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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

• Definitive therapy of the primary UM must have been completed within 183 days of initiating protocol therapy.

• High-risk (class 2) UM as determined by gene expression profiling (GEP; DecisionDx-UM, Castle Biosciences Inc., Friendswood, TX).

• No evidence of metastatic disease.

• Patients aged \>18 years.

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

• Life expectancy of greater than 3 months.

• 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.

• Adequate organ and marrow function as defined by the local institutional lab and treating physician.

⁃ 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.

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

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Christine Estevez
cme101@med.miami.edu
305-243-8376
Backup
CRS Cutaneous
CRSCutaneous@miami.edu
305-243-0326
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2030-05-27
Participants
Target number of participants: 63
Treatments
Experimental: Quisinostat Treatment Group
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.
Related Therapeutic Areas
Sponsors
Collaborators: Joseph and Florence Mandel Family Foundation, Viriom
Leads: University of Miami

This content was sourced from clinicaltrials.gov