Open Label Phase II Study of AntiCTLA4 in Patients With Unresectable or Metastatic Uveal Melanoma
- Histologically confirmed uveal melanoma including choroidal melanoma, iris melanoma,
and ciliary body melanoma
- Patients may either have measurable disease or non-measurable disease.
- Biopsies from a readily accessible site of disease on study enrollment are mandatory
in principle. Waivers will be granted if there are no accessible lesions. The
collection of a representative block of the diagnostic tumour tissue (if available)
- ECOG performance status of 0 or 1
- Age 18 years or older
- Adequate bone marrow, hepatic, and renal function determined within 14 days prior to
registration, defined as:
- Serum lactic acid dehydrogenase (LDH) = 1.5 x ULN.
- Alkaline phosphatase (ALP) = 2 x ULN.
- No weight loss >/= 10% in the proceeding 4 weeks.
- CT scan of the brain with contrast or MRI of the brain within 28 days of registration
showing no evidence of brain metastases.
- Females of childbearing potential must have a negative serum or urine pregnancy test
within 14 days prior to registration. Females who have undergone surgical
sterilization or who have been postmenopausal for at least 2 years are not considered
to be of childbearing potential.
- Females of childbearing potential and males who have not undergone surgical
sterilization must agree to practice a form of effective contraception prior to entry
into the study and for 12 months following the last dose of study drug. The
definition of effective contraception will be based on the judgment of the
- Melanoma of cutaneous, mucosal or conjunctival origin.
- History of brain or leptomeningeal metastases.
- Received any prior CTLA4 inhibiting agent (eg MDX-010, ipilimumab) or other
- History of chronic inflammatory or autoimmune disease
- History of uveitis or melanoma-associated retinopathy.
- History of inflammatory bowel disease, celiac disease, or other chronic
gastrointestinal conditions associated with diarrhea or bleeding, or current acute
colitis of any origin.
- History of hepatitis due to Hepatitis B virus or Hepatitis C virus