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

Phase 2RecruitingNCT05907954

IDEAYA Biosciences160 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Uveal Melanoma

Interventions

DarovasertibDRUG

Oral, potent, selective inhibitor of Protein Kinase C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (24)

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs) and significant laboratory abnormalities

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.

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

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

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

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

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

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

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

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

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

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

Secondary Outcomes

Evaluate tumor response to neoadjuvant IDE196

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)

Central Contacts

IDEAYA Clinical Trials

CONTACT

+1-855-433-2246 IDEAYAClinicalTrials@ideayabio.com

Jasgit Sachdev, MD

CONTACT

jsachdev@ideayabio.com

Data from ClinicalTrials.gov

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