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

  • STATUS
    Recruiting
  • End date
    Jun 16, 2023
  • participants needed
    77
  • sponsor
    MedImmune LLC
Updated on 19 February 2021

Summary

The purpose of this study is to evaluate MEDI5752 in combination with axitinib.in subjects with advanced renal cell carcinoma.

Description

The purpose of this Phase 1b study is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of MEDI5752 in combination with axitinib in subjects with advanced renal cell carcinoma.

Details
Condition Advanced Renal Cell Carcinoma
Treatment Axitinib, MEDI5752
Clinical Study IdentifierNCT04522323
SponsorMedImmune LLC
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 101 yrs?
Gender: Male or Female
Do you have Advanced Renal Cell Carcinoma?
Do you have any of these conditions: Do you have Advanced Renal Cell Carcinoma??
Do you have any of these conditions: Do you have Advanced Renal Cell Carcinoma??
Do you have any of these conditions: Do you have Advanced Renal Cell Carcinoma??
Do you have any of these conditions: Do you have Advanced Renal Cell Carcinoma??
Do you have any of these conditions: Do you have Advanced Renal Cell Carcinoma??
Do you have any of these conditions: Do you have Advanced Renal Cell Carcinoma??
History of arrhythmia which is symptomatic or requires treatment symptomatic or uncontrolled atrial fibrillation despite treatment
Uncontrolled intercurrent illness within the last 6 months prior to enrollment
Clinically significant gastrointestinal abnormality
Evidence of inadequate wound healing
Current use or anticipated need for treatment with drugs or foods that are known strong CYP3A4/5 inhibitors

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 inhibitors
Previous treatment with axitinib; other VEGF TKIs used in the adjuvant setting are allowed if last dose > 6 months prior to the first dose of investigational product
History of active primary immunodeficiency
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
Has poorly controlled hypertension defined as systolic BP 140 mm Hg and/or diastolic BP 90 mm Hg
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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