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.

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. - JAVEMACS-D: Japan AVElumab Maintenance And Continuous treatment Study- Database study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031240122

Enrollment

900

Registered

2024-05-28

Start date

2024-05-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced or metastatic urothelial carcinoma (la/mUC) urothelial carcinoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1.Time to Treatment Failure (TTF), TTF2 2.Time to Next Treatment (TTNT), TTNT2 3.Overall Survival (OS)	—

Contacts

Public ContactMichihiro Shono

Merck Biopharma Co., Ltd.

michihiro.shono@merckgroup.com+81-3-6756-0800

Outcome results