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(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma Summary Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
View Full Description 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.
View Eligibility Criteria Eligibility Criteria 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
Check Your Eligibility
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There are 22 Locations for this study
HonorHealth Research Institute Scottsdale Arizona, 85258, United States
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UCLA Medical Center Los Angeles California, 90024, United States
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Stanford Cancer Institute Palo Alto California, 94305, United States
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Sarah Cannon Research Institute Denver Colorado, 80218, United States
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University of Miami Miami Florida, 33146, United States
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The Cancer and Hematology Centers Grand Rapids Michigan, 49546, United States
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Northwell Manhasset New York, 11030, United States
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Duke University Health System Durham North Carolina, 27710, United States
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Thomas Jefferson University Philadelphia Pennsylvania, 19107, United States
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Sarah Cannon Research Institute Nashville Tennessee, 37203, United States
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University of Texas Southwestern Medical Center Dallas Texas, 75390, United States
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St. Vincent's Health Sydney Sydney New South Wales, 2010, Australia
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Alfred Health Melbourne Victoria, 3004, Australia
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Princess Margaret Cancer Centre Toronto Ontario, M5G2M, Canada
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Institute Curie Paris , , France
Charite Comprehensive Cancer Center Berlin , D-101, Germany
University Hospital Essen - West German Cancer Center Essen , 45147, Germany
Instituto Nazionale Tumori di Milano Milano , 20133, Italy
Instituto Nazionale Tumori IRCCS - Fondazione Pascale Naples , 80131, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome , 00168, Italy
Leiden University Medical Center Leiden , 2333 , Netherlands
The Clatterbridge Cancer Centre NHS FT Liverpool , L7 8Y, United Kingdom
University College London Hospital - NHS Foundation Trust London , NW1 2, United Kingdom
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