UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046751 |
|---|---|
| Receipt number | R000053339 |
| Scientific Title | Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis |
| Date of disclosure of the study information | 2022/01/27 |
| Last modified on | 2024/04/03 14:05:15 |
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Basic information
Public title
Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis
Acronym
Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis
Scientific Title
Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis
Scientific Title:Acronym
Adverse events frequency caused by durvalumab and tremelimumab combination therapy: meta-analysis
Region
| Japan |
Condition
Condition
malignancies
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Numbers of clinical trials evaluated dual ICI therapy, durvalumab and tremelimumab combination. Although the safety profiles of durvalumab and tremelimumab have been reported in individual clinical trials, it is difficult to scrutinize frequencies of rare critical AEs using data of an individual trial. An increasing number of clinical studies on durvalumab and tremelimumab have been reported in particular since 2020, and there is a growing demand for accurate information on the AE caused by durvalumab and tremelimumab. Our systematic review was designed to assess per-person frequencies of AEs caused by durvalumab and tremelimumab administered for patients with malignancies.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequencies of AEs.
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
Patients with any malignancies who were treated with combined D+T are patients of interests. We will not question cancer type because our analysis will focus on AE but not efficacy.
We will collected AE data of D+T regimen regardless of dose, scheduling, maintenance therapy, and planned number of doses. Perioperative chemotherapy including both adjuvant and neoadjuvant treatment will be accepted.
Key exclusion criteria
Concurrent and sequential chemoradiotherapies will be excluded because anti-cancer drug dosage and safety profile are greatly deviated from D+T alone. Besides, regimen with three or more anti-cancer agents will not be allowed. Consequent treatment of D and T, for example, four doses of D followed by maintenance T, was excluded.
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, Fukuura, Kanazawa, Yokohama
TEL
+810081457872800
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, Fukuura, Kanazawa, Yokohama
TEL
+810081457872800
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
+810081457872800
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
| 2022 | Year | 01 | Month | 27 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/?term=%09durvalumab++tremelimumab+Nobuyuki+horita&sort=date
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/?term=%09durvalumab++tremelimumab+Nobuyuki+horita&sort=date
Number of participants that the trial has enrolled
3099
Results
See below:
Matsumoto H, Somekawa K, Horita N, et al. Adverse events induced by durvalumab and tremelimumab combination regimens: a systematic review and meta-analysis. Ther Adv Med Oncol. 2023. 13;15:17588359231198453.
Results date posted
| 2024 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
See below:
Matsumoto H, Somekawa K, Horita N, et al. Adverse events induced by durvalumab and tremelimumab combination regimens: a systematic review and meta-analysis. Ther Adv Med Oncol. 2023. 13;15:17588359231198453.
Participant flow
See below:
Matsumoto H, Somekawa K, Horita N, et al. Adverse events induced by durvalumab and tremelimumab combination regimens: a systematic review and meta-analysis. Ther Adv Med Oncol. 2023. 13;15:17588359231198453.
Adverse events
See below:
Matsumoto H, Somekawa K, Horita N, et al. Adverse events induced by durvalumab and tremelimumab combination regimens: a systematic review and meta-analysis. Ther Adv Med Oncol. 2023. 13;15:17588359231198453.
Outcome measures
See below:
Matsumoto H, Somekawa K, Horita N, et al. Adverse events induced by durvalumab and tremelimumab combination regimens: a systematic review and meta-analysis. Ther Adv Med Oncol. 2023. 13;15:17588359231198453.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Quality of each study will be assessed using The Newcastle-Ottawa Quality Assessment Scale for cohort studies.
Subgroup analyses focusing on history of previous anti-cancer drug treatment are planned.
We will apply a random-model meta-analysis and generic inverse variance method to aggregate binomial AE frequencies (RevMan ver 5.4. Cochrane Collaboration, London, UK). Agresti and Coull method will be used for standard error estimation. P value less than 0.05 was the criteria of statistical significance.
Management information
Registered date
| 2022 | Year | 01 | Month | 27 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053339
