JRCT ID: jRCT1031240122
Registered date:28/05/2024
Evaluation of avelumab maintenance therapy and subsequent treatment status in Japanese patients with locally advanced or metastatic urothelial carcinoma using a large-scale database in Japan.
Basic Information
| Recruitment status | Not Recruiting |
|---|---|
| Health condition(s) or Problem(s) studied | Locally advanced or metastatic urothelial carcinoma (la/mUC) |
| Date of first enrollment | 28/05/2024 |
| Target sample size | 900 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | 1.Describe the baseline demographics and clinical characteristics of patients received avelumab maintenance with la/m UC 2.Describe the characteristics of first PBCT prior to avelumab maintenance 3.Describe number and proportion of patients who transitioned to subsequent treatments (second, third and fourth) after avelumab maintenance |
|---|---|
| Secondary Outcome | 1.Time to Treatment Failure (TTF), TTF2 2.Time to Next Treatment (TTNT), TTNT2 3.Overall Survival (OS) |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | Both |
| Include criteria | Individuals can be included in the study only if they meet all the following criteria: 1.Confirmed diagnosis of UC in either the renal pelvis, ureter, bladder, or other and unspecified urinary organs based on ICD-10 code (C65-68) before the index date 2.Patient who was prescribed a first dose of avelumab between 24th February 2021 and 30th April 2023 3.Patient aged 18 years old or older at the index date |
| Exclude criteria | Individuals are excluded from the study if they meet any of the following criteria: 1.Patient with no prescribed history of platinum-based combination chemotherapy (PBCT) prior to the start of avelumab prescription 2.Patient who are considered to have received any combination therapy of avelumab and anti-cancer agents 3.Considered to have participated in a clinical trial in la/m UC at any time during the study period |
Related Information
| Primary Sponsor | Ito Takayuki |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Merck Biopharma Co., Ltd. |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Michihiro Shono |
| Address | Meguro-ku Shimomeguro 1-8-1 Alco Tower 4F Tokyo Japan 153-0064 |
| Telephone | +81-3-6756-0800 |
| michihiro.shono@merckgroup.com | |
| Affiliation | Merck Biopharma Co., Ltd. |
| Scientific contact | |
| Name | Takayuki Ito |
| Address | Meguro-ku Shimomeguro 1-8-1 Alco Tower 4F Tokyo Japan 153-0064 |
| Telephone | +81-3-6756-0800 |
| takayuki.ito@merckgroup.com | |
| Affiliation | Merck Biopharma Co., Ltd. |