Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal M… (NCT03472586) | Clinical Trial Compass
CompletedPhase 2
Ipilimumab and Nivolumab With Immunoembolization in Treating Participants With Metastatic Uveal Melanoma in the Liver
United States14 participantsStarted 2018-05-02
Plain-language summary
This phase II trial studies ipilimumab and nivolumab with immunoembolization in treating patients with uveal melanoma that has spread to the liver. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Immunoembolization may kill tumor cells due to loss of blood supply and develop an immune response against tumor cells. Giving ipilimumab and nivolumab with immunoembolization may work better in treating patients with uveal melanoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed metastatic uveal melanoma in the liver; patients must have at least one measurable liver metastasis that is \>= 10 mm in longest diameter by computed tomography (CT) scan or magnetic resonance imaging (MRI)
* The total volume of the tumors must be less than 50% of the liver volume
* Willingness and ability to give informed consent
* Agreement to access archival tissue or agreement for tumor biopsy prior to treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
* Serum creatinine =\< 2.0 mg/dl
* Granulocyte count \>= 1000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Bilirubin =\< 2.0 mg/ml
* Albumin \>= 3.0 g/dl
* Prothrombin time (PT)/partial thromboplastin time (PTT) less than 1.5 times normal
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 3 x upper limit of normal (ULN)
* Alkaline phosphatase less than 1.5 times ULN (grade 1)
* Women must not be pregnant or breast-feeding
* Women of child-bearing potential must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 23 weeks after the last dose of nivolumab and/or ipilimumab and sexually active males must use at least two other accepted and effective methods of contraception and/or to abstain from sexual intercourse for at least 31 weeks after the last dose of nivolumab and/or ipilimumab
Exclusion Criteria:
* Failure to meet any of the criteria se…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hepatic Metastasis Stabilization Rate by Response Criteria (Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)
Timeframe: At the end of 4th treatment cycle (Day 84 +/- 3 days). Cycles are 21 days.
Trial details
NCT IDNCT03472586
SponsorSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University