Clinical outcomes of advanced renal cell carcinoma following disease progression to programmed death (PD)-1, PD-L1 inhibitors (I-O). Ugo De Giorgi Daniele Santini Delia De Lisi IRST IRCSS, Meldola Università Campus Bio-Medico, Roma

Background In advanced renal cell carcinoma , target therapy (TT) with anti- VEGR and mTOR inhibitor is the standard of care. The approval of the use of immune checkpoint inhibitor Nivolumab, who showed a longer Overall survival (OS) over everolimus in previously treated patients, has dramatically change the therapeutic scenario 1. Combination of immunotherapy alone or in association with TT has recently showed promising results 2,3,4.

Rationale Despite recent encouraging results Overall Survival remains still poor and recurrence to TT after Nivolumab progression is needed. No data about: - the appropriate therapeutic sequence after I-O progression. - potential predictive/prognostic clinical biomarkers who can identify the best patients therapeutic selection.

Secondary Objectives: Clinical outcomes of advanced renal cell carcinoma following disease progression to programmed death (PD)-1, PD-L1 inhibitors (I-O). This is a multicenter observational retrospective study ideated to identify an Italian registry of the outcome of RCC patients who progress after the immune checkpoint inhibitor Nivolumab or other type of I-O. Primary endpoint: - To evaluate Progression Free Survival (PFS) of RCC patients after I-O progression. PFS will be defined as the time since start a new TT to radiological/clinical progression.   Secondary Objectives: - To evaluate which TT after I-O progression is preferred by clinician in the real word scenario. To collect important data considered as potential clinical biomarkers of patient selection. To collect important clinical and outcome data regarding patients who continued the I-O therapy beyond progression.

Inclusion and exclusion criteria Inclusion criteria: Metastatic renal cell carcinoma patients who progress after I-O   Exclusion criteria: Metastatic renal cell carcinoma patients included in Nivolumab Expanded access programme.

Stato attuale dello studio Settembre 2017: Il Meet-Uro ha approvato lo studio Settembre 2017: sottomissione all’ufficio sperimentazioni cliniche , a seguire successiva sottomissione al Comitato Etico (CE) del Campus Bio- Medico di Roma Successiva sottomissione al CE degli altri centri partecipanti

Grazie per l’attenzione