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To determine the feasibility and safety of avelumab and gemcitabine combination therapy in patients with metastatic sRCC.
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Inclusion criteria
Patients must have ≤3 prior systemic treatment regimens with recent evidence of disease progression by RECIST 1.1 criteria. Previous treatment with immune-checkpoint inhibitor therapy is allowable as a line of systemic therapy for the phase I portion. Prior systemic therapy in the adjuvant treatment setting is allowable as a prior line of therapy.
Phase Ib dose-expansion portion only:
Patients must have been treated with 0 or 1 prior lines of systemic therapy. Previous treatment with immune-checkpoint inhibitor therapy is allowable as a line of systemic therapy for the phase Ib expansion portion.
Outside pathology report is sufficient for study eligibility. However, pathology should still be obtained as possible for internal institutional pathology review.
Hematologic: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and hemoglobin ≥ 9 g/dL (may have been transfused) Hepatic: Total bilirubin level ≤ 1.5 × the upper limit of normal (ULN) range and AST and ALT levels ≤ 2.5 × ULN or AST and ALT levels ≤ 5 x ULN (for subjects with documented metastatic disease to the liver).
Renal: Estimated creatinine clearance ≥ 45 mL/min using Cockroft Gault formula.
Pregnancy test: Negative serum or urine pregnancy test at screening for women of childbearing potential.
Contraception: Highly effective contraception for both male and female subjects throughout the study and for at least 30 days after last avelumab treatment administration if the risk of conception exists.
In addition, women must not breastfeed while on this study as study drugs may also affect a breast-feeding child. Pregnant women and women who are breastfeeding are not allowed to participate in this study.
Exclusion criteria
Primary purpose
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Interventional model
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6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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