NCT03712904

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

Phase II Randomized Trial of Stereotactic Radiotherapy (SRT) Followed by Intravitreal Aflibercept Injection for Patients With Ocular Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This phase II trial studies how well stereotactic body radiation therapy and aflibercept work in treating patients with uveal melanoma. Stereotactic body radiation therapy is a specialized radiation therapy that sends x-rays directly to the tumor using smaller doses over several days and may cause less damage to normal tissue. Aflibercept may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving stereotactic body radiation therapy followed by aflibercept may work better in treating patients with uveal melanoma.

Detailed description

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.

Conditions

• Uveal Melanoma

Interventions

Type	Name	Description
RADIATION	Stereotactic Body Radiation Therapy	Undergo radiation
BIOLOGICAL	Ziv-Aflibercept	Given IV

Timeline

• Start date: 2019-08-09
• Primary completion: 2022-09-20
• Completion: 2022-12-23
• First posted: 2018-10-19
• Last updated: 2025-09-24
• Results posted: 2025-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study