Patients with localized renal cell carcinoma
Conditions
Brief summary
Radiographic response defined as a decrease of initial tumour size ≥30% from baseline to the week 12 CT scan, as assessed by the investigator per RECIST v1.1 criteria.
Detailed description
Adverse event (AE) rate, study intervention discontinuation due to AEs, rates of surgery delayed >4 weeks due to AEs from neoadjuvant treatment., 30-day mortality and Clavien-Dindo classification., Patient reported outcomes (PRO) scores for the following domains: EORTC QLQ-C30 global health status/HRQoL (Items 29-30); EORTC QLQ-C30 physical functioning (Items 1-5); EORTC QLQ-C30 role functioning (Items 6-7); FKSI-DRS Subscale (Items 1-9)
Interventions
DRUGLenvatinib
DRUGBelzutifan
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
Sponsors
Vall D Hebron Institute Of Oncology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic response defined as a decrease of initial tumour size ≥30% from baseline to the week 12 CT scan, as assessed by the investigator per RECIST v1.1 criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event (AE) rate, study intervention discontinuation due to AEs, rates of surgery delayed >4 weeks due to AEs from neoadjuvant treatment., 30-day mortality and Clavien-Dindo classification., Patient reported outcomes (PRO) scores for the following domains: EORTC QLQ-C30 global health status/HRQoL (Items 29-30); EORTC QLQ-C30 physical functioning (Items 1-5); EORTC QLQ-C30 role functioning (Items 6-7); FKSI-DRS Subscale (Items 1-9) | — |
Outcome results
None listed