Gastric cancer, esophageal cancer, lung cancer, renal cancer and oral cancer patients who are scheduled to have the first standard operation
Conditions
Interventions
<
Cohort 1>
KW-0761 0.1 mg/kg, every week, 4 times ONO-4538 3.0 mg/kg, every two weeks, 3 times <
Cohort 2>
KW-0761 0.3 mg/kg, every week, 4 times ONO-4538 3.0 mg/kg, every two weeks, 3 times <
Cohort 3>
KW-0761 1.0 mg/kg, every week, 4 times ONO-4538 3.0 mg/kg, every two weeks, 3 times
Sponsors
Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who enable to have standard operation 2) 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 3) Patients with ECOG performance status 0 or 1 4) Patients with 20 years old or more 5) Patients with no serious disorder of major organs (born marrow, heart, lung, liver and kidney) 6) Patients with written informed consent 7) Patients who enable to be admitted to hospital on the day of the first administration 8) Patients who have measurable target lesion 9) Patients who are enable to undergo biopsy for sampling tumor tissue
Exclusion criteria
Exclusion criteria: 1) Patients with HIV antibody positive 2) Patients with HCV antibody positive and HCV-RNA positive 3) Patients with HBs antigen or HBV-DNA positive 4) Known or previous antoimmune disease 5) Known or suspected ILD 6) Known or previous tuberculosis 7) Patients with history of serious anaphylaxis induced by antibody preparation 8) Uncontrollable hypertension 9) Uncontrollable endocrine disease 10) Patients who have or plan to have administration of live vaccine or attenuated vaccine within last 4 weeks 11) Patients who have active inflammatory bowel disease or other serious GI chronic conditions associated with diarrhea 12) Uncontrollable diabetes 13) Patients who have unstable angina within last 3 weeks or myocardial infarction within last 6 months 14) Patients with double cancer 15) Sustained administration of adrenal cortical steroids. immune suppressant or immune enhancer within last 4 weeks 16) Prior therapy with sustained anticancer agents, radiotherapy or surgery for primary disease 17) Prior therapy with sustained immunothearapy for cancer within last 12 weeks 18) Pregnant or lactating females, female and male patients who cannot agree to practice the adequate birth control after the consent during the study 19) Known or suspected infection or inflammatory disease 20) Patients with psychosis or dementia to interfere to obtain informed consent appropriately 21) Continuous systemic administration of adrenocorticosteroid 22) Prior therapy with hematopoietic stem cell transplantation 23) Known or suspected CNS involvement 24) Prior therapy with other investigational products within last 4 weeks 25) Any other inadequacy for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety: adverse events, including intraoperative and postoperative complications 2) Immunohistochemical analysis of Foxp3-positive cells in tumor 6 weeks after after initial administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Response rate 2) Effect to regulatory T cells in peripheral blood | — |
Countries
Japan
Contacts
Public ContactTatsushi Goto
Secretariat of clinical trial coordinating committee (none)
Outcome results
None listed