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

Ideaya Biosciences

Status and phase: Enrolling; Phase 2

Conditions: Uveal Melanoma

Treatments: Drug: Darovasertib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05907954

IDE196-009

Details and patient eligibility

About

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

Full description

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

darovasertib

Experimental group

Description:

IDE196 (darovasertib) oral open label

Treatment:

Drug: Darovasertib