Phase 3 Trial of Autologous Dendritic Cell Immunotherapy (AGS-003) Plus Standard Treatment of Advanced Renal Cell Carcinoma (RCC)
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: III What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 13-000333
NCT ID: NCT01582672
Sponsor Protocol Number: AGS-003-007
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility criteria
Key Inclusion Criteria for Tumor Collection:
- Diagnosis or clinical signs of advanced RCC
- Scheduled for cytoreductive or partial nephrectomy
Key Exclusion Criteria for Tumor Collection:
- Known inability to undergo sunitinib treatment as currently labeled, due to pre-existing medical conditions
- Requirement for systemic chronic immunosuppressive drugs or corticosteroids
- Evidence of brain metastases prior to nephrectomy
Key Inclusion Criteria for Treatment Study:
- Advanced disease, histologically assessed as RCC, with predominantly clear cell histology
- Metastatic disease (measurable or non-measurable) that can be monitored throughout the course of the study participation per RECIST 1.1
- Subjects who are candidates for standard first-line therapy initiating with sunitinib
- Time from diagnosis to treatment < 1 year
- Karnofsky performance status (KPS) ≥ 70%
- Life expectancy of 6 months or greater
- 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
- Adequate hematologic, renal, hepatic, and coagulation function
- 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
- Normal ECG or clinically non-significant finding(s) at Screening
- Able to abstain from taking prohibited drugs, either prescription or non-prescription, during the treatment phase of the study
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
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:
- Hgb < LLN
- Corrected calcium > 10.0 mg/dL
- KPS < 80%
- Neutrophils > ULN
- Platelets > ULN
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.