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Single Arm Phase Ib/II Study of Durvalumab and Guadecitabine in Advanced Kidney Cancer: Big Ten Cancer Research Consortium(BTCRC-GU16-043) (PSCI 18-008)

This study is being done to test the safety of combining durvalumab with guadecitabine. It will also measure the percentage of patients whose tumor shrank after receiving durvalumab in combination with guadecitabine. Participants with kidney cancer that has spread to other parts of the body, also known as 'metastatic kidney cancer' will be recruited to participate.
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03308396
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Inclusion Criteria:
Histological diagnosis of clear cell renal cell carcinoma (pure or mixed) with radiologic or histologic evidence of metastatic disease
Prior cancer treatment must be completed at least 14 dats prior to study registration and the subject must have recovered from all reversible acute toxic effects of the regimen (other than alopecia) to Grade 1 or less baseline
ECOG Performance Status 0-1 within 28 days prior to registration
Demonstrate adequate organ function based on necessary screening labs to be obtained within 28 days prior to registration
Females of childbearing potential must have a negative serum pregnancy test within 28 days prior to registration
Exclusion Criteria:
Active infection requiring systemic therapy
Brain metastases or spinal cord compression
Pregnant or breastfeeding
Treatment with any investigational drug within 14 days prior to study registration
Current or prior use of immunosuppresive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiologic doses
Kidney & Urinary System, Cancer
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Study Locations

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Location
Hershey, PA