Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Open-Label, Phase 3 Study of Nivolumab (BMS-936558) vs. Everolimus in Subjects With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy
Brief Summary: The purpose of the study is to compare the clinical benefit, as measured by duration of overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy


Options:
A: Inclusion Criteria:

* Diagnosis histologically confirmed of renal cells carcinoma (every histotype);
* Age \< 75 years
* Radical surgical removal of the tumor: total or partial nephrectomy within previous 3 months
* Patient classified as T1 (with diameter \> 2,5 cm), T2, T3 a-b-c; In presence of involvement of loco-regional lymph-nodes (staging N1, N2, N3, TNM class.), metastases should have been completely removed during nephrectomy
* Absence of distant metastases;
* Written informed consent

Exclusion Criteria:

* Tumor diameter equal or less than 2,5 cm;
* Previous chemotherapy or ormonotherapy o immunotherapy;
* Renal insufficiency \>3 mg/dl);
* No symptomatic arrhythmias or autoimmune disease
B: Inclusion Criteria:

Male and female subjects ≥18 years of age with newly diagnosed advanced stage RCC will be eligible for inclusion in this study if all of the following criteria apply:

1. Newly diagnosed advanced stage RCC.
2. Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible for excisional biopsy/metastasectomy.
3. Measurable disease.
4. Candidate for sunitinib treatment as labeled.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Memorial Sloan Kettering Cancer Center (MSKCC) risk group 0 or 1.
7. No brain metastases detected by MRI.
8. Normal renal function in the contralateral kidney.
9. Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
10. Use of appropriate birth control methods for the duration of the study for women of childbearing potential and men with female partners of childbearing potential.
11. Clinically acceptable Screening results according to the following specific limits:

    * Adequate hematologic function.
    * Adequate renal and hepatic function.
    * Adequate coagulation function.
12. Normal serum calcium.
13. Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
14. Voluntary informed consent given to participate in the study.

Exclusion Criteria:

Subjects will NOT be eligible for inclusion in this study if any of the following criteria apply:

1. Nephrectomy for RCC therapy is required.
2. Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment.
3. Uncontrolled hypertension.
4. Type I diabetes mellitus (insulin therapy for Type II diabetes IS permitted).
5. Prior systemic therapy for advanced stage RCC.
6. Active autoimmune disease.
7. Prior history of malignancy other than RCC within the preceding 5 years, except for adequately treated cervical cancer or non-melanoma skin cancer.
8. Use of prohibited prescription or prohibited non-prescription drugs during 2 months prior to entry into the study.
9. Active, acute, or chronic clinically significant infections.
10. Use of another investigational drug or participation in any investigational drug study within the 28 days prior to the start of study enrollment.
11. Planned or elective anti-cancer surgical treatment other than nephrectomy/excisional biopsy/metastasectomy.
12. History of hypercalcemia, symptomatic hypercalcemia, or hypercalcemia requiring management.
13. Known hypersensitivity to dimethyl sulfoxide (DMSO).
14. Body weight less than 30 kg.
15. Pregnancy or lactation.
C: 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
D: Inclusion Criteria:

* Men \& women ≥18 years of age
* Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component
* Advanced/metastatic RCC
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic setting
* No more than 3 total prior systemic treatment regimens in the advanced or metastatic setting, and evidence of progression on or after last treatment regimen received and within 6 months of enrollment
* Karnofsky Performance Score ≥70%

Exclusion Criteria:

* Any Central Nervous System (CNS) metastases or history of CNS metastases
* Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor
* Any active known or suspected autoimmune disease
* Uncontrolled adrenal insufficiency
* Active chronic liver disease
* Prior malignancy active within past 3 years, except for locally curable cancers

Other protocol-defined inclusion/exclusion criteria apply

Answer: D