Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma (NCT05170334) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma
United States7 participantsStarted 2021-12-15
Plain-language summary
This research study is investigating Binimetinib and Belinostat in participants with metastatic uveal melanoma. The research study will test the study drugs to see if the combination of binimetinib and belinostat can make tumors shrink or stop growing.
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:
* Provision of signed and dated informed consent form.
* Male or female, aged \>/= 18 years old
* Life expectancy of greater than 3 months in the opinion of the investigator
* Must have metastatic uveal melanoma, either initial presentation or recurrent, that is histologically diagnosed
* Participant must have ECOG performance status of 0-1
* Participant must have measurable disease, according to RECIST version 1.1
* Participants must have normal organ and marrow function as defined below:
* Leukocytes \>3,000/mcL
* Absolute neutrophil count \>1,500/mcL
* Platelets \>100,000/mcL
* Total bilirubin within 1.5 x institutional upper limit of normal
* AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
* Creatinine within 1.5 x institutional upper limit of normal OR creatinine clearance \>60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
* An echocardiogram should be performed at baseline in all patients. Ejection fraction (EF) from baseline echocardiogram must be within the institutional limits of normal as determined by the reading cardiologist. The left ventricular ejection fraction (LVEF) must be ≥50%
* Participants on full-dose anticoagulants (e.g., warfarin) with PT INR \>1.5 are eligible provided that both of the following criteria are met:
* a) The participant has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
* b) The pa…
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.
1This trial is testing a combination of two drugs — binimetinib and belinostat — for metastatic uveal melanoma specifically. Can you explain how these two drugs work together, and why this combination might make sense for my type of melanoma compared to treatments developed for more common skin melanoma?
2Since this is a Phase 2 trial, what do we know so far about the safety profile of this drug combination, and what side effects should I be most prepared for if I were to consider joining?
3The trial is no longer enrolling new patients, so am I still able to participate, and if not, is there any way to access binimetinib or belinostat outside of this trial — such as through compassionate use or another study?
4The trial's main goal is measuring Overall Response Rate, meaning how many patients' tumors shrink. Does that tell us anything yet about how durable any responses might be, or whether this approach could affect survival outcomes for metastatic uveal melanoma?
5Given that metastatic uveal melanoma has limited standard treatment options, would you recommend I try any existing approved therapies first before exploring an experimental combination like this one, or does my specific situation make a trial like this worth prioritizing?
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
Overall Response Rate
Timeframe: Up to 5 years
Trial details
NCT IDNCT05170334
SponsorH. Lee Moffitt Cancer Center and Research Institute