Adjuvant Quisinostat in High-Risk Uveal Melanoma
ConditionUveal Melanoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorUniversity of Miami
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Any major surgery or extensive radiotherapy except that which is required for definitive treatment of primary UM.
Previous adjuvant treatment for UM after definitive primary tumor therapy.
History of prior Histone Deacetylase (HDAC) inhibitor use.
Trial design
Treatments tested in this trial
- Quisinostat
Treatment groups
63 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Miami
Lead sponsor
Viriom
Collaborator
Joseph and Florence Mandel Family Foundation
Collaborator
Source ClinicalTrials.gov