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

NCT05907954 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IDE196-009
• Study Type: interventional
• Target: 160
• Locations: 7 countries
• Sites: 18

Brief Summary

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

Conditions

Uveal Melanoma

Keywords

Uveal Melanoma; Plaque brachytherapy; Enucleation; Neoadjuvant; Adjuvant; Protein Kinase C; Ophthalmology; Ocular Oncology; Darovasertib; IDE196; Ocular melanoma; Choroid melanoma; Plaque; Brachytherapy

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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

  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

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

Secondary Outcomes (5)

• Evaluate tumor response to neoadjuvant IDE196

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

• Assessment of visual acuity loss

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

• Rate of local disease recurrence

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

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

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

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

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

Other Outcomes (2)

• Rate of metastatic disease

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

• Overall survival

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

Study Arms (1)

darovasertib

EXPERIMENTAL

IDE196 (darovasertib) oral open label

Drug: Darovasertib

Interventions

Darovasertib DRUG

Oral, potent, selective inhibitor of Protein Kinase C

Also known as: IDE196, LXS196

darovasertib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IDEAYA Biosciences: lead

Study Sites (18)

HonorHealth Research Institute

Scottsdale, Arizona, 85258, United States

Location

Moores Cancer Center

La Jolla, California, 92093, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94305, United States

Location

University of Miami

Miami, Florida, 33146, United States

Location

The Cancer and Hematology Centers

Grand Rapids, Michigan, 49546, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Northwell

Manhasset, New York, 11030, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

St. Vincent's Health Sydney

Sydney, New South Wales, 2010, Australia

Location

Alfred Health

Melbourne, Victoria, 3004, Australia

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G2M9, Canada

Location

Institute Curie

Paris, 75005, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Fondazione IRCCS Istituto Nazionale Tumori

Milan, 20133, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Uveal Melanoma; Plaque, Amyloid

Condition Hierarchy (Ancestors)

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

Study Officials

• Jasgit Sachdev, MD

  IDEAYA Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 18, 2023
• Study Start: July 3, 2023
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2030
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2); DE (1); FR (1); CA (1); IT (2); US (10); NL (1)