JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study

Urothelial Carcinoma Clinical Trial

Official title:

A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06412848
• Other study ID #: MS100070_0209
• Status: Recruiting
• Start date: May 9, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: Communication Center
• Phone: +49 6151 72 5200
• Email: service[@]emdgroup.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• Avelumab
This is an observational study, participants who received avelumab as first line maintenance therapy after a PBCT.

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita
Japan	Juntendo University Hospital	Bunkyo-ku	Tokya
Japan	Nippon Medical School Hospital	Bunkyo-ku	Tokyo
Japan	National Cancer Center Hospital	Chuo-ku	Tokyo
Japan	Kyushu Cancer Center	Fukuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hirosaki University Hospital	Hirosaki	Aomori
Japan	Teikyo University Hospital	Itabashi-ku	Tokyo
Japan	Nara Medical University Hospital	Kashihara	Nara
Japan	St. Marianna University Hospital	Kawasaki	Kanagawa
Japan	Kagawa University Hospital	Kita-gun	Kagawa
Japan	Kobe University Hospital	Kobe	Hyogo
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	Osaka International Cancer Institute	Osaka
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Kitasato University Hospital	Sagamihara	Kanagawa
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Sapporo Medical University Hospital	Sapporo	Hokkaido
Japan	Iwate Medical University Hospital	Shiwa-gun	Iwate
Japan	Tokushima University Hospital	Tokushima
Japan	Ehime University Hospital	Toon	Ehime
Japan	Toyama University Hospital	Toyama
Japan	Yamagata University Hospital	Yamagata

Sponsors (1)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline clinical and demographic characteristics	To describe the baseline clinical and demographic characteristics of participants.	Baseline
Primary	Characteristics of the first line PBCT just prior to avelumab maintenance		Up to 3 months
Secondary	Overall Survival (OS)		Up to 3 months
Secondary	Progression-Free Survival (PFS)		Up to 3 months
Secondary	Time to Treatment Failure (TTF)		Up to 3 months
Secondary	Time to Next Treatment (TTNT)		Up to 3 months
Secondary	Objective Response Rate (ORR)		Up to 3 months