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

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:

• Newly diagnosed advanced stage RCC.
• Eligible for unilateral nephrectomy or partial nephrectomy; OR, Has lesion accessible for excisional biopsy/metastasectomy.
• Measurable disease.
• Candidate for sunitinib treatment as labeled.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Memorial Sloan Kettering Cancer Center (MSKCC) risk group 0 or 1.
• No brain metastases detected by MRI.
• Normal renal function in the contralateral kidney.
• Able to abstain from taking prohibited prescription or prohibited non-prescription drugs.
• 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.
• Clinically acceptable Screening results according to the following specific limits:

• Adequate hematologic function.
• Adequate renal and hepatic function.
• Adequate coagulation function.
• Normal serum calcium.
• Ability to communicate effectively with study personnel; considered reliable, willing, and cooperative in terms of compliance with the Protocol requirements.
• 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:

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