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 range18 Years
SexALL
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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…
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