IDE196 (Darovasertib) in Combination with Crizotinib Versus Investigator’s Choice of Treatment as First-line Therapy in HLA-A2 Negative Metastatic Uveal Melanoma

HLA-A2 negative metastatic uveal melanoma

- 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, defined as the time from randomization to date of death due to any cause

• TEAEs, laboratory test abnormalities, ECG and vital sign changes • Study intervention discontinuation due to AEs, • Dose-exposure-response (safety and efficacy) relationship • Plasma concentration profiles and PK parameters including but not limited to Cmax, Ctrough, Tmax, AUC0-t, T1/2, Racc, • PFS, defined as the time from randomization to the first documented date of disease progression or death due to any cause, whichever occurs first, • ORR, defined as the proportion of participants with a CR or a PR as best response • Disease control rate (DCR) (defined as CR or PR, or stable disease [SD] ≥12 weeks) • Best objective response (BOR) • Duration of response (DOR), defined as the time from the first documented evidence of a CR or PR until disease progression or death due to any cause, whichever occurs first • Time to response, • Change from baseline over time and between treatment strategies in EORTC QLQ-C30 and EuroQoL (EQ)-5D-5L scores

No related papers found yet.

Belgium