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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044090
Receipt No. 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 2021/05/01

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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
Email 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
Email horitano@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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 09087439753
Email 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
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 Preinitiation
Date of protocol fixation
2021 Year 05 Month 01 Day
Date of IRB
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
2021 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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