Uveal Melanoma
Conditions
Brief summary
The incidence of adverse events (AEs) leading to dose interruption, modification, and discontinuation during neoadjuvant therapy • The incidence of Grade 3 or 4 AEs and clinically significant laboratory abnormalities during neoadjuvant therapy, Cohort 1 – Percentage of patients converted from planned enucleation to eye preserving therapy (e.g., plaque brachytherapy, proton beam radiotherapy, or other) • Cohort 2 –Percentage of patients with a reduction in radiatiAon dose to the fovea, optic disc center, or optic nerve determined by independent central dosimetry modeling, Proportion of subjects with CBR defined as complete response (CR) + partial response (PR) + stable disease (SD) ≥ 12 weeks per the UM response criteria
Detailed description
Time from first dose to time of primary local therapy, Tumor response (CR + PR), Decrease in tumor apical height or bidirectional measurements that include the apical height (tumor thickness) and LBD, Loss of ≥ 15 letters by Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) letter score, Local disease recurrence rate
Interventions
Sponsors
Ideaya Biosciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AEs) leading to dose interruption, modification, and discontinuation during neoadjuvant therapy • The incidence of Grade 3 or 4 AEs and clinically significant laboratory abnormalities during neoadjuvant therapy, Cohort 1 – Percentage of patients converted from planned enucleation to eye preserving therapy (e.g., plaque brachytherapy, proton beam radiotherapy, or other) • Cohort 2 –Percentage of patients with a reduction in radiatiAon dose to the fovea, optic disc center, or optic nerve determined by independent central dosimetry modeling, Proportion of subjects with CBR defined as complete response (CR) + partial response (PR) + stable disease (SD) ≥ 12 weeks per the UM response criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from first dose to time of primary local therapy, Tumor response (CR + PR), Decrease in tumor apical height or bidirectional measurements that include the apical height (tumor thickness) and LBD, Loss of ≥ 15 letters by Early Treatment Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) letter score, Local disease recurrence rate | — |
Countries
France, Germany, Italy, Netherlands
Outcome results
None listed