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Prednisone + Everolimus: Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason.

A treatment cycle consists of 28 days.

Prednisone + Everolimus

Ugo De Giorgi, MD

This is a multicenter prospective study that includes all patients with metastatic Renal Cell Cancer (RCC) pre- treated with VEGFR TKI in eight Italian cancer centers.

Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason.

A treatment cycle consists of 28 days.

Title Phase II study of oral PRednisone 5 mg bid plus EVerolimus in patients with metastatic renal cell cancer after failure of vascular endothelial growth factor receptor-tyrosine kinase inhibitor (PREV study).

Short Title/ Acronym PREV Protocol Code IRST189.04 Phase Phase 2 Study Design This is a multicenter prospective study that includes all patients with metastatic RCC pre- treated with VEGFR TKI in eight Italian cancer centers.

Study Duration 2 years of recruitment and 1 year of follow-up Study Center(s) multi-center: 8 centers involved

Objectives Primary objective:

To evaluate the safety and tolerability of prednisone 5 mg bid and everolimus 10 mg/day in RCC.

Secondary objectives:

To evaluate the activity and the clinical outcome of these patients.

Exploratory objectives:

To evaluate the influence of prednisone on trough concentration of everolimus and correlation with the incidence of side effects, in particular stomatitis and non-infectious pneumonitis.

Infiammation markers such as pentraxin 3 (PTX3), IL-6, TGF-β and neutrophil-lymphocyte ratio will be correlated with clinical outcome (ORR, PFS, OS).

Number of Subjects 42 subjects Diagnosis and Main Inclusion Criteria Patients with mRCC who failed at least one VEGFR TKI.

Main Inclusion Criteria:

* Patients with renal cell carcinoma who failed at least one VEGFR TKI
* Patients with adequate bone marrow function
* Patients with adequate liver function
* Patients with adequate renal function Diagnosis and Main Inclusion Criteria (continued) Main exclusion criteria:
* CNS disease OR patients with presence or history of central nervous system (CNS) lymphoma
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent (except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg for adrenal insufficiency). However, patients receiving corticosteroids must be on a stable dose for ≥ 4 weeks prior to the first dose of everolimus. Topical or inhaled corticosteroids are permitted.
* Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
* Patients with uncontrolled hyperlipidemia (≥ Grade 3 hyperlipidemia despite optimal supportive medical therapy)
* Patients with an active, bleeding diathesis
* Previous organ transplantation
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study Study Product, Dose, Route, Regimen and duration of administration Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason.

A treatment cycle consists of 28 days. Reference therapy Not applicable Statistical Methodology This is a multicenter prospective study that includes all patients with metastatic RCC pre- treated with VEGFR TKI in eight Italian cancer centers.

The study will be analyzed on an intent-to-treat basis. Secondary parameters will be analyzed exploratively for the intent-to-treat population.

PRednisone Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of VEGFR -TKI

Phase II Study of Oral PRednisone 5 mg Bid Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of Vascular Endothelial Growth Factor Receptor-tyrosine Kinase Inhibitors

to evaluate the incidence of grade ≥ 2 stomatitis and non-infectious pneumonitis in RCC patients treated with prednisone 5 mg bid and everolimus 10 mg/day.

the sum of partial responses plus complete responses

time from the date of starting of the treatment to the date of the first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.

time from the date of starting of the treatment to the date of the death due to any cause. Patients living at the time of analysis will be censored at their last date of tumor evaluation.

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PRednisone Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of VEGFR -TKI	NCT02479490	Metastatic Rena...	Prednisone + Ev...	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
PRednisone Plus EVerolimus in Patients With Metastatic Renal Cell Cancer After Failure of VEGFR -TKI	NCT02479490	Metastatic Rena...	Prednisone + Ev...	18 Years -	Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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