTASES, AUTOIMMUNE DISEASE, COLITIS
Eligible patients were ≥ 18 years of age and had a histologically or cytologically confirmed diagnosis of uveal melanoma per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and metastases to the liver, with an estimated tumor volume in the liver less than one-third of the total liver volume (based on computed tomography [CT] or magnetic resonance imaging [MRI]) and no single metastatic lesion more than 8 cm in the longest diameter. Additional eligibility criteria included an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, adequate organ function, and life expectancy > 12 weeks. Patients who received prior treatment were required to have progression per RECIST version 1.1 during or after the last treatment. Prior treatment with an immune checkpoint inhibitor was permitted, following a 6-week washout period. Patients were excluded if they were candidates for surgery or locoregional treatment with curative intent; had active central nervous system metastases or any other known malignancy (other than squamous cell or basal cell carcinoma treated with potentially curative therapy or in situ cervical cancer) that was progressing or required active treatment; were receiving systemic steroid therapy at > 10 mg prednisone or equivalent; had active autoimmune disease, active colitis or previous immune-mediated colitis that has not resolved to grade ≤ 1, hepatitis B or C, or grade > 2 ascites; had a history of human immunodeficiency virus; had received chemotherapy, targeted small-molecule therapy, radiation therapy, hormonal treatment, or immunotherapy within 21 days before the first dose of study drug or had any residual grade > 1 toxic effects (or grade > 2 alopecia or neuropathy) from the most recent therapy; or had any other concurrent, uncontrolled illness, condition, therapy, or laboratory abnormality that might interfere with the patient’s participation or confound study results.All patients provided written informed consent to participate. The study was conducted in accordance with the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice guidelines, and all applicable local and national laws. The institutional review board at each study site approved the protocol, all protocol amendments, and informed consent forms before the study began.