(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 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.

Enrollment: 82 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

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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82 participants in 1 patient group

darovasertib

Experimental group

Description:

IDE196 (darovasertib) oral open label

Treatment:

Drug: Darovasertib