Neoadjuvant Darovasertib in Primary Uveal Melanoma

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Neoadjuvant Darovasertib in Primary Uveal Melanoma

Study Purpose

This is a Phase 3, randomized, multi-center, open-label study of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (OptimUM-10)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Primary non-metastatic uveal melanoma.

- Able and willing to provide written, informed consent before initiation of any study-related procedures, and in the opinion of the Investigator, to comply with all study requirements.

- ECOG 0 or 1.

- Adequate organ function.

Exclusion Criteria:

- Previous treatment for UM.

- Evidence of metastatic UM.

- Attributes that necessitate enucleation regardless of response to therapy.

- Evidence of progressive secondary underlying ocular disease that would confound longitudinal VA assessments.

- Presence of a malignant disease other than the one being treated in this study

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07015190
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	IDEAYA Biosciences
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Austria, Belgium, Canada, Czechia, Denmark, Estonia, France, Germany, Greece, Israel, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Uveal Melanoma

Additional Details

The study is divided into 2 cohorts of patients with primary uveal melanoma requiring either plaque brachytherapy or enucleation. In cohort 1, patients in the treatment arm will receive neoadjuvant darovasertib followed by plaque brachytherapy compared to immediate plaque brachytherapy (control arm). In cohort 2, the treatment arm will receive neoadjuvant darovasertib followed by definitive primary local therapy (i.e., plaque brachytherapy, proton beam radiation, or enucleation). Subjects in the control arm will go onto immediate enucleation. Subjects will then receive primary local therapy following neoadjuvant darovasertib. All patients will be followed for up to 3 years to assess longer term outcomes such as vision and tumor recurrence.

Arms & Interventions

Arms

Experimental: Treatment Arm

Darovasetib followed by definitive primary local therapy (i.e., PB, proton beam radiation, or enucleation)

Active Comparator: Control Arm

Immediate Primary Local therapy

Interventions

Drug: - Darovasertib

Dosed orally, twice daily (28-day/ cycle

Procedure: - Primary Local Therapy

Plaque Brachytherapy or Enucleation

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Mayo Clinic Scottsdale - PPDS, Scottsdale 5313457, Arizona 5551752

Status

Not yet recruiting

Address

Mayo Clinic Scottsdale - PPDS

Scottsdale 5313457, Arizona 5551752, 85259

Site Contact

Odette Houghton, MD Principal Investigator

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