RECRUITING

Adjuvant Quisinostat in High-Risk Uveal Melanoma

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-06-01

Study Completion:2030-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06932757

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:19 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Christine Estevez

CONTACT

305-243-8376

cme101@med.miami.edu

CRS Cutaneous

CONTACT

305-243-0326

CRSCutaneous@miami.edu

Principal Investigator

Jose Lutzky, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Jose Lutzky, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-01

Study Completion Date2030-06-01

Study Record Updates

Study Start Date2025-06-01

Study Completion Date2030-06-01

Terms related to this study

Additional Relevant MeSH Terms

Uveal Melanoma