Actively Recruiting
Phase 2 Trial of Adjuvant Quisinostat in High-Risk Uveal Melanoma
Led by University of Miami · Updated on 2025-06-03
63
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
V
Viriom
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of quisinostat in people with high-risk uveal melanoma, a type of eye cancer. The study aims to see if quisinostat can prevent the cancer from spreading to other parts of the body. This is a phase 2 trial sponsored by the University of Miami, focusing on participants with a specific genetic profile of their tumor that indicates higher risk of spread. Participants will receive quisinostat capsules orally at a dose of 12 mg three times per week during 21-day cycles. Treatment may last for up to 17 cycles, totaling about 51 weeks. After treatment ends, participants will be followed for up to 2 years to monitor if the cancer returns or progresses. The total time involved in the study is about three years. During the study, participants will have regular assessments to track their cancer status and side effects. Researchers will measure how long participants remain free from distant metastasis over 36 months as the main outcome. They will also monitor survival, time before cancer progression, and record any treatment-related side effects for up to 13 months. Participants need to be able to swallow oral medication and have adequate organ function to join.
CONDITIONS
Brief Title
Adjuvant Quisinostat in High-Risk Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of uveal melanoma with a lesion at least 12 mm in largest basal diameter
- Definitive therapy for primary uveal melanoma completed within 183 days before starting study treatment
- High-risk (class 2) uveal melanoma determined by gene expression profiling
- No signs of metastatic disease
- Age greater than 18 years
- ECOG performance status of 0 or 1
- Life expectancy greater than 3 months
- Ability to swallow and retain oral medication with no major gastrointestinal problems
- Adequate organ and marrow function as determined by local lab and physician
- Agreement to use contraception for women of childbearing potential and men during study and 6 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- Additional progressing malignancy or requiring active treatment, except certain skin cancers and stable conditions
- Major surgery or extensive radiotherapy other than for primary uveal melanoma
- Previous adjuvant treatment for uveal melanoma after primary therapy
- Prior use of Histone Deacetylase (HDAC) inhibitors
- Inability to stop medications that strongly inhibit CYP3a4/A5 or CYP2C9 without Sponsor approval
- Use of other investigational drugs within 28 days before study start
- Known allergy to drugs related to quisinostat
- QTcB interval 480 msec or longer or history of long QT syndrome
- Active HIV, Hepatitis B or C infection, except cleared HBV or HCV
- Abnormal cardiac ejection fraction or significant arrhythmia
- Uncontrolled illness including infection, heart failure, unstable angina, or psychiatric/social issues
- Conditions or labs that may interfere with study or patient safety
- Psychiatric or substance abuse disorders interfering with cooperation
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 17 cycles (up to 51 weeks)
Participants receive Quisinostat capsules orally three times per week during each 21-day cycle.
Multiple visits during treatment cycles
Duration - Up to 2 years
Participants are followed for up to 2 years after treatment ends to monitor health and disease progression.
Visits scheduled periodically during follow-up
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
C
Christine Estevez
C
CRS Cutaneous
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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