Uveal Melanoma Clinical Trial
Official title:
(Neo)Adjuvant IDE196 (Darovasertib) in Patients With Localized Ocular Melanoma
Neoadjuvant/adjuvant IDE196 (darovasertib) in patients with primary uveal melanoma
Status | Recruiting |
Enrollment | 82 |
Est. completion date | January 31, 2029 |
Est. primary completion date | January 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Alfred Health | Melbourne | Victoria |
Australia | St. Vincent's Health Sydney | Sydney | New South Wales |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
France | Institute Curie | Paris | |
Germany | Charite Comprehensive Cancer Center | Berlin | |
Germany | University Hospital Essen - West German Cancer Center | Essen | |
Italy | Instituto Nazionale Tumori di Milano | Milano | |
Italy | Instituto Nazionale Tumori IRCCS - Fondazione Pascale | Naples | |
Italy | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | |
Netherlands | Leiden University Medical Center | Leiden | |
United Kingdom | The Clatterbridge Cancer Centre NHS FT | Liverpool | |
United Kingdom | University College London Hospital - NHS Foundation Trust | London | |
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
United States | Sarah Cannon Research Institute | Denver | Colorado |
United States | Duke University Health System | Durham | North Carolina |
United States | The Cancer and Hematology Centers | Grand Rapids | Michigan |
United States | UCLA Medical Center | Los Angeles | California |
United States | Northwell | Manhasset | New York |
United States | University of Miami | Miami | Florida |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Stanford Cancer Institute | Palo Alto | California |
United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
United States | HonorHealth Research Institute | Scottsdale | Arizona |
Lead Sponsor | Collaborator |
---|---|
IDEAYA Biosciences |
United States, Australia, Canada, France, Germany, Italy, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Overall survival | Evaluate patient survival status | from date of first dose to end of follow-up, approximately 44 months | |
Primary | 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 last dose of adjuvant therapy, approximately 12 months | |
Primary | 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 6 months | |
Primary | 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 6 months | |
Secondary | Evaluate tumor response to neoadjuvant IDE196 | Measurement of tumor diameter and thickness before and after neoadjuvant therapy with IDE196, specifically as measured by ocular ultrasound, evaluating largest basal diameter and apical thickness of the uveal melanoma (measured in millimeters) | from first dose of neoadjuvant to end of neoadjuvant therapy, approximately 6 months | |
Secondary | Assessment of visual acuity loss | Best corrected visual acuity loss over time | from time of primary local therapy to one year after surgery, approximately 12 months | |
Secondary | Rate of local disease recurrence | Evaluate uveal melanoma progression or recurrence | from date of primary local therapy to end of follow-up, approximately 36 months | |
Secondary | Rate of metastatic disease | Evaluate occurrence of metastatic uveal melanoma | from date of primary local therapy to end of follow-up, approximately 36 months |
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