HLA-A2 negative metastatic uveal melanoma
Conditions
Brief summary
Dose-exposure-response (S&E) relationship; Plasma concentration profiles and PK parameters ;TEAEs, laboratory test abnormalities, ECG and vital sign changes; Study intervention discontinuation due to AEs; PFS, defined as the time from randomization to the first documented date of disease progression or death due to any cause, whichever occurs first; OS (time from randomization to date of death due to any cause
Detailed description
ORR, defined as the proportion of participants with a complete response (CR) or a partial response (PR) as best objective response (BOR), • PFS • ORR, • TEAEs, laboratory test abnormalities, ECG, and vital sign changes. • Study treatment discontinuation due to AEs, • BOR • Disease control rate (DCR), defined as CR or PR, or stable disease (SD) ≥ 12 weeks • DOR, defined as the time from the first documented evidence of a CR or PR until disease progression or death due to the underlying disease, whichever occurs first • Time to response, • PFS, • BOR • ORR • DCR • DOR • Time to response, • Change from baseline over time and between treatment arms in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQoL (EQ)-5D- 5L scores
Interventions
Sponsors
Ideaya Biosciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-exposure-response (S&E) relationship; Plasma concentration profiles and PK parameters ;TEAEs, laboratory test abnormalities, ECG and vital sign changes; Study intervention discontinuation due to AEs; PFS, defined as the time from randomization to the first documented date of disease progression or death due to any cause, whichever occurs first; OS (time from randomization to date of death due to any cause | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR, defined as the proportion of participants with a complete response (CR) or a partial response (PR) as best objective response (BOR), • PFS • ORR, • TEAEs, laboratory test abnormalities, ECG, and vital sign changes. • Study treatment discontinuation due to AEs, • BOR • Disease control rate (DCR), defined as CR or PR, or stable disease (SD) ≥ 12 weeks • DOR, defined as the time from the first documented evidence of a CR or PR until disease progression or death due to the underlying disease, whichever occurs first • Time to response, • PFS, • BOR • ORR • DCR • DOR • Time to response, • Change from baseline over time and between treatment arms in European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and EuroQoL (EQ)-5D- 5L scores | — |
Countries
Belgium, France, Germany, Italy, Netherlands, Poland, Spain
Outcome results
None listed