UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044090 |
|---|---|
| Receipt number | R000050350 |
| Scientific Title | Adverse events frequency caused by nivolumab and ipilimumab combination therapy: meta-analysis |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2022/04/29 11:06:50 |
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Basic information
Public title
Adverse events frequency caused by nivolumab and ipilimumab combination therapy: meta-analysis
Acronym
Adverse events frequency caused by nivolumab and ipilimumab combination therapy: meta-analysis
Scientific Title
Adverse events frequency caused by nivolumab and ipilimumab combination therapy: meta-analysis
Scientific Title:Acronym
Adverse events frequency caused by nivolumab and ipilimumab combination therapy: meta-analysis
Region
| Japan |
Condition
Condition
cancers
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify per-person frequencies of adverse events due to Niv+Ipi used for chemo-naive ICI-naive cases.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Per-person frequencies of any AE (any grade, Grade 3 or higher(G3-)), serious AE (any grade, Grade 3 or higher), AE discontinuation (any grade, Grade 3 or higher), treatment-related death.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cancer type is not questioned since safety profile is not largely affected by cancer type as long as the same regimen was selected. Patients should not be previously treated by any anti-cancer medications such as cytotoxic drugs, molecular targeted therapy, and ICIs. No restriction is set for performance status and age.
Key exclusion criteria
None
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2800
horitano@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University Hospital
Division name
Chemotherapy Center
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2800
Homepage URL
horitano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital
Address
3-9, Fukuura, Kanazawa, Yokohama
Tel
0457872800
horitano@yokohama-cu.ac.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
| 2021 | Year | 05 | 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
4677
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
Main results already published
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search formula for PubMed: (ipilimumab[title] or Yervoy[title]) (nivolumab[title] or Opdivo[title]) (first-line or 1st-line or front line or 1L or untreated or naive or chemo-naive or naive or chemo-naive or adjuvant or postoperative or neoadjuvant or preoperative or perioperative).
We will allow randomized trials, single-arm trials, prospective observational trials, and retrospective studies; however, case reports and case series with five or less cases will not be used because these study designs are suitable to estimate adverse event frequency. Eligible article should be written in English language. Both full article and conference abstract are permitted.
Cancer type will not be questioned since safety profile is not largely affected by cancer type as long as the same regimen is selected. Patients should not be previously treated by any anti-cancer medications such as cytotoxic drugs, molecular targeted therapy, and ICIs. No restriction is set for performance status and age. Patients after transplantation were excluded.
Treatment of our concern is Niv+Ipi combination therapy regardless of dosing and scheduling. Concomitant administration of cytotoxic agents, molecular-targeted medications, and other ICIs will be prohibited for our analysis. Dose, scheduling, and a total number of administrations of Niv+Ipi regimen are not questioned. Concurrent radiotherapy was not allowed for our analysis.
Key outcomes are per-person frequencies of any AE (any grade, Grade 3 or higher(G3-)), serious AE (any grade, Grade 3 or higher), AE discontinuation (any grade, Grade 3 or higher), treatment-related death.
Regimen based subgroup analyses is planned.
The frequency of each AE will be pooled using random-model meta-analysis using generic inverse variance methods.
Standard error will be calculated using Agrestia method.
Management information
Registered date
| 2021 | Year | 05 | Month | 01 | Day |
Last modified on
| 2022 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050350
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/04/29 | somekawa ae.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/04/29 | somekawa ae.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/04/29 | somekawa ae.pdf |
Single case data URL
Value
https://center6.umin.ac.jp/ice/50350
