Study Testing the Biologic Activity and Safety of a Immunotherapeutic in Patients With Newly Diagnosed Advanced Stage Kidney Cancer in Combination With a Marketed Renal Cell Carcinoma Treatment

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

Study to investigate an anticancer cellular immunotherapeutic, AGS-003, when used in combination with sunitinib in subjects with previously untreated advanced stage RCC.

The purpose of this study is to investigate an anticancer immunotherapeutic, AGS-003, when used in combination with sunitinib (the treatment regimen) in a single-stage, Phase II design in subjects with previously untreated advanced stage RCC after nephrectomy/excisional biopsy/metastasectomy. AGS-003 is formulated using mature DCs co-electroporated with CD40L IVT RNA and autologous total tumor RNA

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.