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

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 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

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

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