UMIN-CTR Clinical Trial

Basic information
Public title	Phase I study of pre-operative combination therapy with Mogamulizumab (anti-CCR4) and Nivolumab (anti-PD-1) against solid cancer patients
Acronym	Phase I study of pre-operative combination therapy with Mogamulizumab (anti-CCR4) and Nivolumab (anti-PD-1) against solid cancer patients
Scientific Title	Phase I study of pre-operative combination therapy with Mogamulizumab (anti-CCR4) and Nivolumab (anti-PD-1) against solid cancer patients
Scientific Title:Acronym	Phase I study of pre-operative combination therapy with Mogamulizumab (anti-CCR4) and Nivolumab (anti-PD-1) against solid cancer patients
Region	Japan

Condition
Condition	Gastric cancer, esophageal cancer, lung cancer, renal cancer and oral cancer patients who are scheduled to have the first standard operation
Classification by specialty	Gastrointestinal surgery Chest surgery Oto-rhino-laryngology Urology Oral surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	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.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	1) Safety: adverse events, including intraoperative and postoperative complications 2) Immunohistochemical analysis of Foxp3-positive cells in tumor 6 weeks after after initial administration
Key secondary outcomes	1) Response rate 2) Effect to regulatory T cells in peripheral blood

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	<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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Hisashi Middle name Last name Wada
Organization	Graduate School of Medicine, Osaka University
Division name	Department of Clinical Research in Tumor Immunology
Zip code	5650871
Address	2-2 Yamada-oka, Suita city, Osaka
TEL	06-6210-8413
Email	hwada@gesurg.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Tatsushi Middle name Last name Goto
Organization	Secretariat of clinical trial coordinating committee
Division name	(none)
Zip code	5300044
Address	Urban Ace Higashitenma-BLDG, 1-1-19, Higashitenma, Kita-ku, Osaka
TEL	06-6358-7110
Homepage URL
Email	kw0761_jimukyoku@fiverings.co.jp

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

Funding Source
Organization	Department of Medicine, Aichi Medical University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	ONO PHARMACEUTICAL CO., LTD., Kyowa Hakko Kirin Co., Ltd.

IRB Contact (For public release)
Organization	-
Address	577, Matsushima, Kurashiki City, Okayama 701-0192, Japan
Tel	-
Email	-

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	16
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 07 Day
Date of IRB	2016 Year 02 Month 08 Day
Anticipated trial start date	2016 Year 03 Month 17 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 03 Month 15 Day
Last modified on	2021 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024753