A Phase 1 interventional study of Mogamulizumab and Nivolumab in Gastric Cancer, Esophageal Cancer and Lung Cancer, sponsored by Osaka University. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2020-03-06.
Sponsored by Osaka University · Phase 1, Interventional, and Treatment
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.
377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.
This study's enrollment of 16 is below the median of 65 across 265 interventional studies indexed under Mouth Neoplasms.
Browse Mouth Neoplasms studies →Osaka University is the lead sponsor of 33 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
KW-0761 (Mogamulizumab): 0.1 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Biological: Mogamulizumab · Biological: Nivolumab
KW-0761 (Mogamulizumab): 0.3 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Biological: Mogamulizumab · Biological: Nivolumab
KW-0761 (Mogamulizumab): 1.0 mg/kg, every week, 4 times ONO-4538 (Nivolumab): 3.0 mg/kg, every two weeks, 3 times
Biological: Mogamulizumab · Biological: Nivolumab
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
Also known as: KW-0761
Nivolumab (3.0 mg/kg) is administered.
Also known as: ONO-4538
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
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Osaka University