Experimental vaccine aims to stop rare eye cancer from returning

NCT ID NCT01983748

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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 This study
The trial has finished. Results may not be published yet.
Stopped early
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.

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested a personalized vaccine made from a patient's own immune cells and tumor RNA in 200 people with a high-risk form of eye cancer (uveal melanoma with monosomy 3). After surgery to remove the tumor, half received the vaccine over two years and half were simply observed. The goal was to see if the vaccine could prevent the cancer from coming back and improve survival.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2014

Finished

Dec 2024

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 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Patients must suffer from melanoma of the uvea (stage T2, T3 and T4 \[AJCC TNM grading 2009\]). * Uveal melanoma must be resected and display a monosomy for chromosome 3 (will be determined by a validated qualitative analysis of loss of heterozygosity). Tumor material has to be stored appropriately in RNAlater solution for RNA preparation. * The patient has to be free of detectable tumor at the time point of study enrollment (adjuvant setting), as assessed by clinical inspection, abdominal sonography, chest X-ray and evaluation of the tumor-marker S-100.. * Patients must have a WHO performance status of 0, 1 or 2 and must be in stable medical condition. * Patients must be between 18 and 75 years old and must be able and willing to give informed consent. * Women of child-bearing age must have a negative pregnancy test, and must oblige to use effective contraception until at least 4 weeks after the last vaccination. * Patients must be willing to get hospitalized for at least 4 hours following vaccination(s), and to cooperate for the whole period of the trial. * Patients must have fully recovered from surgery. * Signed informed consent Exclusion Criteria: * Any other major serious illness \[e.g. active systemic infections, immunodeficiency disease, clinically significant heart disease, respiratory disease, bleeding disorders, cancer etc.\] or a contraindication to leukapheresis. * Evidence for HIV-1, HIV -2, HTLV-1, HBV, or HCV infection. * Active autoimmune disease (such as but not limited to Lupus erythematosus, autoimmune thyroiditis or uveitis, multiple sclerosis, inflammatory bowel disease). Vitiligo and pathological laboratory results (autoantibodies) without clinical symptoms are, however, not an exclusion criterion. * Previous splenectomy or radiation therapy to the spleen. * Patients with organ allografts. * Concomitant treatment with chemotherapy, immunotherapy, any investigational drug and paramedical substances. Patients may receive concomitant medications to control symptoms such as analgetics, antihypertensive medication, etc. * History of other active malignant neoplasm within the preceding 5 years (excluding non-melanoma skin cancer or carcinoma in situ of the cervix). * Organic brain syndrome or significant psychiatric abnormality which would impede informed consent and / or AND preclude participation in the full protocol and follow up. * Positive pregnancy test / Pregnancy or lactation. If pregnancy occurs during the course of the trial to female patients in arm A or B, the patient has to be excluded. * Detection of metastases. If uveal melanoma metastases appear during the course of the trial, the patient has to be excluded. * Lack of compliance of the patient.

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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

  • Dept. of Dermatology, University Hospital

    Erlangen, Bavaria, 90154, Germany

  • Städtisches Klinikum

    Dessau, 06847, Germany

  • University Hospital Department of Ophtalmology

    Erlangen, Bavaria, 91054, Germany

  • University Hospital Department of Ophtalmology

    Würzburg, Bavaria, 97080, Germany

  • University Hospital Department of Ophtalmology

    Essen, 45122, Germany

  • University Hospital Department of Ophtalmology

    Homburg/Saar, 66421, Germany

  • University Hospital Department of Ophtalmology

    Lübeck, 23538, Germany

  • University Hospital Department of Ophtalmology

    Tübingen, 72076, Germany

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