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Can a pill prevent eye cancer spread? new trial aims to find out

NCT ID NCT06932757

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether the drug quisinostat can prevent uveal melanoma from spreading in high-risk patients. About 63 people who have completed initial treatment for their eye tumor will take quisinostat capsules three times a week. Researchers will track how long participants stay free of distant metastases.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Quisinostat (a drug taken as a capsule three times a week)
What this could lead to
If it works, this could help prevent uveal melanoma from spreading to other parts of the body in high-risk patients.
What could go wrong
This is a small, early-phase trial with only 63 participants. The drug may not prevent metastasis, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 63 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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