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

• ClinicalTrials.gov Identifier: NCT05907954
• Recruitment Status: Recruiting
• First Posted: June 18, 2023
• Last Update Posted: March 28, 2024
• Sponsor: IDEAYA Biosciences
• Information provided by (Responsible Party): IDEAYA Biosciences

Tracking Information

• First Submitted Date: June 6, 2023
• First Posted Date: June 18, 2023
• Last Update Posted Date: March 28, 2024
• Actual Study Start Date: July 3, 2023
• Estimated Primary Completion Date: January 31, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 14, 2023)

• 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.
• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 14, 2023)

• 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)
• 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
• 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
• 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: June 14, 2023)

Overall survival [ Time Frame: from date of first dose to end of follow-up, approximately 44 months ]

Evaluate patient survival status

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: (Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
• Official Title: (Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
• Brief Summary: Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
• 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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Uveal Melanoma

Intervention

Drug: Darovasertib

Oral, potent, selective inhibitor of Protein Kinase C

Other Names:

• IDE196
• LXS196

Study Arms

Experimental: darovasertib

IDE196 (darovasertib) oral open label

Intervention: Drug: Darovasertib

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 14, 2023): 82
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 31, 2029
• Estimated Primary Completion Date: January 31, 2026 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: IDEAYA Clinical Trials; 1 650-534-3616; IDEAYAClinicalTrials@ideayabio.com

Contact: Jasgit Sachdev, MD; jsachdev@ideayabio.com

• Listed Location Countries: Australia, Canada, France, Germany, Italy, Netherlands, United Kingdom, United States

Administrative Information

• NCT Number: NCT05907954
• Other Study ID Numbers: IDE196-009
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: IDEAYA Biosciences
• Original Responsible Party: Same as current
• Current Study Sponsor: IDEAYA Biosciences
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jasgit Sachdev, MD; IDEAYA Biosciences

• PRS Account: IDEAYA Biosciences
• Verification Date: November 2023