UMIN-CTR Clinical Trial

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

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

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Department of Medicine, Aichi Medical University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

ONO PHARMACEUTICAL CO., LTD., Kyowa Hakko Kirin Co., Ltd.

Organization

-

Address

577, Matsushima, Kurashiki City, Okayama 701-0192, Japan

Tel

-

Email

-

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

03

Month

15

Day

Last modified on

2021

Year

04

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024753