Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase II Study Testing the Safety and Activity of AGS-003 as an Immunotherapeutic in Subjects With Newly Diagnosed Advanced Stage Renal Cell Carcinoma in Combination With Sunitinib
Brief Summary: Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.


Options:
A: Inclusion Criteria:

* Subjects must have a histologically confirmed metastatic RCC with a clear cell component
* Low or intermediate risk according to the Memorial Sloan Kettering Cancer Center (MSKCC) prognostic risk classification.
* Measurable disease with at least one unidimensionally measurable lesion per RECIST guidelines with modifications
* Adequate organ and hematological function as evidenced by laboratory studies conducted at Screening.
* ECOG of 0 or 1

Exclusion Criteria:

Disease Related

* Known history of central nervous system metastases.
* Previous treatment (excluding surgery and palliative radiotherapy) for advanced or metastatic renal cell carcinoma
* Focal radiation therapy for palliation of pain from bony metastases within 14 days of randomization.

Medications

* Currently or previously treated with inhibitors of VEGF.
* Currently or previously treated with inhibitors of angiopoietin or Tie2.
* Currently or previously treated with bevacizumab.

General Medical

* Diagnosis of acute pancreatitis.
* Myocardial infarction, cerebrovascular accident, transient ischemic attack, percutaneous transluminal coronary angioplasty/stent, congestive heart failure, grade 2 or greater peripheral vascular disease, arrhythmias not controlled by outpatient medication, or unstable angina within 1 year prior to randomization
* Major surgery within 30 days before randomization or still recovering from prior surgery
* Uncontrolled hypertension as defined as diastolic \> 90 mmHg OR systolic \>150 mmHg. Anti-hypertensive medications are permitted.

Other

* Other investigational procedures are excluded
* Subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
B: 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
C: 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.
D: 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

Answer: C