Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma

NCT05170334 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MCC-20955
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Metastatic Uveal Melanoma

Keywords

Eye Cancer

Outcome Measures

Primary Outcomes (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.

  Up to 5 years

Secondary Outcomes (2)

• Progression Free Survival

  Up to 5 years

• Overall Survival

  Up to 5 years

Study Arms (1)

Binimetinib + Belinostat

EXPERIMENTAL

Participants 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.

Drug: Binimetinib; Drug: Belinostat

Interventions

Binimetinib DRUG

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

Also known as: Mektovi, ARRY-162

Binimetinib + Belinostat

Belinostat DRUG

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

Also known as: Beleodaq

Binimetinib + Belinostat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Pfizer: collaborator
• Acrotech Biopharma Inc.: collaborator

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Uveal Melanoma; Eye Neoplasms

Interventions

binimetinib; belinostat

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Ahmad Tarhini, MD, PhD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: December 27, 2021
• Study Start: December 15, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 1, 2025

Record last verified: 2025-09

Locations

US (1)