Clinical trial NCT05431777: A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread
Official title: Retrospective, Multicenter, Observational Study to Evaluate Current Treatment Patterns and Outcomes in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma Treated With First-line Avelumab Maintenance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urothelial Carcinoma
Keywords: Retrospective
Multicenter
Observational
current treatment patterns and outcome
Avelumab
Japan
Locally advanced or metastatic urothelial carcinoma
First-line therapy
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2022-06-24
Enrollment: 79
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic Urothelial Carcinoma treated with first-line avelumab maintenance therapy in Japan between 24 February 2021 and 30 November 2021

Brief summary: The purpose of this clinical trial is to learn about the current treatment patterns, safety, and effects of the study medicine (Avelumab) for the treatment of urothelial carcinoma.

This study is seeking Japanese participants who:

* have urothelial cancer that has spread
* are treated with Avelumab for maintenance

We will study the experiences of people receiving avelumab. This helps us learn the current treatment patterns, safety, and effects of avelumab. Participants will take part in this study up to 10 months. During this time, they will have no study visits.


Eligibility criteria: Inclusion Criteria:

1. Diagnosed with locally advanced or metastatic UC before receiving Avelumab 1L maintenance therapy.
2. Started treatment with avelumab for locally advanced or metastatic UC from 24 Feb 2021 (regulatory approval date) to 30 Nov 2021.
3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

(1) Written consent is not required for patients who were transferred to a hospital, and registration with verbal consent is acceptable.

(2) Opt-out enrollment is allowed for patients who have already died. 4)Deceased patients are also required to meet the inclusion criteria 1)-2).

Exclusion Criteria:

There are no exclusion criteria for this study.

Primary outcomes:
measure: Age of Participants at Baseline
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Number of Participants With Advanced and Metastatic Urothelial Carcinoma by Sex
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Number of Participants According to Location of Primary Tumor
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Number of Participants With Presence of Urothelial Carcinoma Subtype
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Number of Participants With Metastatic Sites at Start of First Line Chemotherapy
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of First Line Chemotherapy
timeFrame: At the initiation of first line chemotherapy
measure: Number of Participants Who Received First Line (IL) Chemotherapy Regimens
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Number of First Line Chemotherapy Cycles
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Number of Participants With Best Response to First Line Chemotherapy According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Number of Participants With Presence or Absence of Variant Histology
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Treatment-Free Interval
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
measure: Percentage of Participants With Second-Line Treatment Regimen
timeFrame: At baseline (at the initiation of avelumab maintenance therapy)
Secondary outcomes:
measure: Time to Failure (TTF) of Avelumab
timeFrame: Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months
measure: Real-World Progression-Free Survival (Rw-PFS)
timeFrame: From index date up to 30 Jun 2022, where index date was date of first prescription for avelumab between 24 February 2021 and 30 November 2021 (maximum observation period was of 16 months approximately)
measure: Overall Response Rate (ORR)
timeFrame: Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months
measure: Real-World Progression-Free Survival (Rw-PFS) From Chemotherapy (rwPFS-c）
timeFrame: Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: National Hospital Organization Nagoya Medical Center
state: Aichi
city: Asahi
country: Japan
facility: Asahi General Hospital
state: Chiba
city: Kurume
country: Japan
facility: Kurume University Hospital
state: Fukuoka
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
state: Gifu
city: Kawasaki
country: Japan
facility: St. Marianna University School of Medicine
state: Kanagawa
city: Yokohama
country: Japan
facility: SHOWA University Fujigaoka Hospital
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Osaka-shi
country: Japan
facility: Osaka International Cancer Institute
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital
state: Shizuoka
city: Akita
country: Japan
facility: Akita University Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine IEC
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Toyama
country: Japan
facility: Toyama University Hospital
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: