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RecruitingLast updated: 6 February 2024

This study is evaluating a new targeted therapy in people with primary ocular (uveal) melanoma(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

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

Cancer

Skin Cancers Skin

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

IDEAYA Biosciences

Scientific Title

(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized 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

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.

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.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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