Previously untreated advanced uveal melanoma (UM)
Conditions
Brief summary
Overall survival, date of death in relation to study randomization
Detailed description
Safety and tolerability: Incidence and severity of AEs and SAEs; changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF); dose interruptions, reductions, discontinuations, and dose intensity of all administered agents, Serum PK parameters (eg, Cmax, Cmin, Ctrough), • PFS • BOR • DOR • Time to response DCR (defined as CR or PR, or SD ≥ 24 weeks), EQ-5D,5L and EORTC QLQ-C30 change from Baseline over time and between treatment strategies, Assessments of anti-tebentafusp antibody formation
Interventions
DRUGYERVOY 5 mg/ml concentrate for solution for infusion
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGDACARBAZINE
Sponsors
Immunocore Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival, date of death in relation to study randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability: Incidence and severity of AEs and SAEs; changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF); dose interruptions, reductions, discontinuations, and dose intensity of all administered agents, Serum PK parameters (eg, Cmax, Cmin, Ctrough), • PFS • BOR • DOR • Time to response DCR (defined as CR or PR, or SD ≥ 24 weeks), EQ-5D,5L and EORTC QLQ-C30 change from Baseline over time and between treatment strategies, Assessments of anti-tebentafusp antibody formation | — |
Countries
Belgium, France, Italy, Poland, Spain
Outcome results
None listed