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Metastatic Uveal MelanomaPhase 2NCT05170334

Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma

A Phase 2 study testing Binimetinib and Belinostat in people with Metastatic Uveal Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Uveal Melanoma
What is being tested?
Binimetinib and Belinostat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
15 Dec 2021to Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase II Study of Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma

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.

Being tested
Binimetinib, Belinostat
Keywords
Eye Cancer
Medical subject headings
Uveal Melanoma, Eye Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BinimetinibDrug

    Also called Mektovi, ARRY-162

    Binimetinib will be given at 45 mg orally twice daily during each cycle of 21 days, for up to 16 cycles.

  • BelinostatDrug

    Also called Beleodaq

    Belinostat will be administered IV at 1,000 mg/m2 daily on days 1 to 5 every 21 days during each 21 day cycle, for up to 16 cycles

Study groups in NCT05170334
Study groupRoleWhat they receive
Binimetinib + BelinostatExperimentalParticipants will receive binimetinib by mouth two times a day, every day during each cycle. Each cycle will last for 21 days. Participants will receive belinostat by intravenous infusion on days 1 through 5 of each cycle.
Receives: Drug: Binimetinib; Drug: Belinostat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Overall Response Rate (ORR) defined as proportion of patients to have achieved a complete or partial response per RECIST v1.1 criteria.

    Measured: Up to 5 years

Secondary outcomes (2)

  1. Progression Free Survival

    Progression Free Survival (PFS) is defined as the length of time from start of study treatment to the earlier of the first documentation of disease progression or death from any cause.

    Measured: Up to 5 years

  2. Overall Survival

    Overall Survival (OS) is defined as the length of time from start of treatment to date of death from any cause.

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2021
  2. Study start15 Dec 2021
  3. Primary completion1 Dec 2025
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05170334
Sponsor's protocol ID
MCC-20955
Status last verified
Mar 2026
First submitted
9 Dec 2021
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Binimetinib and Belinostat in people with Metastatic Uveal Melanoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05170334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.

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