Stereotactic Body Radiation Therapy and Aflibercept in Treating Patients With Uveal Melanoma

PRIMARY OBJECTIVES:

I. To assess the percentage of patients able to successfully complete their prescribed
treatment of radiation and intravitreal ziv-aflibercept (aflibercept) injection (IAI) with an
acceptable level of toxicity.

SECONDARY OBJECTIVES:

I. To assess for reduction in the incidence of 2-year rates of radiation maculopathy,
radiation papillopathy, functional vision preservation, radiation glaucoma, and to assess
2-year local control and progression-free survival.

Inclusion Criteria:

- Provide signed and dated informed consent form or have a Legally Authorized
Representative (LAR) who can give consent

- Willing to comply with all study procedures and be available for the duration of the
study

- Must be a candidate for radiation therapy

- Karnofsky performance status (KPS) >= 60

- Diagnosed with uveal melanoma either clinically or pathologically on biopsy

- Uveal melanoma of one eye only

- Localized uveal melanoma, with no evidence of metastasis

- Women of childbearing potential must have a negative urine pregnancy test within 14
days prior to enrollment

Exclusion Criteria:

- Tumor thickness more than 14 mm as measured by ultrasound

- Active collagen vascular disease

- Any contraindication to intravitreal injections including: elevated intraocular
pressure, ocular or periocular infection, active intraocular inflammation, or other
determined by treating physician

- Known allergic reactions to components of intravitreal Aflibercept

- Patients with known hypercoagulable syndromes

- Prior radiation to the eye or brain

- Life expectancy less than 6 months

- Blind in both eyes

- Patients unable to receive contrast enhanced brain magnetic resonance imaging (MRI)

- Deaf in both ears

- Patients have hypersensitivity to intravitreal Aflibercept

- Patients is on or within 1 month of systemic anti-VEGF treatment

- Patients who are candidates for brachytherapy

- Patients for whom enucleation is standard of care

- Pregnancy or active breastfeeding. Sexually active men or women of childbearing
potential who are unwilling to practice adequate contraception prior to the initial
dose/start of the first treatment, during the study, and for at least 3 months after
the last dose. Adequate contraceptive measures include stable use of oral
contraceptives or other prescription pharmaceutical contraceptives for 2 or more
menstrual cycles prior to screening; intrauterine device; bilateral tubal ligation;
vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus
contraceptive sponge, foam, or jelly

- Contraception is not required for men with documented vasectomy

- Postmenopausal women must be amenorrheic for at least 12 months in order not to
be considered of childbearing potential. Pregnancy testing and contraception are
not required for women with documented hysterectomy or tubal ligation