Actively Recruiting
Adjuvant Quisinostat in High-Risk Uveal Melanoma
Led by University of Miami · Updated on 2025-06-03
63
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University of Miami
Lead Sponsor
V
Viriom
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to see if giving participants quisinostat will prevent participants' uveal melanoma tumor from spreading. The researchers want to find out the effects that quisinostat has on participants' condition.
CONDITIONS
Official Title
Adjuvant Quisinostat in High-Risk Uveal Melanoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary diagnosis of uveal melanoma with lesion at least 12 mm in largest basal diameter
- Definitive primary therapy completed within 183 days before starting study treatment
- High-risk (class 2) uveal melanoma determined by gene expression profiling
- No evidence of metastatic disease
- Age greater than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy greater than 3 months
- Able to swallow and retain oral medication with no significant gastrointestinal abnormalities
- Adequate organ and marrow function as defined by institutional lab and physician
- Women of childbearing potential and men must use adequate contraception during study and for 6 months after treatment; women must have negative pregnancy test within 14 days before study entry
- Able to understand and willing to sign informed consent
You will not qualify if you...
- Active or progressing additional malignancy requiring treatment, except certain treated skin cancers, in situ cervical cancer, DCIS, asymptomatic thyroid cancer, stable prostate cancer, or cancers with no progression for 2+ years
- Any major surgery or extensive radiotherapy except for primary uveal melanoma treatment
- Previous adjuvant treatment for uveal melanoma after primary therapy
- Prior use of Histone Deacetylase (HDAC) inhibitors
- Cannot discontinue medications that are strong inhibitors of CYP3a4/A5 or CYP2C9 without sponsor approval
- Use of other investigational drugs within 28 days or five half-lives before study treatment
- Known hypersensitivity to drugs related to quisinostat
- QTcB interval of 480 msec or more, or history of long QT syndrome
- Known HIV, hepatitis B, or hepatitis C infection unless cleared
- Abnormal cardiac ejection fraction or significant cardiac arrhythmia
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, or psychiatric/social conditions limiting compliance
- Conditions or abnormalities that could confound trial results or limit participation
- Known psychiatric or substance abuse disorders interfering with trial cooperation
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
C
Christine Estevez
CONTACT
C
CRS Cutaneous
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here