ABOUT THIS STUDY
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.
Renal tumors of low risk or M1
- Non-clear cell histology at biopsy
- Clinically significant gastrointestinal abnormalities that may affect absorption of
- 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
- 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
- Known severe hypersensitivity reactions to monoclonal antibodies
- Pregnancy or lactation
- Known alcohol or drug abuse
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