This trial is active, not recruiting.

Conditions advanced renal cell carcinoma, renal cell carcinoma, metastatic renal cell carcinoma
Treatments standard treatment, ags-003
Phase phase 3
Target CD40
Sponsor Argos Therapeutics
Start date November 2012
End date April 2017
Trial size 450 participants
Trial identifier NCT01582672, 2012-000871-17, AGS-003-007


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma. In addition, subjects will receive AGS-003.
Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
(Active Comparator)
Subjects on this arm will receive standard treatment for Renal Cell Carcinoma.
standard treatment Sunitinib
Standard treatment for Renal Cell Carcinoma

Primary Outcomes

Overall Survival
time frame: From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study

Secondary Outcomes

Progression Free Survival
time frame: From date of subject randomization to date of progression; assessed up to 42 months
Tumor Response
time frame: From date of subject randomization to date of progression; assessed up to 42 months
Monitor treatment emergent adverse events between both arms
time frame: From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria for Tumor Collection: 1. Diagnosis or clinical signs of advanced RCC 2. Scheduled for cytoreductive or partial nephrectomy Key Exclusion Criteria for Tumor Collection: 1. Known inability to undergo sunitinib treatment as currently labeled, due to pre-existing medical conditions 2. Requirement for systemic chronic immunosuppressive drugs or corticosteroids 3. Evidence of brain metastases prior to nephrectomy Key Inclusion Criteria for Treatment Study: 1. Advanced disease, histologically assessed as RCC, with predominantly clear cell histology 2. Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of the study participation per RECIST 1.1 3. Subjects who are candidates for standard first-line therapy initiating with sunitinib 4. Time from diagnosis to treatment < 1 year 5. Karnofsky performance status (KPS) ≥ 70% 6. Life expectancy of 6 months or greater 7. Resolution of all acute toxic effects of prior radiotherapy or surgical procedures to Grade ≤ 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 8. Adequate hematologic, renal, hepatic, and coagulation function 9. Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug 10. Normal ECG or clinically non-significant finding(s) at Screening 11. Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures Key Exclusion Criteria for Treatment Study: 1. Prior systemic therapy (including adjuvant or neoadjuvant) of any kind for RCC, including immunotherapy, chemotherapy, hormonal, or investigational therapy 2. 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 3. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease 4. Patients with 4 or more of the following risk factors: 1. Hgb < LLN 2. Corrected calcium > 10.0 mg/dL 3. KPS < 80% 4. Neutrophils > ULN 5. Platelets > ULN 5. Planned or elective surgical treatment post-nephrectomy for the direct management of RCC, within 28 days before Visit 1 (Week 0) 6. NCI CTCAE Grade 3 hemorrhage < 28 days before Visit 1 (Day 0) 7. Clinically significant cardiovascular conditions within 3 months prior to Randomization 8. Significant gastrointestinal abnormalities 9. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication 10. Active autoimmune disease or condition requiring chronic immunosuppressive therapy 11. Clinically significant infections, including human immunodeficiency virus, syphilis, and active hepatitis B or C 12. Current treatment with an investigational therapy on another clinical trial 13. Pregnancy or breastfeeding 14. Any serious medical condition or illness considered by the investigator to constitute an unwarranted high risk for investigational treatment

Additional Information

Official title An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
Principal investigator Robert Figlin, MD, FACP
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Argos Therapeutics.
Location data was received from the National Cancer Institute and was last updated in May 2016.