UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046820 |
|---|---|
| Receipt number | R000053423 |
| Scientific Title | A NON-INTERVENTIONAL OBSERVATIONAL STUDY OF EFFECTIVENESS AND SAFETY OF NIVOLUMAB PLUS CHEMOTHERAPY FOR UNTREATED ADVANCED RECURRENT GASTRIC CANCER |
| Date of disclosure of the study information | 2022/02/03 |
| Last modified on | 2023/12/20 14:54:18 |
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Basic information
Public title
A NON-INTERVENTIONAL OBSERVATIONAL STUDY OF EFFECTIVENESS AND SAFETY OF NIVOLUMAB PLUS CHEMOTHERAPY FOR UNTREATED ADVANCED / RECURRENT GASTRIC CANCER
Acronym
G-KNIGHT
Scientific Title
A NON-INTERVENTIONAL OBSERVATIONAL STUDY OF EFFECTIVENESS AND SAFETY OF NIVOLUMAB PLUS CHEMOTHERAPY FOR UNTREATED ADVANCED RECURRENT GASTRIC CANCER
Scientific Title:Acronym
G-KNIGHT
Region
| Japan |
Condition
Condition
ADVANCED/GASTRIC CANCER
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To describe the effectiveness, safety, and actual treatment status in the real-world setting of nivolumab plus chemotherapy as a first-line treatment for untreated advanced/recurrent gastric cancer.
Basic objectives2
Others
Basic objectives -Others
Effectiveness
Safety
Actual Treatment status
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effectiveness
-Progression-free survival (PFS)
-Objective response rate (ORR)
Safety
-Incidence of all immune-related adverse events (irAE) according to CTCAE v5.0
-Incidence of treatment-related adverse events (TRAE) that have led to treatment discontinuation
Key secondary outcomes
Effectiveness
-Overall survival (OS)
-Duration of treatment (DOT)
-Duration of response (DOR)
-DOT of second-line treatment
-PFS, ORR, and DOT of nivolumab treatment in third or later line treatment
-OS, PFS, ORR, and DOT by patient characteristics
Actual treatment status
-Time to next treatment (TNT)
-Rate of patients who have received subsequent therapy
-Treatment status
Safety
-Safety by patient characteristics
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To participate in this study, the following criteria MUST be met at the time of informed consent:
1.Patients aged over 20 years.
2.Patients with histologically confirmed advanced or recurrent gastric cancer.
3.Patients who have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31, 2022. For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable.
Patients who have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study. If it is difficult to obtain consent from the patient, the following points a) through c) are acceptable:
a) Patients who have difficulty writing may be registered in this study by a person equivalent to a legally acceptable representative writing on their behalf, with the patient's oral consent.
b) Patients who have difficulty obtaining consent may be registered in this study if written consent is obtained from the legally acceptable representative after explanation to the legally acceptable representative.
c)If it is difficult to obtain informed consent from the patient or legally acceptable representative for various reasons other than a) and b), registration is allowed by opt-out.
Key exclusion criteria
To participate in this study, the following criteria MUST NOT be met at the time of informed consent:
1.Patients who have been treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (patients who have received prior perioperative chemotherapy and patients who have received prior bisphosphonates for osseous metastases may be enrolled).
2.Patients who have been confirmed to be positive for HER2.
3.Patients who have been diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects for gastric cancer.
4.Patients who were initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site.
5.Other patients judged by the investigators to be inappropriate for enrollment in this study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Kimijima |
Organization
Bristol-Myers Squibb K.K.
Division name
Japan Medical, Oncology Medical
Zip code
100-0004
Address
Otemachi One tower 1-2-1 Otemachi Chiyoda-ku Tokyo-to
TEL
03-6705-7388
Yuya.kimijima@bms.com
Public contact
Name of contact person
| 1st name | Mayu |
| Middle name | |
| Last name | Kakiuchi |
Organization
Mebix, Inc
Division name
Research Promotion Headquarters
Zip code
105-0001
Address
10F Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon 33 Mori Building
TEL
03-4362-4504
Homepage URL
G-KNIGHT@mebix.co.jp
Sponsor or person
Institute
Bristol-Myers Squibb K.K.
Ono Pharmaceutical CO.LTD.
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb K.K.
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
Mebix, Inc
Address
10F Toranomon, Minato-ku, Tokyo 3-8-21 Toranomon 33 Mori Building
Tel
03-4362-4504
G-KNIGHT@mebix.co.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 03 | 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
| 2021 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is designed as a descriptive epidemiological study.
Management information
Registered date
| 2022 | Year | 02 | Month | 03 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053423
