A Study to Evaluate MEDI5752 and Axitinib in Subjects with Advanced Renal Cell Carcinoma

Exclusion Criteria

• - Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
• - Concurrent enrollment in another clinical study, unless it is an observational study.
• -Previous treatment with mTOR inhibitors, PD-1, PD-L1, or CTLA-4 inhibitors for RCC or any other immune checkpoint inhibitor
• - Previous treatment with VEGF inhibitors
• - Evidence of the following infections: active infection including tuberculosis, human immunodeficiency virus, chronic or active hepatitis B or chronic or active hepatitis C
• - History of organ transplant
• - Active or prior documented autoimmune or inflammatory disorders
• - Current or prior use of immunosuppressive medication within 14 days prior to the first
• dose of investigational product.
• - Poorly controlled blood pressure (BP) defined as systolic BP ≥ 140/90 mmHg at screening and not able to be controlled prior to Cycle 1 Day 1 and any change in antihypertensive medications within 1 week prior to Cycle 1 Day 1.
• - Thromboembolic (arterial or venous) events within previous 6 months
• - Any concurrent therapy for cancer
• - Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product
• - Known allergy or hypersensitivity to investigational product(s) or any of the excipients of
• the investigational product(s)
• - Untreated or progressive CNS metastatic disease, any leptomeningeal disease, or cord compression
• - History of another primary malignancy
• - Unresolved toxicities from previous anticancer therapy
• - Major surgery within 4 weeks prior to enrollment or radiation therapy within 2 weeks prior to enrollment or has not recovered from AEs due to prior treatment
• - Female subjects must not breastfeed and must not donate, or retrieve for their own use, ova from screening to 3 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.
• - History of arrhythmia which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia
• - Uncontrolled intercurrent illness within the last 6 months prior to enrollment
• - Clinically significant gastrointestinal abnormality
• - Serious nonhealing wound, ulcer, or bone fracture
• - Has clinically significant hemoptysis (at least 0.5 teaspoon of bright red blood) or tumor bleeding within 2 weeks before the first dose of investigational product
• - Radiographic evidence of major blood vessel invasion/infiltration/encasement