Phase I study of pre-operative combination therapy with Mogamulizumab (anti-CCR4) and Nivolumab (anti-PD-1) 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

Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University0 sites16 target enrollmentMarch 15, 2016

ConditionsGastric cancer, esophageal cancer, lung cancer, renal cancer and oral cancer patients who are scheduled to have the first standard operation

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Gastric cancer, esophageal cancer, lung cancer, renal cancer and oral cancer patients who are scheduled to have the first standard operation
Sponsor: Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University
Enrollment: 16
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 15, 2016

End Date

April 30, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University

Eligibility Criteria

Inclusion Criteria

Not provided

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