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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

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

The purpose of this study is to evaluate MEDI5752 in combination with Lenvatinib (or
Axitinib), in subjects with advanced renal cell carcinoma.
Kidney (Renal Cell), Phase I
Phase I
Mol. targeted/Immunotherapy/Biologics
Lenvatinib, MEDI5752
Rini, Brian
Vanderbilt University


18 Years
Inclusion Criteria:

Age 18 at the time of screening

Body weight > 35 kg

Written informed consent

Histologically or cytologically proven advanced RCC with clear cell component

Advanced RCC not previously treated in that setting

Provision of tumor material ( 5 unstained slides or tissue block) from an archival or fresh tissue sample

ECOG performance status of 0 or 1

Subjects must have at least 1 measurable lesion according to RECIST v1.1

Life expectancy 12 weeks

Adequate organ and marrow function

Female subjects of childbearing potential must have negative pregnancy test at screening and prior to each administration of investigational product, and must use at least one highly effective method of contraception.

Strongly recommend nonsterilized male partners of female subjects of childbearing potential use a male condom plus spermicide from screening to 7.6 months after the last dose of MEDI5752 and 30 days after the last dose of lenvatinib.

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

To learn more about any of our clinical
trials, call 615-936-8422.