Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma

  • STATUS
    Recruiting
  • End date
    Dec 10, 2026
  • participants needed
    32
  • sponsor
    H. Lee Moffitt Cancer Center and Research Institute
Updated on 10 July 2022

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.

Details
Condition Metastatic Uveal Melanoma
Treatment Belinostat, Binimetinib
Clinical Study IdentifierNCT05170334
SponsorH. Lee Moffitt Cancer Center and Research Institute
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

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 participant has no active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
A participant may be treatment naïve. However, prior systemic treatments for metastatic uveal melanoma are allowed. There is no limit on the number of prior regimens for metastatic uveal melanoma. However, no prior therapy with a MEK inhibitor or an HDAC inhibitor
Participant must be free of active brain metastasis by contrast-enhanced CT/MRI scans within 4 weeks prior to enrollment. If known to have prior brain metastases, these must have been adequately managed with standard of care radiation therapy, stereotactic radiosurgery or surgery prior to registration on the study
For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 months after the end of any study drug administration
For males of reproductive potential and/or with female partners of reproductive potential: use of condoms or other methods to ensure effective contraception with partner for 3 months after the last dose of any study drug

Exclusion Criteria

Pregnancy or lactation
Treatment with another investigational drug or other systemic intervention for uveal melanoma within 4 weeks of initiation of study drugs. Participants must not have radiotherapy within the preceding 4 weeks. Participants must have recovered from adverse events due to agents administered more than 4 weeks earlier
Participants must be at least 4 weeks from major surgery and have fully recovered from any effects of surgery and be free of significant detectable infection
Participants must not have other significant medical, surgical, or psychiatric conditions or require any medication or treatment that in the opinion of the investigator may interfere with compliance, make the administration of the study drugs hazardous or obscure the interpretation of AEs
Participants must not have an active infection requiring current treatment with parenteral antibiotics
Cardiac: No evidence of congestive heart failure, symptoms of coronary artery disease, myocardial infarction less than 6 months prior to entry, serious cardiac arrhythmias, or unstable angina
CNS: No history of cerebrovascular accident or transient ischemic attacks within the past 6 months
Serious or non-healing wound, ulcer, or bone fracture
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks of initiating study treatment
Participants with clinically significant cardiovascular or cerebrovascular disease
History of cerebrovascular accident or transient ischemic attack within past 6 months
Uncontrolled hypertension, defined as blood pressure >150/100 mm Hg or systolic BP >180 mm Hg if diastolic blood pressure <90 mm Hg, on at least 2 repeated determinations on separate days within past 3 months
Myocardial infarction, CABG or unstable angina within the past 6 Months
New York Heart Association grade III or greater congestive heart failure (Appendix E), serious cardiac arrhythmia requiring medication, unstable angina pectoris within past 6 months
Clinically significant peripheral vascular disease within past 6 months
Pulmonary embolism, DVT, or other thromboembolic event within past 6 months
PT INR >1.5 unless the patient is on full-dose warfarin
Participants who have other current malignancies are not eligible. Participants with other malignancies are eligible if they have been continuously disease free for > 3 years prior to the time of study registration (enrollment). Participants with prior history at any time of any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, atypical melanocytic hyperplasia or melanoma in situ are eligible. Participants with prior history of basal or squamous skin cancer are eligible
History of retinal vein occlusion, uveitis refractory to ocular therapy, and symptomatic serous retinopathy or retinal pigment epithelial detachments
Active requirement for or a history of corticosteroid systemic therapy in order to treat Interstitial lung disease (ILD) or pneumonitis
The presence of a disorder that may impact absorption of study drugs, such as inability to take oral medication, requirement for IV alimentation, prior gastric resection, treatment for active peptic ulcer confirmed by endoscopy within the past 3 months, active GI bleed, GI malabsorption syndrome
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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