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

Urothelial Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05431777
• Other study ID #: B9991048
• Status: Completed
• Start date: July 19, 2022
• Est. completion date: January 16, 2023

Study information

• Verified date: October 2023
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 16, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• Avelumab
As provided in real world setting

Locations

Country	Name	City	State
Japan	Akita University Hospital	Akita
Japan	Asahi General Hospital	Asahi	Chiba
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Nara Medical University Hospital	Kashihara	Nara
Japan	St. Marianna University School of Medicine	Kawasaki	Kanagawa
Japan	Kurume University Hospital	Kurume	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto
Japan	University Hospital Kyoto Prefectural University of Medicine IEC	Kyoto
Japan	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi
Japan	Ogaki Municipal Hospital	Ogaki	Gifu
Japan	Osaka International Cancer Institute	Osaka-shi	Osaka
Japan	Kindai University Hospital	Osakasayama	Osaka
Japan	Toyama University Hospital	Toyama
Japan	SHOWA University Fujigaoka Hospital	Yokohama	Kanagawa

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	Description of patient characteristics at baseline		24 February 2021 to 30 November 2021
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Trial Awareness and Transparency website