UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000034222
Receipt number R000038966
Scientific Title A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer
Date of disclosure of the study information 2018/09/20
Last modified on 2024/03/26 11:37:35

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Basic information

Public title

A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer

Acronym

A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer (Ni-HIGH study)

Scientific Title

A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer

Scientific Title:Acronym

A phase Ib study of Nivolumab plus Trastuzumab with S-1/Capecitabine plus Oxaliplatin for HER2 positive advanced gastric cancer (Ni-HIGH study)

Region

Japan


Condition

Condition

HER2 positive advanced or unresectable gastric cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To investigate the safety and tolerability of a four-drug combination treatment, i.e. newly combined Nivolumab to Trastuzumab with fluoropyrimidine (S-1 /Capecitabine) plus Oxaliplatin, in Part I of the study. In addition, to exploratory evaluate the efficacy of this combination therapy in Part II.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Phase I


Assessment

Primary outcomes

Safety (Adverse events, laboratory findings and vital signs)

Key secondary outcomes

Tolerability


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

Interventions/Control_1

Four-drug combination; Nivolumab, S-1 /Capecitabine, Oxaliplatin and Trastuzumab

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)HER2 positive advanced or unresectable gastric or GEJ cancer that had been confirmed as histological adenocarcinoma.
2)Never been treated by any chemotherapies including for other cancers, chemoradiotherapies, radiation therapies, or hormone therapies.
3)Have at least one evaluable lesion(based on RECIST ver.1.1)
4) Overexpression of HER 2 (IHC 3+, or IHC 2+ and ISH positive [FISH or DISH method]).
5)Age of 20 years and older
6)ECOG Performance Status (PS) is 0 or 1.
7)Functions of main organs (bone marrow, liver, kidney, brain, and blood) are maintained.
8)Have left ventricular ejection rate (LVEF)50% and over measured by echocardiogram or MUGA scan
9)No clinically significant findings in 12-lead electrocardiogram
10)Adequate oral intake.
11)Expected alive more than 3 months.
12)Written informed consent.

Key exclusion criteria

Patients who;
1) have complication or history of severe hypersensitive reactions against any antibody products
2)have any active double cancer with less than 5 years of disease-free interval
3)have any active infection diseases
4)have any of heart diseases or conditions within 6 months before registration;
5)are breastfeeding or not ruled out the potency of pregnancy prior to registration
6)not acknowledge for the birth control minimum 5 months for women and 7months for men after the latest last administration
7)have dyspnea at rest due to lung metastasis or cardiovascular diseases
8)have metastatic lesions in brain or meninges
9)have diarrhea
10)have concomitant of autoimmune diseases, or history of chronic or recurrent autoimmune diseases
11)require the administrations of systemic adrenocortical hormone or immunosuppresses, or had treated by them within 28 days before registration.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Kensei
Middle name
Last name Yamaguchi

Organization

The Cancer Institute Hospital of JFCR

Division name

Gastroenterology Center Gastroenterology medical oncology

Zip code

135-8550

Address

3-8-31 Ariake Koto-ku Tokyo

TEL

03-3520-0111

Email

kensei.yamaguchi@jfcr.or.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Takahari

Organization

The Cancer Institute Hospital of JFCR

Division name

Gastroenterology Center Gastroenterology medical oncology

Zip code

135-8550

Address

3-8-31 Ariake Koto-ku Tokyo

TEL

03-3520-0111

Homepage URL


Email

daisuke.takahari@jfcr.or.jp


Sponsor or person

Institute

The Cancer Institute Hospital of JFCR

Institute

Department

Personal name



Funding Source

Organization

ONO PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A


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

がん研究会有明病院

国立がん研究センター中央病院

埼玉県立がんセンター

千葉県がんセンター


Other administrative information

Date of disclosure of the study information

2018 Year 09 Month 20 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


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

No longer recruiting

Date of protocol fixation

2018 Year 08 Month 23 Day

Date of IRB

2018 Year 09 Month 04 Day

Anticipated trial start date

2018 Year 09 Month 25 Day

Last follow-up date

2026 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 09 Month 20 Day

Last modified on

2024 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038966


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name