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Study of Combination Therapy for Renal Cell Carcinoma
To provide combination therapies as a first line treatment for patients with locally advanced or metastatic renal cell carcinoma and to collect additional data on treatment safety.
In order to participate you must meet the following criteria:
- Have histologically confirmed diagnosis of renal cell carcinoma with clear cell component with or without sarcomatoid features.
- Have locally advanced/metastatic disease (i.e., Stage IV renal cell carcinoma per American Joint Committee on Cancer) or have recurrent disease.
- Have measurable disease per RECIST 1.1 as assessed by the investigator /site radiologist. Target lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Have received no prior systemic therapy for advanced renal cell carcinoma.
You will be excluded from the study if any of the following criteria apply to you:
- Have had major surgery within 4 weeks prior to randomization or radiation therapy within 2 weeks prior to randomization, or who has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment.
- Have had prior treatment with any anti-PD-1, or PD-L1, or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms. Examples of such antibodies include (but are not limited to) antibodies against IDO, PD -L1, IL-2R, and GITR.
- Have received prior therapy with VEGF/VEGFR or mTOR targeting agents. Note: Prior neoadjuvant/adjuvant therapy of these targeted agents is acceptable if completed > 12 months prior to randomization.
- Have a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to axitinib or sunitinib.
This is a partial list of inclusion and exclusion criteria.