To assess the safety of preoperative combination therapy with KW-0761 (anti-CCR4) and ONO-4538 (anti-PD-1). To assess the behavior of immune cells in peripheral blood and tumor.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
Nivolumab (3.0 mg/kg) is administered.
Osaka University
Suita, Osaka, Japan
Number of patients with adverse events including intraoperative and postoperative complications
Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events.
Time frame: from first administration to 60 days after the final administration or to 30 days after the standard operation
Rate of Foxp3-positive patients in tumor by immunohistochemical analysis
Time frame: from baseline until standard operation, an average of 7 weeks
Objective tumor response rate according to RECIST v1.1
Time frame: from baseline to 6 weeks after the first administration
Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)
Time frame: from baseline to 60 days after the final administration or to 30 days after the standard operation
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