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

NCT03712904 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 18P.457JT 11801
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveal Melanoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  Percent of patients who experience Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade ≥3 toxicity related to SRT and/or intravitreal Aflibercept.

  Up to approximately 6 months

Secondary Outcomes (2)

• Radiation Maculopathy Rate Defined as Ophthalmoscopic Detection of Macular Edema Perivascular Sheathing

  At 2 years

• Radiation Papillopathy Rate Defined as Ophthalmoscopic Detection of Peripapillary Encircling Nerve Fiber Layer Infarction

  At 2 years

Study Arms (2)

A. Stereotactic body radiation therapy, ziv-aflibercept

EXPERIMENTAL

Patients undergo stereotactic body radiation therapy over 5 fractions every other week day during days 1-10. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 2 months for up to 2 years in the absence of disease progression or unacceptable toxicity.

Radiation: Stereotactic Body Radiation Therapy

B. Stereotactic body radiation therapy, ziv-aflibercept

EXPERIMENTAL

Patients undergo stereotactic body radiation therapy as in arm A. Patients then receive ziv-aflibercept IVI on the last day of radiation therapy and then every 4 months for up to 2 years in the absence of disease progression or unacceptable toxicity.

Biological: Ziv-Aflibercept

Interventions

Stereotactic Body Radiation Therapy RADIATION

Undergo radiation

Also known as: SBRT, Stereotactic Ablative Body Radiation Therapy

A. Stereotactic body radiation therapy, ziv-aflibercept

Ziv-Aflibercept BIOLOGICAL

Given IV

Also known as: 724770, 862111-32-8, AVE0005, Eylea, Vascular Endothelial Growth Factor Trap

B. Stereotactic body radiation therapy, ziv-aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 or serum pregnancy test within 14 days prior to enrollment

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Uveal Melanoma

Interventions

Radiosurgery; aflibercept

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Wenyin Shi, MD, PhD
• Organization: Thomas Jefferson University

wenyin.shi@jefferson.edu

(215) 955-6702

Study Officials

• Wenyin Shi, MD, PhD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 19, 2018
• Study Start: August 9, 2019
• Primary Completion: September 20, 2022
• Study Completion: December 23, 2022
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Locations

US (1)