Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients

Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients

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.

Inclusion Criteria:

• Patients who enable to have standard operation
• Patients who refuse standard preoperative chemotherapy and are diagnosed with following cancers; gastric adenocarcinoma, esophageal squamous cell carcinoma, non-small-cell lung carcinoma, renal cell carcinoma or oral squamous cell carcinoma
• Patients with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
• Patients with no serious disorder of major organs (born marrow, heart, lung, liver and kidney)
• Patients with written informed consent
• Patients who have measurable target lesion
• Patients who are enable to undergo biopsy for sampling tumor tissue

Exclusion Criteria:

• Known or previous autoimmune disease
• Known or suspected interstitial lung disease (ILD)
• Patients with history of serious anaphylaxis induced by antibody preparation
• Uncontrollable hypertension
• Uncontrollable endocrine disease
• Patients who have active inflammatory bowel disease or other serious GI chronic conditions associated with diarrhea
• Uncontrollable diabetes
• Prior therapy with sustained anticancer agents, radiotherapy or surgery for primary disease
• Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study
• Known or suspected infection or inflammatory disease
• Prior therapy with hematopoietic stem cell transplantation
• Known or suspected central nervous system (CNS) involvement