IDE196-009
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma.
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.
Klinische Settings
Indikation: Aderhautmelanom
Therapiesituation: adjuvant / neoadjuvant
Einschlusskriterien
- 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
Ausschlusskriterien
- 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
Links
An der Studie beteiligte Zentren
Zentrum
Charité Berlin - Klinik für Augenheilkunde
Campus Benjamin Franklin Hindenburgdamm 30
12200 Berlin
Deutschland
Kontakt
Frau Julia Koester-Schuster studien-augenklinik-cfb@charite.de
Zentrum
Innere Klinik für Tumorforschung
Universitätsmedizin Essen Hufelandstraße 55
45147 Essen
Deutschland
Kontakt
Frau Dr. Halime Kalkavan halime.kalkavan@uk-essen.de