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Promising combo for eye cancer stalls after only 3 patients enrolled

NCT ID NCT03712904

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.