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Active, Not Recruiting

NCT Number: NCT05907954

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

Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Uveal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Uveal Diseases Uveal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Vincent's Health Sydney, Sydney, New South Wales, Australia

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About this study

Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma (UM) requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 12 months (or maximum benefit) followed by primary local therapy. An additional 6 months of adjuvant treatment may be given to some patients. All patients will have long term follow-up (up to 3 years) to assess visual outcome, disease recurrence, and development of metastatic disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Primary localized uveal melanoma requiring either enucleation or plaque brachytherapy
  • Cohort 3 (patients with small UM tumors) - clinically diagnosed uveal (not iris) melanoma that is < 4 mm in thickness requiring treatment
  • 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 criteria

  • 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

Treatment and study plan

Darovasertib

Drug

Oral, potent, selective inhibitor of Protein Kinase C

Other names: IDE196, LXS196

Primary outcomes

  1. Incidence of Adverse Events (AEs) and significant laboratory abnormalities

    Time frame: from first dose to 28 days after last dose of therapy, approximately 18 months

    Treatment emergent adverse events will be summarized by all AEs, all Grade 3-4-5 AEs, all treatment related AEs, all AEs leading to study drug modifications or discontinuations, all SAEs. Lab results will be summarized by change from baseline values, frequency of newly occurring on-treatment Grade 3 or 4 events; worst on-treatment value compared to baseline.

  2. Cohort 1 (enucleation): Number of patients converted from requiring enucleation to radiation

    Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

    Rate of eye salvage as determined by the ocular oncologist based on tumor response to neoadjuvant therapy

  3. Cohort 2 (plaque brachytherapy): Estimated change in modeled radiation dose

    Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

    Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy

  4. Cohort 3 (patients with small UM tumors): Number of patients with clinical benefit per protocol-defined UM response criteria

    Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

    Proportion of patients with clinical benefit rate (CBR) defined as complete response (CR) + partial response (PR) + stable disease (SD) for ≥ 12 weeks per UM response criteria

Secondary outcomes

  1. Evaluate tumor response to neoadjuvant IDE196

    Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

    Measurement of tumor diameter and thickness before and after neoadjuvant therapy with IDE196, specifically as measured by ocular ultrasound, evaluating largest basal diameter and apical thickness of the uveal melanoma (measured in millimeters)

  2. Assessment of visual acuity loss

    Time frame: from time of primary local therapy to one year after surgery, approximately 12 months

    Best corrected visual acuity loss over time

  3. Rate of local disease recurrence

    Time frame: from date of primary local therapy to end of follow-up, approximately 36 months

    Evaluate uveal melanoma progression or recurrence

  4. Cohort 3 (patients with small UM tumors): Effect of neoadjuvant IDE196 therapy on the natural history of small UM tumors

    Time frame: from first dose of neoadjuvant to primary local therapy, approximately 12 months

    Time from first dose of neoadjuvant to primary local therapy

  5. Cohort 3 (patients with small UM tumors): Efficacy of neoadjuvant IDE196 therapy on small UM tumors

    Time frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 12 months

    Tumor response (complete response and partial response) as measured by protocol-defined UM response criteria

Other outcomes

  1. Rate of metastatic disease

    Time frame: from date of primary local therapy to end of follow-up, approximately 36 months

    Evaluate occurrence of metastatic uveal melanoma

  2. Overall survival

    Time frame: from date of first dose to end of follow-up, approximately 54 months

    Evaluate patient survival status

Sponsors and collaborators

Lead sponsor

IDEAYA Biosciences

Industry

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2030
First posted
Jun 18, 2023
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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