Previously treated non-ocular advanced melanoma
Conditions
Brief summary
Overall survival
Detailed description
ctDNA reduction on treatment relative to baseline, Incidence and severity of AEs, SAEs, and changes from baseline in laboratory parameters, vital signs, and ECGs Dose interruptions reductions, dose intensity and discontinuation of all administered agents, Incidence of Grade ≥ 2 CRS based on ASTCT grade, time to onset, duration of defined CRS component events, and incidence of prolonged hospitalization, Patient-reported symptoms and health-related quality of life according to the EORTC-QLQ-C30 and general health status according to the EQ-5D-5L questionnaires., Tebentafusp PK parameters (eg, Cmax, Tmax, Cavg, t1/2), Incidence of anti-tebentafusp antibodies
Interventions
DRUGDEXAMETHASONE PHOSPHATE
DRUGDEXAMETHASONE
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGPARACETAMOL
DRUGDIPHENHYDRAMINE
Sponsors
Immunocore Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| ctDNA reduction on treatment relative to baseline, Incidence and severity of AEs, SAEs, and changes from baseline in laboratory parameters, vital signs, and ECGs Dose interruptions reductions, dose intensity and discontinuation of all administered agents, Incidence of Grade ≥ 2 CRS based on ASTCT grade, time to onset, duration of defined CRS component events, and incidence of prolonged hospitalization, Patient-reported symptoms and health-related quality of life according to the EORTC-QLQ-C30 and general health status according to the EQ-5D-5L questionnaires., Tebentafusp PK parameters (eg, Cmax, Tmax, Cavg, t1/2), Incidence of anti-tebentafusp antibodies | — |
Countries
Austria, Belgium, France, Germany, Italy, Poland, Spain
Outcome results
None listed