An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.
This study will investigate the combination of an autologous ribonucleic acid (RNA) electroporated dendritic cell (DC) based immunotherapy, AGS-003, plus standard treatment (initiating with sunitinib). The primary objective in this study is to determine the median OS achieved by this combination compared to the OS resulting from use of active control (standard treatment), in a population of adults with advanced renal cell carcinoma (RCC), with nephrectomy indicated, and with remaining metastatic disease.
Key Inclusion Criteria for Tumor Collection:
Key Exclusion Criteria for Tumor Collection:
Key Inclusion Criteria for Treatment Study:
Key Exclusion Criteria for Treatment Study:
Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy
Prior history of malignancy within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer, adequately treated early stage breast cancer, superficial bladder cancer, and non-metastatic prostate cancer with a normal PSA
History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
Patients with 4 or more of the following risk factors:
Planned or elective surgical treatment post-nephrectomy for the direct management of RCC, within 28 days before Visit 1 (Week 0)
NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0)
Clinically significant cardiovascular conditions within 3 months prior to Randomization
Significant gastrointestinal abnormalities
Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
Active autoimmune disease or condition requiring chronic immunosuppressive therapy
Clinically significant infections, including human immunodeficiency virus, syphilis, and active hepatitis B or C
Current treatment with an investigational therapy on another clinical trial
Pregnancy or breastfeeding
Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment