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Trial record 1 of 1 for:    05907954
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(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma

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ClinicalTrials.gov Identifier: NCT05907954
Recruitment Status : Recruiting
First Posted : June 18, 2023
Last Update Posted : May 13, 2024
Sponsor:
Information provided by (Responsible Party):
IDEAYA Biosciences

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

Condition or disease Intervention/treatment Phase
Uveal Melanoma Drug: Darovasertib Phase 2

Detailed Description:
Phase 2 multi-center open-label IDE196 study in patients with primary uveal melanoma requiring either enucleation or plaque brachytherapy. Patients will be treated in neoadjuvant setting up to 6 months (or maximum benefit) 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 development of metastatic disease.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: (Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Actual Study Start Date : July 3, 2023
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : January 31, 2029


Arm Intervention/treatment
Experimental: darovasertib
IDE196 (darovasertib) oral open label
Drug: Darovasertib
Oral, potent, selective inhibitor of Protein Kinase C
Other Names:
  • IDE196
  • LXS196




Primary Outcome Measures :
  1. Incidence of Adverse Events (AEs) and significant laboratory abnormalities [ Time Frame: from first dose to last dose of adjuvant therapy, approximately 12 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 6 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 6 months ]
    Change in modeled radiation dose at critical eye structures before and after neoadjuvant therapy


Secondary Outcome Measures :
  1. Evaluate tumor response to neoadjuvant IDE196 [ Time Frame: from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 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. 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


Other Outcome Measures:
  1. Overall survival [ Time Frame: from date of first dose to end of follow-up, approximately 44 months ]
    Evaluate patient survival status



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05907954


Contacts
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Contact: IDEAYA Clinical Trials 1 650-534-3616 IDEAYAClinicalTrials@ideayabio.com
Contact: Jasgit Sachdev, MD jsachdev@ideayabio.com

Locations
Show Show 23 study locations
Sponsors and Collaborators
IDEAYA Biosciences
Investigators
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Study Director: Jasgit Sachdev, MD IDEAYA Biosciences
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Responsible Party: IDEAYA Biosciences
ClinicalTrials.gov Identifier: NCT05907954    
Other Study ID Numbers: IDE196-009
First Posted: June 18, 2023    Key Record Dates
Last Update Posted: May 13, 2024
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IDEAYA Biosciences:
Uveal Melanoma
Plaque brachytherapy
Enucleation
Neoadjuvant
Adjuvant
Protein Kinase C
Ophthalmology
Ocular Oncology
Darovasertib
IDE196
Ocular melanoma
Choroid melanoma
Plaque
Brachytherapy
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Skin Diseases