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

Sponsor

IDEAYA Biosciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05907954

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jan 31, 2026

Anticipated Study Completion Date :

Jan 31, 2029

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: darovasertib

IDE196 (darovasertib) oral open label

Drug: Darovasertib

Oral, potent, selective inhibitor of Protein Kinase C

Other Names:

IDE196

LXS196

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events (AEs) and significant laboratory abnormalities [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 [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 [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

Evaluate tumor response to neoadjuvant IDE196 [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 [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 [from date of primary local therapy to end of follow-up, approximately 36 months]
Evaluate uveal melanoma progression or recurrence
Rate of metastatic disease [from date of primary local therapy to end of follow-up, approximately 36 months]
Evaluate occurrence of metastatic uveal melanoma

Other Outcome Measures

Overall survival [from date of first dose to end of follow-up, approximately 44 months]
Evaluate patient survival status

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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