metastatic or locally advanced renal cell carcinoma
Conditions
Brief summary
The primary endpoint of the study is to assess the difference in overall survival (OS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC
Detailed description
To assess the difference in overall survival (OS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC from the beginning of the anti-PD1-based therapy, To assess the difference in progression-free survival (PFS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC, To assess the difference in overall survival (OS) between patients who receive or not the radiotherapy on primary tumor while on therapy with SOC for mRCC among those with primary tumor up to 4 cm at randomization, To assess the difference in progression-free survival (PFS) between patients who receive or not the radiotherapy on primary tumor while on therapy with SOC for mRCC among those with primary tumor up to 4 cm at randomization., To evaluate the safety of the CN and RT on primary tumor among patients receiving SOC for mRCC. Adverse events will be graded according to NCI CTCAE version 5.0, To evaluate the quality of life before and after 8 weeks from the CN or RT on primary tumor among patients receiving SOCfor mRCC evaluated by the questionnaires EQ-5D-5L and FKSI-19 and the surgical complications by the Clavien-Dindo classification, Translational endpoint: To describe as different strategies (CN or RT) affect the patient’s proteome and the correlation between the proteome profile at baseline or its changes with the outcome (i.e.: PFS and OS) to SOC, Translational endpoint: • To describe as the expression of some markers such as PD-L1, PBRM1, BAP1, and presence of CD4 and C8 lymphocytes correlated with the outcome (i.e.: PFS and OS) in the different groups of patients
Interventions
DRUGLENVATINIB
DRUGNIVOLUMAB
DRUGCABOZANTINIB
DRUGAXITINIB
DRUGPEMBROLIZUMAB
DRUGIPILIMUMAB
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to assess the difference in overall survival (OS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the difference in overall survival (OS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC from the beginning of the anti-PD1-based therapy, To assess the difference in progression-free survival (PFS) between patients who receive or not the deferred citoreductive nephrectomy (CN) while on therapy with SOC for mRCC, To assess the difference in overall survival (OS) between patients who receive or not the radiotherapy on primary tumor while on therapy with SOC for mRCC among those with primary tumor up to 4 cm at randomization, To assess the difference in progression-free survival (PFS) between patients who receive or not the radiotherapy on primary tumor while on therapy with SOC for mRCC among those with primary tumor up to 4 cm at randomization., To evaluate the safety of the CN and RT on primary tumor among patients receiving SOC for mRCC. Adverse events will be graded according to NCI CTCAE version 5.0, To eva | — |
Countries
Italy
Outcome results
None listed