Trial purpose
Cancer treatment
Tumor type
Skin
Age
18+
Clinical summary
Summary
This study is recruiting people with primary ocular (uveal) melanoma requiring either enucleation or plaque brachytherapy.
Eligible participants will be treated in the neoadjuvant setting with an oral targeted therapy called darovasertib (also known as IDE196) for up to 6 months followed by primary local therapy.
An additional 6 months of adjuvant treatment to follow with long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and developement of metastatic disease.
Conditions
This trial is treating patients with localised ocular melanoma
Eligibility
Inclusion
- Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
- Able to dose orally
- ECOG Performance status of 0-1
- No other significant underlying ocular disease
- Adequate organ function
- Not pregnant/nursing or planning to become pregnant. Willing to use birth control
Exclusion
- Previous treatment with a Protein Kinase C (PKC) inhibitor
- Concurrent malignant disease
- Active HIV infection or Hep B/C
- Malabsorption disorder
- Unable to discontinue prohibited medication
- Impaired cardiac function or clinically significant cardiac disease
- Any other condition which may interfere with study interpretation or results
Inclusion
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You are able to swallow medication by mouth.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
IDEAYA Biosciences
Scientific Title
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
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