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Renal Cell Carcinoma

AGS-003 for Advanced Renal Cell Carcinoma
An International Phase 3 Randomized Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (ADAPT)
Status Conditions Phase Study ID
Recruiting Renal Cell Carcinoma Phase III NCT01582672
Summary

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.


Investigator
Scott S. Tykodi, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)

Key Inclusion Criteria for Tumor Collection:

  1. Diagnosis or clinical signs of advanced RCC as defined by TNM classification of [any T, any N, M1].
  2. Scheduled for unilateral or partial nephrectomy

Key Exclusion Criteria for Tumor Collection:

  1. RCC that does not meet TNM classification of [any T, any N, M1].
  2. Known inability to undergo sunitinib treatment as currently labeled, due to pre-existing medical conditions
  3. Requirement for systemic chronic immunosuppressive drugs or corticosteroids
  4. Brain metastases detected by MRI or computerized cranial tomography, if central nervous system scans are available
  5. Four or more of the following preoperative risk factors:

    1. Albumin < LLN
    2. LDH > ULN
    3. Symptoms at presentation due to metastases (i.e., bone pain, neurologic symptoms)
    4. Retroperitoneal adenopathy
    5. Supradiaphragmatic adenopathy
    6. Clinical stage T3 or T4
    7. Liver metastases

Key Inclusion Criteria for Treatment Study:

  1. Advanced disease, histologically assessed as RCC, with a component of clear cell histology
  2. Measurable metastatic disease that can be monitored throughout the course of the study participation per RECIST 1.1 (refer to Appendix C)
  3. Subjects who are candidates for a first-line therapy initiating with sunitinib
  4. Time from diagnosis to treatment < 1 year
  5. Karnofsky performance status (KPS) ≥ 80%
  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 other than RCC within the preceding 3 years, except for adequately treated in situ carcinomas or non-melanoma skin cancer
  3. History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease
  4. Patients with 5 or more of the following risk factors:
    1. Time from diagnosis to treatment <1 year
    2. Hgb < LLN
    3. Corrected calcium > 10.0 mg/dL
    4. KPS < 80%
    5. Neutrophils > ULN
    6. Platelets > ULN
  5. Planned or elective surgical treatment or radiation therapy post-nephrectomy within 28 days before Visit 1 (Day 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
Last Updated
August 23, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.