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Therapeutic Areas: Oncology | Nephrology/Urology
Disease Category: Renal Cell Carcinoma

Trial Information

A Phase II Study Testing the Safety and Activity of AGS-003 as an Immunotherapeautic in Subjects with Newly Diagnosed Advanced Stage Renal Cell Carcinoma in Combination with Sunitinib

Purpose of Study
The purpose of this study is to determine the effect that AGS-003 has on your type of cancer when given in combination with sunitinib.

Kidney cell cancer that has not spread is potentially curable by surgery. After the disease has spread it is often resistant to standard treatment of chemotherapy, irradiation and hormonal treatment. Therefore, an effective therapy needs to be created.

AGS-003 is an investigational drug which means that it is not approved by the Untied States Food and Drug Administration (FDA) for the treatment of advance kidney cell cancer. The drug works by combining with white blood cells from your body with your tumor in a lab. It is thought that these white blood cells can then learn to fight the cancer cells. When the cells are injected back into your body, they can train other cells to find and kill cancer cells.

Sunitinib (Sutent) has been approved by the United States Food and Drug Administration for the treatment of advance Renal Cell Carcinoma.

For more information on this study, click here.

Inclusion Criteria

• Male and female subjects 18 years of age or older with newly diagnosed advanced stage Renal Cell Carcinoma/kidney cancer;
• Candidate for sunitinib treatment as labeled.
• Normal renal function in the contralateral kidney (kidney without tumor)
• 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 with the exception of post-menopausal women and study participants who are surgically sterile.
• Ability to communicate effectively with study personnel
• 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:

• Any serious medical condition such as cardiopulmonary disease, circulatory compromise, hepatic or renal dysfunction, or other 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 including HIV and viral hepatitis.
• Use of another investigational drug or participation in any investigational drug study within the 28 days prior to the start of study enrollment.

Melissa Morrison
Blumenthal Cancer Center
1025 Morehead Medical Drive, 6th Floor
Charlotte, NC 28204
Phone: (704) 355-7024

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