JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

Active, not recruiting

• Conditions: Urothelial Carcinoma
• Interventions: Drug: Avelumab

• Registration Number: NCT06412848
• Lead Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-23
• Study Start: 2024-05-09
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Urothelial Carcinoma Cohort	Avelumab	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).

Primary Outcome Measures

Name	Time	Method
Characteristics of the first line PBCT just prior to avelumab maintenance	Up to 3 months
Baseline clinical and demographic characteristics	Baseline	To describe the baseline clinical and demographic characteristics of participants.

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 3 months
Progression-Free Survival (PFS)	Up to 3 months
Overall Survival (OS)	Up to 3 months
Time to Treatment Failure (TTF)	Up to 3 months
Time to Next Treatment (TTNT)	Up to 3 months

Trial Locations

Locations (26)

Hirosaki University Hospital; 🇯🇵 Hirosaki, Aomori, Japan

Ehime University Hospital; 🇯🇵 Toon, Ehime, Japan

Kurume University Hospital; 🇯🇵 Kurume, Fukuoka, Japan

Hokkaido University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Sapporo Medical University Hospital; 🇯🇵 Sapporo, Hokkaido, Japan

Kobe University Hospital; 🇯🇵 Kobe, Hyogo, Japan

Iwate Medical University Hospital; 🇯🇵 Shiwa-gun, Iwate, Japan

Kagawa University Hospital; 🇯🇵 Kita-gun, Kagawa, Japan

St. Marianna University Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan

Kitasato University Hospital; 🇯🇵 Sagamihara, Kanagawa, Japan

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