Promising combo for eye cancer stalls after only 3 patients enrolled
NCT ID NCT03712904
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This phase II trial tested a combination of precise radiation therapy followed by injections of aflibercept (Eylea) in people with uveal melanoma, a rare eye cancer. The goal was to see if this approach could control the tumor while reducing side effects like swelling or damage to the retina. However, the study was terminated early after enrolling only 3 participants, so we have very little data to draw conclusions from.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- aflibercept (Eylea) and stereotactic body radiation therapy
- What this could lead to
- If successful, this combination could offer a new way to control uveal melanoma while reducing damage to healthy eye tissue.
- What could go wrong
- This was a very small, early-phase trial that was terminated early with only 3 participants, so results are extremely limited and may not apply to others.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
3 people
The number who actually took part.
- Started
-
Aug 2019
- Finished
-
Dec 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 or serum 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Uveal melanoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can flooding the liver with chemotherapy stop ocular melanoma?
- Liver-Targeted immune cell attack tested against melanoma spread
- Can a pill combo keep uveal melanoma from coming back?
- Can tracking a rare eye cancer pave the way for new treatments?
- Can a new drug tame advanced solid tumors?
- Can a single eye injection shrink melanoma and save sight?