Advanced Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Renal Cell Carcinoma
Conditions
Keywords
RCC, Kidney Cancer
Brief 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.
Detailed description
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.
Interventions
DRUGStandard Treatment
Standard treatment for Renal Cell Carcinoma
BIOLOGICALAGS-003
Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
Sponsors
Argos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | From date of subject randomization to date of death; assessed up to 42 months or until 290 deaths have been accrued on study | Duration from randomization to death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | From date of subject randomization to date of progression; assessed up to 42 months | — |
| Tumor Response | From date of subject randomization to date of progression; assessed up to 42 months | Monitor for evidence of the following tumor responses: Objective response rate, Duration of overall response, and Disease control rate. |
| Monitor treatment emergent adverse events between both arms | From safety baseline until either meeting a discontinuation criterion or death; assessed up to 42 months | Compare adverse events between both arms. |
Countries
Canada, Czechia, Hungary, Israel, Italy, Spain, United Kingdom, United States
Outcome results
None listed