Clinical trial NCT06412848: JAVEMACS: Japan AVElumab Maintenance And Continuous Treatment Study
Official title: A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Urothelial Carcinoma
Keywords: Urothelial Carcinoma
Avelumab
JAVEMACS
Locally advanced UC
Metastatic UC
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2024-05-14
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with locally advanced/metastatic Urothelial Carcinoma

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Baseline clinical and demographic characteristics
timeFrame: Baseline
measure: Characteristics of the first line PBCT just prior to avelumab maintenance
timeFrame: Up to 3 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 3 months
measure: Progression-Free Survival (PFS)
timeFrame: Up to 3 months
measure: Time to Treatment Failure (TTF)
timeFrame: Up to 3 months
measure: Time to Next Treatment (TTNT)
timeFrame: Up to 3 months
measure: Objective Response Rate (ORR)
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Hirosaki
country: Japan
facility: Hirosaki University Hospital
state: Aomori
city: Toon
country: Japan
facility: Ehime University Hospital
state: Ehime
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
state: Hokkaido
city: Kobe
country: Japan
facility: Kobe University Hospital
state: Hyogo
city: Shiwa-gun
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Kawasaki
country: Japan
facility: St. Marianna University Hospital
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokya
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital
state: Tokyo
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: Kyushu Cancer Center
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Osaka
country: Japan
facility: Osaka International Cancer Institute
city: Tokushima
country: Japan
facility: Tokushima University Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: