Experimental vaccine aims to stop rare eye cancer from returning
NCT ID NCT01983748
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2014
- Finished
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Dec 2024
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 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: * 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
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Dept. of Dermatology, University Hospital
Erlangen, Bavaria, 90154, Germany
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Städtisches Klinikum
Dessau, 06847, Germany
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University Hospital Department of Ophtalmology
Erlangen, Bavaria, 91054, Germany
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University Hospital Department of Ophtalmology
Würzburg, Bavaria, 97080, Germany
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University Hospital Department of Ophtalmology
Essen, 45122, Germany
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University Hospital Department of Ophtalmology
Homburg/Saar, 66421, Germany
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University Hospital Department of Ophtalmology
Lübeck, 23538, Germany
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University Hospital Department of Ophtalmology
Tübingen, 72076, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Hepatic arterial infusion of autologous tumor infiltrating lymphocytes preconditioned with percutaneous hepatic perfusion with melphalan in patients with melanoma and liver metastases
- 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?
- Supercharged immune cells take aim at childhood cancers