JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

Merck KGaA (EMD Serono)

Status: Active, not recruiting

Conditions: Urothelial Carcinoma

Treatments: Drug: Avelumab

Study type: Observational

Funder types: Industry

Identifiers

NCT06412848

MS100070_0209

Details and patient eligibility

About

This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes.

Enrollment: 360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m UC) before receiving avelumab first line maintenance therapy
• Participants with la/m UC (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line PBCT and who has been treated with avelumab
• Participants who has been started avelumab first line maintenance therapy for la/m UC from 24 Feb 2021 (date of approval for UC) to 6 months before the date of approval of implementation of this study at each site
• Participants aged >= 18 years old at index date
• Other protocol defined inclusion criteria could apply

Exclusion criteria

• Participant participated in a clinical trial in la/m UC during the study periods.

Trial design

360 participants in 1 patient group

Urothelial Carcinoma Cohort

Description:

This is a single cohort study enrolling Participants with Urothelial Carcinoma (UC), who are prescribed treatment with avelumab as first line maintenance therapy after a platinum-based chemotherapy (PBCT).

Treatment:

Drug: Avelumab