Quisinostat for Eye Cancer

Overseen By CRS Cutaneous

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Miami

Must not be taking: CYP3a4/A5 inhibitors

Disqualifiers: Additional malignancy, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 51 weeks

63 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests quisinostat, a new potential drug, to determine if it can prevent the spread of uveal melanoma, a type of eye cancer. Researchers aim to discover how this treatment affects the condition. Individuals with a recent diagnosis of high-risk uveal melanoma who have completed their primary treatment and show no signs of cancer spreading might be suitable candidates. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you cannot be on medications that strongly affect certain liver enzymes (CYP3a4/A5 and CYP2C9) without approval. If you're on such medications, you may need to stop them, but this will be discussed with the trial's Sponsor-Investigator.

Is there any evidence suggesting that quisinostat is likely to be safe for humans?

Research has shown that quisinostat is still under investigation for its safety in treating uveal melanoma, a type of eye cancer. Limited information exists about its side effects, so it remains risky until more is known. Quisinostat is in a Phase 2 trial, indicating it has passed some early safety tests in humans. However, the full extent of how well people tolerate it and what side effects might occur is not yet understood. Participants in this trial will contribute to researchers' understanding of the safety and effects of quisinostat on eye cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Quisinostat is unique because it targets eye cancer by inhibiting histone deacetylases (HDAC), which play a crucial role in regulating gene expression. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, quisinostat offers a more targeted approach, potentially leading to fewer side effects. Researchers are excited because this new mechanism of action can provide a novel way to slow down or stop cancer progression, offering hope for improved outcomes in eye cancer treatment.

What evidence suggests that quisinostat might be an effective treatment for eye cancer?

Research shows that quisinostat might help treat uveal melanoma, a type of eye cancer. In previous studies, quisinostat stopped cancer cells from growing and spreading. This drug targets certain proteins in cancer cells, causing the cells to die. Early results suggest that quisinostat could prevent tumors from spreading in patients with this eye cancer. While more research is needed, these initial findings offer hope for those affected by this condition. Participants in this trial will receive quisinostat treatment for up to 17 cycles, each lasting 21 days, over a total treatment period of up to 51 weeks.

Who Is on the Research Team?

Jose Lutzky, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals with high-risk uveal melanoma, a type of eye cancer. Participants should have completed initial treatment but are at risk of the cancer spreading. Specific eligibility details aren't provided, so interested individuals should contact the study team for full criteria.

Inclusion Criteria

Life expectancy of greater than 3 months.

Ability to understand and the willingness to sign a written informed consent document.

I am older than 18 years.

Exclusion Criteria

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.

Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to quisinostat.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Quisinostat treatment for up to 17 cycles, each cycle lasting 21 days, for a total treatment period of up to 51 weeks

51 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment until disease progression

Up to 2 years

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Quisinostat

Trial Overview The trial is testing quisinostat to see if it can prevent high-risk uveal melanoma from spreading after initial treatment. The effects on patients' conditions will be closely monitored to assess efficacy and safety.

How Is the Trial Designed?

Group I: Quisinostat Treatment Group Experimental Treatment 1 Intervention

Participants will receive up to Quisinostat treatment for up to 17 cycles, each cycle lasting 21 days, for a total treatment period of up to 51 weeks. Participants will be followed for up to 2 years after end of treatment until disease progression. Total participation duration is about three years.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Viriom

Industry Sponsor

Trials

17

Recruited

3,900+

Joseph and Florence Mandel Family Foundation

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06932757

Adjuvant Quisinostat in High-Risk Uveal Melanoma The purpose of this study is to see if giving participants quisinostat will prevent participants' uveal melanoma tumor from spreading.

2. cdn.caymanchem.com cdn.caymanchem.com/cdn/insert/14088.pdf

PRODUCT INFORMATION SAFETY DATA. This material should be considered hazardous until further information becomes available. Do not ingest, inhale, get in eyes, on skin, or on ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11967437/

Meeting Report From the 2023 Cure Ocular Melanoma (CURE ... The primary endpoints are safety, eye preservation (enucleation cohort), and decrease in radiation dose (brachytherapy cohort). Finally, Dr ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)03249-1/fulltext

1702eTiP A phase II trial of quisinostat for high-risk uveal ... Uveal melanoma (UM) comprises 5% of melanomas. Metastases occur in up to 50% of patients, for which here is no curative treatment.

5. cancer.gov cancer.gov/clinicaltrials/NCI-2025-03538

Quisinostat for Preventing Metastasis after Treatment of ... This phase II trial tests how well quisinostat works in preventing tumor cells from spreading (metastasis) in patients with high-risk uveal (eye) melanoma (UM)