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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Adjuvant Quisinostat in High-Risk Uveal Melanoma

Phase 2 Trial of Adjuvant Quisinostat in High-Risk Uveal Melanoma

Adjuvant Quisinostat in High-Risk Uveal Melanoma (NCT06932757) is a Phase 2 interventional studying Uveal Melanoma, sponsored by University of Miami. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Uveal Melanoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 63 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Uveal Melanoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Primary diagnosis of uveal melanoma (UM) with a lesion of at least 12 mm in largest basal diameter (LBD) as clinically determined by the treating Investigator. Cytologic determination of diagnosis is not required. Size is based on clinical assessment (e.g., by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy. 2. Definitive therapy of the primary UM must have been completed within 183 days of initiating protocol therapy. 3. High-risk (class 2) UM as determined by gene expression profiling (GEP; DecisionDx-UM, Castle Biosciences Inc., Friendswood, TX). 4. No evidence of metastatic disease. 5. Patients aged \>18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7. expected to live at least 3 months. 8. Ability to swallow and retain orally administered medication and no clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels. 9. Adequate organ and marrow function as defined by the local institutional lab and treating physician. 10. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 6 months after completion of quisinostat administration. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to study entry. 11. Ability to understand and the willingness to sign a written willing to sign a consent form document. Who Should NOT Join This Trial: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Primary diagnosis of uveal melanoma (UM) with a lesion of at least 12 mm in largest basal diameter (LBD) as clinically determined by the treating Investigator. Cytologic determination of diagnosis is not required. Size is based on clinical assessment (e.g., by ultrasound or direct ophthalmoscopy) prior to enucleation or radiation therapy. 2. Definitive therapy of the primary UM must have been completed within 183 days of initiating protocol therapy. 3. High-risk (class 2) UM as determined by gene expression profiling (GEP; DecisionDx-UM, Castle Biosciences Inc., Friendswood, TX). 4. No evidence of metastatic disease. 5. Patients aged \>18 years. 6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7. Life expectancy of greater than 3 months. 8. Ability to swallow and retain orally administered medication and no clinically significant gastrointestinal abnormalities that may alter absorption, such as malabsorption syndrome or major resection of the stomach or bowels. 9. Adequate organ and marrow function as defined by the local institutional lab and treating physician. 10. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation until 6 months after completion of quisinostat administration. Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days prior to study entry. 11. Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Additional malignancy that is progressing or requires active treatment. Exceptions include the following cancers: basal cell carcinoma or squamous cell carcinoma of the skin that has undergone potentially curative therapy, in situ cervical cancer, ductal carcinoma in situ (DCIS), incidentally discovered asymptomatic thyroid cancer, elevated levels of prostate-specific antigen (PSA) stable on hormonal therapy with no otherwise detectable disease, and a previous diagnosis of malignancy that has shown no evidence of disease progression for 2 years or longer. 2. Any major surgery or extensive radiotherapy except that which is required for definitive treatment of primary UM. 3. Previous adjuvant treatment for UM after definitive primary tumor therapy. 4. History of prior Histone Deacetylase (HDAC) inhibitor use. 5. Patients that cannot be taken off medications that are potent inhibitors of cytochrome (CYP) 3a4/A5 (CYP3a4/A5) and CYP2C9. Inclusion of these patients and of patients on warfarin will require discussion and approval by the Sponsor-Investigator prior to enrollment. 6. Use of other investigational drugs within 28 days or five half-lives, whichever is shorter, with a minimum of 14 days from the last dose preceding the first dose of study treatment and during the study. 7. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to quisinostat. 8. A QT interval corrected for heart rate using the Bazett's formula (QTcB) ≥ 480 msec or history of long QT syndrome. 9. Known Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection except for patients with cleared HBV and HCV infection demonstrated by undetectable viral levels by polymerase chain reaction (PCR). HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with quisinostat. 10. Patients with a cardiac ejection fraction outside of the normal range as defined by institutional standards or with a history of clinically significant cardiac arrhythmia as determined by a cardiologist. 11. Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, New York Heart Association (NYHA) Classifications 2-4, or psychiatric illness/social situations that would limit compliance with study requirements. 12. History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or that makes participation in the trial to be not in the best interest of the patient in the opinion of the treating Investigator. 13. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 14. Impaired decision-making capacity.

Treatments Being Tested

DRUG

Quisinostat

Participants will receive 12 mg of Quisinostat via capsule to be taken orally three times per week of each 21 day cycle.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University of Miami
Miami, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06932757), the sponsor (University of Miami), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06932757 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06932757?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06932757?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06932757. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06932757. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.