Adjuvant Quisinostat in High-Risk Uveal Melanoma

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06932757
Phase
PHASE2
Status
Recruiting
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Conditions

  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
May 2025
Primary completion
May 27, 2030
Completion
May 27, 2030

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Distant metastasis-free survival (DMFS) Rate [ Time Frame: Up to 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Christine Estevez
[email protected]
305-243-8376
CRS Cutaneous
[email protected]
305-243-0326
Jose Lutzky, MD (PRINCIPAL_INVESTIGATOR)

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University of Miami· Miami, FL

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