Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Three-Arm, Randomized, Open-Label Study Of Interferon Alfa Alone, CCI-779 Alone, And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma.
Brief Summary: The primary objective of this study is efficacy. The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 \[Temsirolimus\], administered intravenously \[IV\] once weekly and the combination of CCI-779, administered IV once weekly with Interferon Alfa \[IFN alfa\] subcutaneously \[SC\] three times per week \[TIW\], compared with the overall survival of subjects treated with IFN alfa (SC TIW) alone, in poor-prognosis subjects with advanced RCC.


Options:
A: Inclusion Criteria:

* Histologically confirmed renal cell carcinoma of clear cell histology with metastases
* Evidence of measurable disease by radiographic technique
* Eastern Cooperative Oncology Group \[ECOG\] performance status of 0 or 1

Exclusion Criteria:

* Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
* History of or known brain metastases
* Serious acute or chronic illness or recent history of significant cardiac abnormality
B: Inclusion Criteria:

* This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease,

Exclusion Criteria:

* Subjects with central nervous system (CNS) metastases
* Prior anticancer therapy for RCC
* Prior investigational therapy/agents within 4 weeks of randomization
C: Inclusion Criteria:

* Patients with advanced (unresectable, recurrent or metastatic) RCC
* Patients reasonably likely to benefit from treatment with sorafenib as a single agent therapy
* Patients with an ECOG performance status of 0-2
* Patients who will not require other systemic anticancer therapy (except for bisphosphonates) while taking sorafenib
* Patients with vascular diseases such as wet macular degeneration, vasculitis, or new peptic ulcer, may be enrolled but require close monitoring in accordance with established medical practice

Exclusion Criteria:

* Patients who are currently enrolled in, are eligible for, or have access to, any other sorafenib clinical trial
* Patients who have participated in any other sorafenib trial
* Patients who have had prior therapy with investigational agent(s) within the last four weeks prior to study entry
* Life expectancy of less than two months
* Patients with cardiac arrhythmias greater than grade 1 NCI CTCAE, Version 3.0
* Patients with active coronary artery disease or ischemia
* Patients with Child-Pugh class C hepatic impairment
* Patients with severe renal impairment or who require dialysis
* Patients with active uncontrolled hypertension
* Patients with recent or active bleeding diathesis
D: Inclusion Criteria:

* Patients with metastatic carcinoma and with histological or cytological confirmation of clear cell RCC (tissue from the original diagnosis of renal cell cancer is acceptable).
* The date of progression on sunitinib and/or sorafenib must be within 6 months.
* Patients may have received one or both agents
* Prior therapy with cytokines (i.e., IL-2, Interferon) and/or VEGF-ligand inhibitors (i.e., bevacizumab) are permitted.
* Prior vaccine therapy in the adjuvant setting is permitted.
* Patients with at least one measurable lesion at baseline as per the Response evaluation criteria in solid tumors (RECIST) criteria, either on physical exam or as determined by Computer Tomography (CT) Scan or Magnetic Resonance Imaging (MRI).
* Patients with a Karnofsky Performance Status ≥70%.
* Adequate bone marrow, liver and renal function.
* Patients with a life expectancy ≥ 3 months.
* Women of childbearing potential must have had a negative serum or urine pregnancy test 48 hours prior to the administration of the first study treatment.
* Patients who give a written informed consent obtained according to local guidelines

Exclusion Criteria:

* Patients currently receiving chemotherapy, immunotherapy, or radio-therapy or who have received these within 4 weeks of study entry
* Patients who have previously received mTOR inhibitors.
* Patients with a known hypersensitivity to RAD001 or other rapamycins (sirolimus, temsirolimus) or to its excipients.
* Patients with untreated CNS metastases or who are neurologically unstable despite treatment of the CNS metastases. (Patients with treated CNS metastases, who are neurologically stable off of corticosteroids, are eligible to enter study).
* Patients receiving chronic treatment with corticosteroids or another immunosuppressive agent
* Patients with a known history of HIV seropositivity.
* Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
* Patients who have any severe and/or uncontrolled medical conditions
* Patients who have a history of another primary malignancy ≤ 3 years, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes.
* Patients who are using other investigational agents or who had received investigational drugs ≤ 4 weeks prior to randomization
* Patients unwilling to or unable to comply with the protocol

Other protocol-defined inclusion/exclusion criteria may apply.

Answer: B