A Study to Learn About First-line Avelumab Maintenance in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

• Sponsor: Pfizer (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05431777
• Collaborator: (none)
• Enrollment: 100
• Locations: 15
• Anticipated Duration (Months): 8.9
• Patients Per Site: 6.7
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The purpose of this study 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 locally advanced or metastatic urothelial carcinoma treated with first-line avelumab maintenance.

We will examine the experiences of people receiving avelumab. This helps us learn the current treatment patterns, safety, and effects of avelumab.

This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic urothelial carcinoma patients who were treated with avelumab as first-line maintenance therapy between 24 February 2021 and 30 November 2021 in Japan. Participants will take part in this study up to 10 months. During this time, they will have no study visits.

Condition or Disease	Intervention/Treatment	Phase
Urothelial Carcinoma	Drug: Avelumab

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Apr 30, 2023
• Anticipated Study Completion Date: Apr 30, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Description of patient characteristics at baseline [24 February 2021 to 30 November 2021]

Secondary Outcome Measures

1. Time to Failure (TTF) [24 February 2021 to 30 November 2021]

   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.

2. Real-World Progression-Free Survival (rw-PFS) [24 February 2021 to 30 November 2021]

   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.

3. Objective Response - Number of Participants With Objective Response [24 February 2021 to 30 November 2021]

   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.

4. rwPFS from chemotherapy (rwPFS-c） [24 February 2021 to 30 November 2021]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Hospital Organization Nagoya Medical Center	Nagoya	Aichi	Japan	460-0001
2	Asahi General Hospital	Asahi	Chiba	Japan	289-2511
3	Kurume University Hospital	Kurume	Fukuoka	Japan	830-0011
4	Ogaki Municipal Hospital	Ogaki	Gifu	Japan	503-8502
5	St. Marianna University School of Medicine	Kawasaki	Kanagawa	Japan	216-8511
6	SHOWA University Fujigaoka Hospital	Yokohama	Kanagawa	Japan	227-8501
7	Nara Medical University Hospital	Kashihara	Nara	Japan	634-8522
8	Osaka International Cancer Institute	Osaka-shi	Osaka	Japan	541-8567
9	Kindai University Hospital	Osakasayama	Osaka	Japan	589-8511
10	Hamamatsu University School of Medicine University Hospital	Hamamatsu	Shizuoka	Japan	431-3192
11	Akita University Hospital	Akita		Japan	010-8543
12	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
13	University Hospital Kyoto Prefectural University of Medicine	Kyoto		Japan	602-8566
14	Kyoto University Hospital	Kyoto		Japan	606-8507
15	Toyama University Hospital	Toyama		Japan	930-0194

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05431777
• Other Study ID Numbers: B9991048
• First Posted: Jun 24, 2022
• Last Update Posted: Jul 22, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Pfizer: Retrospective; Multicenter; Observational; current treatment patterns and outcome; Avelumab; Japan; Locally advanced or metastatic urothelial carcinoma; First-line therapy
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Transitional Cell; Avelumab

Study Results

No Results Posted as of Jul 22, 2022