Adrenocortical carcinoma
Conditions
Brief summary
To evaluate the effect of cemiplimab as a maintenance immunotherapy on PFS in patients with advanced ACC with no disease progression after 4–6 EDP-M cycles.
Detailed description
OS: time from the date of the study start to the date of death due to any cause., QoL: EORTC QLQ-C30 questionnaire., AEs and laboratory abnormalities as graded by NCI CTCAE v5.0.
Interventions
DRUGLysodren 500 mg tablets
DRUGLIBTAYO 350 mg concentrate for solution for infusion.
Sponsors
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of cemiplimab as a maintenance immunotherapy on PFS in patients with advanced ACC with no disease progression after 4–6 EDP-M cycles. | — |
Secondary
| Measure | Time frame |
|---|---|
| OS: time from the date of the study start to the date of death due to any cause., QoL: EORTC QLQ-C30 questionnaire., AEs and laboratory abnormalities as graded by NCI CTCAE v5.0. | — |
Countries
Italy
Outcome results
None listed