Neoadjuvant AXITINIB and AVELUMAB for Patients With Localized Clear-cell RCC

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 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.
* Highly effective contraception for both male and female subjects if the risk of conception exists.

Exclusion Criteria:

Renal tumors of low risk or M1

* Non-clear cell histology at biopsy
* Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product
* Corrected QT interval (QTc) \> 480 msecs
* History of any of the cardiovascular conditions defined in the protocol within the past 6 months
* Poorly controlled hypertension
* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* 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
* Evidence of active bleeding or bleeding diathesis.
* Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
* Unable or unwilling to discontinue use of prohibited medications to be listed in protocol for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
* Treatment with any of the following anti-cancer therapies: chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of axitinib or avelumab
* Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment
* Prior organ transplantation, including allogeneic stem cell transplantation
* Significant acute or chronic infections as defined in protocol
* Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent
* Known severe hypersensitivity reactions to monoclonal antibodies
* Pregnancy or lactation
* Known alcohol or drug abuse