UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050515 |
|---|---|
| Receipt number | R000057164 |
| Scientific Title | NIVOlumab Re-adminisTration for UnResectable/recurreNt gaStric cancer |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/04/28 15:53:38 |
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Basic information
Public title
NIVOlumab Re-adminisTration for UnResectable/recurreNt gaStric cancer
Acronym
NIVO-RETURNS
Scientific Title
NIVOlumab Re-adminisTration for UnResectable/recurreNt gaStric cancer
Scientific Title:Acronym
NIVO-RETURNS
Region
| Japan |
Condition
Condition
Unresectable advanced or recurrent gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of re-administration of nivolumab in patients previously treated with anti-PD-1/anti-PD-L1 antibodies
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Response rate
Key secondary outcomes
1)Overall Survival (OS) after re-administration of nivolumab
2)Disease control rate (DCR) of nivolumab re-administration
3)Progression Free Survival (PFS) after nivolumab re-administration
4) Time to Treatment Failure (TTF) after nivolumab re-administration
5) RR, DCR, OS, PFS, and TTF by the following subgroups
a. Combined positive score (CPS) score (CPS<1, 1<=CPS<5, 5<=CPS)
b. Best response to prior therapy including anti-PD-1/PD-L1 antibody
c. History of treatment with FTD/TPI or irinotecan
d. HER2 status
6) irAE in nivolumab re-administration (CTCAE v5.0)
7) Other efficacy analysis by patient background
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Unresectable or recurrent gastric cancer with histologically confirmed gastric adenocarcinoma. Esophagogastric junction carcinoma with the center of the tumor within 2 cm from the esophagogastric junction is also acceptable.
2) ECOG performance status (PS): 0-2
3) Age: 18 years or older
4) Confirmed disease progression after achieved CR/PR or SD lasting at least 6 months to prior therapy including anti-PD-1/PD-L1 antibody therapy.(see a.-e. below)
a.Any type of anti-PD-1/PD-L1 antibody.
b. Any treatment regimen or line except neoadjuvant or adjuvant therapy.
Patients who were treated for the purpose of conversion surgery and who have evaluable lesion can be enrolled.
c. Cases in which anti-PD-1/PD-L1 antibody were concomitantly administered during the course of the same treatment regimen or line, or were discontinued during the course of the regimen for reasons other than intolerance can be enrolled.
d. Patients treated with anti-PD-1/PD-L1 antibody as monotherapy can be enrolled.
e. Patients who were treated with following therapy before confirming disease progression are not eligible for registration.
5) Patients who were treated at least one regimen of any anti-cancer therapy after the prior therapy including anti-PD-1/PD-L1 antibodies.
6) Patients who are treated ICI re-administration for the first time.
7) Patients with measurable lesions by RECIST (ver. 1.1)
8) Patients who have been fully informed about the study and have given their written consent.
Key exclusion criteria
1) Patients with multiple cancers requiring systemic therapy excluding hormonal therapy.
2) Patients who are inappropriate for re-administration of nivolumab by the treating physician due to serious irAEs in previous therapy including anti-PD-1/PD-L1 antibodies.
Patients with endocrine abnormalities and who can be re-administered nivolmab with hormone replacement can be enrolled.
3) Patients receiving continuous systemic administration of steroids or immunosuppressive agents with a prednisone equivalent of more than 10 mg/day (or equivalent dose)
4) Patients who are inappropriate for enrollment in this study by the treating physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Muro |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1Kanokoden,Chikusa-ku,Nagoyashi,Aichi Japan
TEL
052-762-6111
kmuro@aichi-cc.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kodama |
Organization
Aichi Cancer Center
Division name
Department of Clinical Oncology
Zip code
464-8681
Address
1-1Kanokoden,Chikusa-ku,Nagoyashi,Aichi Japan
TEL
052-762-6111
Homepage URL
https://cancer-c.pref.aichi.jp/
h.kodama@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi cancer center,Institutional Review Board
Address
1-1 Kanokoden, Chikusa-ku, Nagoya-shi, Aichi Japan
Tel
052-762-6111
irb-jimu@aichi-cc.jp
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
愛知県がんセンター（愛知県）、市立札幌病院（北海道）、独立行政法人国立病院機構 名古屋医療センター（愛知県）、近畿大学病院（大阪府）、独立行政法人国立病院機構 四国がんセンター（愛媛県）、東北大学医学部附属病院（宮城県）、宮崎大学医学部附属病院（宮崎県）、富山大学附属病院（富山県）、NTT東日本関東病院（東京都）、手稲渓仁会病院（北海道）、県立広島病院（広島県）、社会医療法人財団慈泉会 相澤病院（長野県）、聖マリアンナ医科大学病院（神奈川県）、川崎医科大学附属病院（岡山県）、北海道大学病院（北海道）、大崎市民病院（宮城県）、神戸市立医療センター中央市民病院（兵庫県）、JCHO九州病院（福岡県）、九州大学病院（福岡県）、大阪医科薬科大学病院（大阪府）、名古屋市立大学病院（愛知県）、熊本大学病院（熊本県）、神奈川県立病院機構 神奈川県立がんセンター（神奈川県）、大分大学医学部附属病院（大分県）、藤田医科大学病院（愛知県）、国立研究開発法人 国立がん研究センター中央病院（東京都）、兵庫医科大学病院（兵庫県）、東京女子医科大学病院（東京都）、日本赤十字社長崎原爆病院（長崎県）、国家公務員共済組合連合会 斗南病院（北海道）、大阪赤十字病院（大阪府）、岐阜大学医学部附属病院（岐阜県）、独立行政法人国立病院機構 京都医療センター（京都府）、静岡県立総合病院（静岡県）、がん研究会有明病院（東京都）、釧路労災病院（北海道）、九州がんセンター（福岡県）、高知大学医学部附属病院（高知県）、関西医科大学附属病院（大阪府）、慶應義塾大学病院（東京都）、総合病院 土浦協同病院（茨城県）、山形大学医学部附属病院（山形県）、新潟県立がんセンター新潟病院（新潟県）、名古屋大学医学部附属病院（愛知県）、京都府立医科大学病院（京都府）、山梨大学医学部附属病院（山梨県）、千葉県がんセンター（千葉県）、広島市立北部医療センター安佐市民病院（広島県）、横浜市立大学附属病院（神奈川県）、広島市立広島市民病院（広島県）、日本海総合病院（山形県）、トヨタ記念病院（愛知県）、茨城県立中央病院・茨城県地域がんセンター（茨城県）、東邦大学医療センター大森病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although there have been several reports on re-administration of immune checkpoint inhibitors in lung cancer and melanoma, evidence is scant and no data exist in gastric cancer. In this study, we will examine the safety and efficacy of re-administration of nivolumab in unresectable advanced or recurrent gastric cancer previously treated with anti-PD-1/PD-L1 antibodies.
Management information
Registered date
| 2023 | Year | 03 | Month | 07 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057164
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