A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread

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

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.

Study Overview

• Status: Completed
• Conditions: Urothelial Carcinoma
• Intervention / Treatment: Drug: Avelumab

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• Japan
  • Akita, Japan, 010-8543
    • Akita University Hospital
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine IEC
  • Toyama, Japan, 930-0194
    • Toyama University Hospital
  • Aichi
    • Nagoya, Aichi, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center
  • Chiba
    • Asahi, Chiba, Japan, 289-2511
      • Asahi General Hospital
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Gifu
    • Ogaki, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 216-8511
      • St. Marianna University School of Medicine
    • Yokohama, Kanagawa, Japan, 227-8501
      • Showa University Fujigaoka Hospital
  • Nara
    • Kashihara, Nara, Japan, 634-8522
      • Nara Medical University Hospital
  • Osaka
    • Osaka-shi, Osaka, Japan, 541-8567
      • Osaka International Cancer Institute
    • Osakasayama, Osaka, Japan, 589-8511
      • Kindai University Hospital
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma; Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma who were treated with avelumab as first-line maintenance therapy	Drug: Avelumab; As provided in real world setting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Description of patient characteristics at baseline	24 February 2021 to 30 November 2021

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Failure (TTF)	TTF is defined as the following: TTF, defined as the time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death. If there is no record of the end of treatment, it be discontinued on the last visit date during the study period.	24 February 2021 to 30 November 2021
Real-World Progression-Free Survival (rw-PFS)	rwPFS is defined as the following: The time from start of avelumab maintenance therapy to date of first disease progression (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause, whichever occurred first. If there were no clinical records of death or disease progression, they will be censored at the date of initiation of the next line of therapy for the patients undertaking 2 or more lines of therapy (subsequent therapy after avelumab maintenance therapy) based on the record, or at their last visit date during the study period for the patients undertaking only 1 line of therapy (only avelumab maintenance therapy) based on the record.	24 February 2021 to 30 November 2021
Objective Response - Number of Participants With Objective Response	Objective Response is defined as the following: Complete or partial response as the best adjudication result (CR > PR > SD > PD) in a method that complies with Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1 tumor assessment as closely as possible in clinical practice by investigator's judgment.	24 February 2021 to 30 November 2021
rwPFS from chemotherapy (rwPFS-c）	rwPFS-c is defined as the following: The time from start of first-line Chemotherapy to date of first disease progression (as clinically assessed by local investigator based on radiology, laboratory evidence, pathology, or other assessments) or death due to any cause during avelumab treatment, whichever occurred first. If there were no clinical records of death or disease progression, they will be censored at the date of initiation of the next line of therapy for the patients undertaking 2 or more lines of therapy (subsequent therapy after avelumab maintenance therapy) based on the record, or at their last visit date during the study period for the patients undertaking only 1 line of therapy (only avelumab maintenance therapy) based on the record.	24 February 2021 to 30 November 2021

Collaborators and Investigators

• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

• Trial Awareness and Transparency website

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Actual): January 16, 2023
• Study Completion (Actual): January 16, 2023

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 20, 2022
• First Posted (Actual): June 24, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Avelumab; Observational; Japan; Multicenter; Retrospective; First-line therapy; current treatment patterns and outcome; Locally advanced or metastatic urothelial carcinoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Avelumab
• Other Study ID Numbers: B9991048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No