Gastric Cancer, Esophageal Cancer, Lung Cancer, Renal Cancer, Oral Cancer
Conditions
Brief summary
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.
Interventions
BIOLOGICALMogamulizumab
Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
BIOLOGICALNivolumab
Nivolumab (3.0 mg/kg) is administered.
Sponsors
Kyowa Kirin Co., Ltd.
Ono Pharmaceutical Co. Ltd
Clinical Study Support, Inc.
Fiverings Co., Ltd.
Osaka University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with adverse events including intraoperative and postoperative complications | from first administration to 60 days after the final administration or to 30 days after the standard operation | Confirm the toxicity profile, which is measured by the degree of grade and seriousness, duration, causality, classification, etc. of the adverse events. |
| Rate of Foxp3-positive patients in tumor by immunohistochemical analysis | from baseline until standard operation, an average of 7 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective tumor response rate according to RECIST v1.1 | from baseline to 6 weeks after the first administration |
| Rate of Treg decrease in peripheral blood mononuclear cell (PBMC) | from baseline to 60 days after the final administration or to 30 days after the standard operation |
Countries
Japan
Outcome results
None listed