This phase I trial is evaluating the combination of two targeted cancer drugs in patients with advanced renal cell carcinomaA Phase 1b, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI5752 in Combination With Axitinib in Subjects With Advanced Renal Cell Carcinoma

Exclusion

• 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