Clinical trial NCT02684006 (phase 3, status: active, not recruiting)
Conditions: renal cell cancer
ICD codes: C96.20, C96.29, D47.09
Drugs: avelumab (msb0010718c), axitinib (ag-013736), sunitinib
SMILES: NC1=NC(=O)N(C=N1)[C@H]1C[C@H](O)[C@@H](CO)O1, CNC(=O)C1=C(SC2=CC=C3C(NN=C3\C=C\C3=CC=CC=N3)=C2)C=CC=C1, CNC(=O)C1=C(SC2=CC=C3C(NN=C3\C=C\C3=CC=CC=N3)=C2)C=CC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced or metastatic RCC with clear cell
             component

          -  Availability of a 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 randomization AND 2) the patient has not received any intervening
             systemic anti-cancer treatment from the time the tissue was obtained and randomization
             onto the current study. If an FFPE tissue block cannot be provided as per documented
             regulations then, 15 unstained slides (10 minimum) will be acceptable

          -  Availability of an archival FFPE tumor tissue from primary tumor resection specimen
             (if not provided per above). If an FFPE tissue block cannot be providedas per
             documented regulations 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

          -  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 or metastatic 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 and/or sunitinib as well as any prior therapies with other
             VEGF pathway inhibitors

          -  Newly dignosed or active brain metastasis

          -  Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any
             history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially
             controlled asthma Global Initiative for Asthma 2011)

          -  Any of the following in the previous 12 months: myocardial infarction, severe/unstable
             angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure,
             LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular
             accident, transient ischemic attack

          -  Any of the following in the previous 6 months: 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)