New combo attack on eye cancer that spreads to the liver

NCT ID NCT04283890

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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.

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This status has not been confirmed recently, so it may be out of date.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 study tests a combination of two immunotherapy drugs (ipilimumab and nivolumab) plus a chemotherapy drug (melphalan) given directly to the liver through a special procedure. It includes 83 adults with advanced uveal melanoma that has spread mainly to the liver. The goal is to see if this approach is safe and can slow or stop the cancer from growing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ipilimumab, nivolumab, and melphalan
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced uveal melanoma that has spread to the liver, potentially improving control of the disease.
What could go wrong
This is an early-phase trial with only 83 participants, so results may not apply to everyone. The combination of immunotherapy and chemotherapy can cause serious side effects, and it is not yet known if it will 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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 83 people

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

Started

Dec 2019

Expected to finish

Dec 2029

An estimate. End dates often move.

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: 1. Age between 18-75 yrs 2. World Health Organization (WHO) Performance Status 0 or I 3. 50% or less histologically or cytologically confirmed unresectable metastatic uveal melanoma in the parenchyma of the liver 4. Hepatic metastases, confined to or predominantly in the liver 5. No prior systemic treatment (including chemotherapy, vaccine therapy, monoclonal Ab treatment, IL-2) 6. Local pre-treatment of uveal melanoma metastases is allowed (resection and/or thermal ablation), except for chemotherapy containing procedures (e.g. chemoembolization) and radio-embolization, and as long as patients have progressed with measurable disease according to RECIST 1.1 7. No concurrent systemic immunosuppressive medications ≥ 10mg/day prednisone or equivalent. Topical, inhaled, nasal and ophthalmic steroids, and adrenal replacement therapy are allowed. 8. Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥ 1.0x109/L, Platelets ≥ 100 x109/L, Hemoglobin ≥ 6.5 mmol/L, Creatinine ≤ 2x ULN, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH \< 2xULN 9. Women of child bearing potential (WOCBP) must agree to use a reliable form of contraceptive as described in paragraph 5.4. 10. Men must agree to the use of male contraception as described in paragraph 5.4. 11. Absence of additional severe and/or uncontrolled concurrent disease 12. No prior, or ongoing other malignancy, except adequately treated basal cell or squamous cell skin cancer, cervical cancer in situ or adequately treated other cancer with eradicative intent for which the patient has been continuously disease-free for \> 2 years. 13. No aberrant vascular anatomy of the liver that precludes PHP Exclusion Criteria: 1. Cerebral or meningeal metastasized uveal melanoma 2. Subjects with any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressive medications, except for subjects with vitiligo or resolved childhood asthma/atopy; 3. Prior immunotherapy (tumor vaccine, cytokine, or growth factor) 4. Known history of infection with Human Immunodeficiency Virus; 5. Active infection requiring therapy, positive serology for Hepatitis B surface antigen or Hepatitis C ribonucleic acid (RNA) 6. History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes (unstable or severe angina, recent myocardial infarction), significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia. 7. History or evidence of clinically significant pulmonary disease e.g. severe COPD that precludes the use of general anesthesia. 8. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events; 9. Latex allergy, and known hypersensitivity/allergy to ipilimumab, nivolumab, melphalan or heparin 10. Prior Whipple's Surgery 11. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids; 12. History of or current immunodeficiency disease, splenectomy or splenic irradiation; prior allogeneic stem cell transplantation; 13. Patients who are unable to be temporarily removed from chronic anti-coagulation therapy. 14. Patients with active bacterial infections with systemic manifestations (malaise, fever, leucocytosis) are not eligible until completion of appropriate therapy. 15. Use of other investigational drugs before study drug administration for systemic malignancy 16. Pregnancy or nursing

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis uveal melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA, Netherlands

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