kidney cancer renal cell carcinoma
Conditions
Interventions
6 cycles of neoadjuvant axitinib and avelumab followed by nephrectomy
Sponsors
Antoni van Leeuwenhoek Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Signed and written informed consent • Male or female patients age >= 18 years • Histologically confirmed diagnosis of non-metastatic clear-cell renal cell carcinoma of intermediate to high risk with completely resectable primary tumours. • World Health Organization (WHO) performance status of 0-1. • Adequate coagulation function as defined in protocol • Adequate hematological function as defined in protocol • Adequate hepatic function as defined in protocol • Adequate renal function as defined in protocol • Negative serum pregnancy test at screening for women of childbearing potential.
Exclusion criteria
Exclusion criteria: •Renal tumors of low risk or M1 • Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product • Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer • Administration of any non-oncologic investigational drug prior to receiving the first dose of study treatment • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent • Known severe hypersensitivity reactions to monoclonal antibodies • positive test for HBV or HCV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the rate of partial remission following neoadjuvant axitinib and avelumab | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and adverse events of the combination of axitinib with avelumab 2. Clavien Dindo classification of surgical morbidity 3. Long term follow up with DFS, OS, rate of metastasis and local recurrence 4. Translational research | — |
Countries
Netherlands
Outcome results
None listed