eoadjuvant AXITINIB plus AVELUMAB for patients with localized RCC and a moderate to high risk of recurrence
- Conditions
- kidney cancerrenal cell carcinoma10038364
- Registration Number
- NL-OMON48706
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
• 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.
•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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method