Clinical trial NCT02946671: Study of Pre-operative Combination Therapy With Mogamulizumab and Nivolumab Against Solid Cancer Patients
Official title: Phase I Study of Pre-operative Combination Therapy With Mogamulizumab (Anti-CCR4) and Nivolumab (Anti-PD-1) Against Solid Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Cancer
Esophageal Cancer
Lung Cancer
Renal Cancer
Oral Cancer
Lead sponsor: Osaka University
Sponsor class: OTHER
Collaborators: name: Kyowa Kirin Co., Ltd.
name: Ono Pharmaceutical Co. Ltd
name: Clinical Study Support, Inc.
name: Fiverings Co., Ltd.
First posted: 2016-10-27
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with adverse events including intraoperative and postoperative complications
timeFrame: from first administration to 60 days after the final administration or to 30 days after the standard operation
measure: Rate of Foxp3-positive patients in tumor by immunohistochemical analysis
timeFrame: from baseline until standard operation, an average of 7 weeks
Secondary outcomes:
measure: Objective tumor response rate according to RECIST v1.1
timeFrame: from baseline to 6 weeks after the first administration
measure: Rate of Treg decrease in peripheral blood mononuclear cell (PBMC)
timeFrame: from baseline to 60 days after the final administration or to 30 days after the standard operation
Other outcomes:
Locations:
city: Suita
country: Japan
facility: Osaka University
state: Osaka
Study officials:
affiliation: Department of Clinical Research in Tumor Immunology, Graduate School of Medicine, Osaka University
name: Hisashi Wada, M.D., Ph.D
role: STUDY_CHAIR
References: