A Study Of Avelumab In Combination With Axitinib In Advanced Renal Cell Cancer (JAVELIN Renal 100)

Inclusion Criteria:

- Histologically or cytologically confirmed advanced RCC with clear cell component

- Primary tumor resected

- Availability of a recent formalin-fixed, paraffin-embedded (FFPE) tumor tissue block
from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a
RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue
block (not cut slides) from a primary or metastatic tumor resection or biopsy can be
provided if the following criteria are met: 1) the biopsy or resection was performed
within 1 year of enrollment AND 2) the patient has not received any intervening
systemic anti-cancer treatment from the time the tissue was obtained and enrollment
onto the current study. If an FFPE tissue block cannot be provided as per documented
regulations,, 15 unstained slides (10 minimum) will be acceptable.

- Availability of an archival FFPE tumor tissue block from primary diagnosis specimen
(if available and not provided per above). If an FFPE tissue block cannot be provided,
15 unstained slides (10 minimum) will be acceptable

- At least one measureable lesion as defined by RECIST version 1.1 that has not been
previously irradiated.

- Age ≥18 years (≥ 20 years in Japan).

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate bone marrow function, renal and liver functions

Exclusion Criteria:

- Prior systemic therapy directed at advanced RCC.

- Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has
occurred during or within 12 months after the last dose of treatment

- Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti
CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody
(including ipilimumab), or any other antibody or drug specifically targeting T cell co
stimulation or immune checkpoint pathways

- Prior therapy with axitinib as well as any prior therapies with other VEGF pathway
inhibitors.

- Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any
history of anaphylaxis.

- Any of the following in the previous 6 months: myocardial infarction, severe/unstable
angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
cerebrovascular accident, transient ischemic attack, deep vein thrombosis or
symptomatic pulmonary embolism.

- Vaccination within 4 weeks of the first dose of avelumab and while on trial is
prohibited except for administration of inactivated vaccines (for example, inactivated
influenza vaccines).