Immunotherapy combo eyed as Pre-Surgery option for rare eye cancer
NCT ID NCT07501117
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This early-phase trial tests whether giving two immunotherapy drugs (nivolumab and ipilimumab) before eye removal surgery is safe and feasible for people with high-risk uveal melanoma, a rare eye cancer. Fifteen participants will receive the drugs, then have their eye removed. The study will track side effects and how many complete the treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab and ipilimumab (immunotherapy drugs)
- What this could lead to
- If this works, it could show that giving immunotherapy before surgery is safe and may help control the spread of uveal melanoma.
- What could go wrong
- This is a very early, small trial with only 15 people. It focuses on safety and feasibility, not effectiveness. The drugs can cause serious immune-related side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- 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 80 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: * Age ≥ 18 ≤ 80 * The patient is able to read and understand Danish. * Primary, localized and treatment-naive uveal melanoma planned for enucleation (high risk/T3-T4) and available for transvitreal biopsies. The initial diagnosis of uveal melanoma is based on ophthalmologic and clinical findings. * ECOG performance status of 0 or 1 (appendix 2) * The patient meets the following haematological and biochemical criteria at time of screening: a) AST and ALT ≤2,5 X ULN, b) Serum total bilirubin ≤1,5 X ULN or direct bilirubin ≤ ULN for patient with total bilirubin level \> 1,5 ULN, c) Serum creatinine ≤1,5 X ULN, d) ANC (Absolute Neutrophil Count) ≥1,000/mcL, e) Platelets ≥ 75,000 /mcL, f) Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L * Signed statement of consent after receiving oral and written study information * Willingness to participate in the planned treatment and follow-up schedule * For women of childbearing potential (WOCBP) a negative serum pregnancy test at time of screening and the use of highly effective contraception is required. This applies from screening and until 6 months after treatment. The following is considered highly effective methods of contraception: 1. Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal or transdermal), 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) 3. Intrauterine device (IUD) 4. intrauterine hormone-releasing system (IUS) 5. Bilateral tubal occlusion, 6. Vasectomised partner provided that the vasectomy is confirmed successful, 7. Sexual abstinence defined as refraining from heterosexual intercourse. WOCBP must also agree to refrain from egg donation, storage, or banking during these same time periods. \- Men with female partner of childbearing potential must: 1. Use a condom during sexual intercourse from screening and until 6 months after treatment. 2. Ensure that their partner uses a highly effective method of contraception (as described above) 3. Agree to refrain from sperm donation, storage, or banking Exclusion criteria * A history of prior malignancies. Patients treated for another malignancy can participate if they are without signs of disease for a minimum of 2 years after treatment. Subjects with curatively treated ductal carcinoma in situ (DCIS or LCIS) breast cancer for which they are taking hormonal therapy is acceptable. Resectable squamous or basal cell carcinoma of the skin is acceptable. * Requirement for immunosuppressive doses of systemic corticosteroids (\>10 mg/day prednisone or equivalent) or other immunosuppressive drugs within the last 3 weeks prior to screening * The patient has any condition that will interfere with patient compliance or safety (including but not limited to psychiatric or substance abuse disorders) * The patient is pregnant or breastfeeding * The patient has an active infection requiring systemic therapy * Significant medical disorder according to investigator; e.g severe asthma or chronic obstructive lung disease, dysregulated heart disease or dysregulated diabetes mellitus. * Concurrent treatment with other experimental drugs * Any significant active autoimmune disease * Severe allergy or anaphylactic reactions earlier in life * Known hypersensitivity to one of the active drugs or one or more of the excipients.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Center for Cancer Immune Therapy, Department of Oncology, Herlev Hospital
RECRUITINGHerlev, Herlev, 2730, Denmark
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?