Safety and Efficacy of Everolimus in Metastatic Renal Cell Carcinoma After Failure of First Line Therapy With Sunitinib or Pazopanib (MACS1760)

• Progression-free survival as the time interval between first intake of everolimus and first documented disease progression or death due to any cause [ Time Frame: Baseline, Every 3 months ] [ Designated as safety issue: No ]
  Progression-free survival is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment
• Overall survival of patients treated with everolimus after failure of first-line sunitinib or pazopanib therapy [ Time Frame: Baseline, every 28 days ] [ Designated as safety issue: No ]
  Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause. If a patient is not known to have died, survival will be censored at the date of last contact.
• Overall response rate in patients treated with everolimus after failure of first-line sunitinib or pazopanib therapy [ Time Frame: Baseline, every 3 months ] [ Designated as safety issue: No ]
  Investigator's best overall response rate (ORR) is the proportion of patients with a best overall response of complete response (CR) or partial response (PR) by month 6. ORR will be assessed according to RECIST 1.1 criteria.
• Duration of response in patients treated with everolimus after failure of first-line sunitinib or pazopanib therapy [ Time Frame: Baseline, Every 3 months ] [ Designated as safety issue: No ]
  The duration of overall response (CR or PR) is defined as the time from the first occurrence of a confirmed CR or PR (as per investigator assessment according to RECIST 1.1) until the date of the first documented disease progression or death due to underlying cancer. If a patient has not had an event or when they receive any further anticancer therapy, duration of overall response is censored at the date of last adequate tumor assessment. Duration of response will be displayed only for patients whose best overall response was CR or PR
• Safety of everolimus after failure of first-line sunitinib or pazopanib therapy [ Time Frame: Baseline, Every 28 days ] [ Designated as safety issue: No ]
  The assessment of safety will be based mainly on frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. Other safety data (e.g., electrocardiogram, vital signs) will be considered as appropriate. All safety data will be listed. The safety summary tables will only include assessments collected no later than 28 days after study treatment discontinuation. All safety assessments will be listed and those collected later than 28 days after study treatment discontinuation will be flagged.

Patients with metastatic renal cell carcinoma (mRCC) who have failed first-line therapy with sunitinib or pazopanib will be treated with everolimus. Efficacy and safety of everolimus will be evaluated in theses patients.

Inclusion Criteria:

• Patients with advanced renal cell carcinoma of a histological or cytological confirmation of clear cell renal carcinoma.
• Progression during or after a treatment with sunitinib or pazopanib given in a 1st line treatment situation for mRCC.
• Patients scheduled for treatment with everolimus.
• Patients with at least one measurable lesion at baseline.

Exclusion Criteria:

• Patients who have received >1 prior systemic treatment for their metastatic RCC. Prior systemic treatment in an adjuvant setting is allowed.
• Patients who have previously received systemic mTOR inhibitors (e.g. sirolimus, temsirolimus, everolimus).
• Patients who are using other investigational agents or who had received investigational drugs ≤ 2 weeks prior to study treatment start.
• Patients unwilling or unable to comply with the protocol.

Other protocol-defined inclusion/exclusion criteria may apply.