A Study to Learn About First-line Avelumab Maintenance in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
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 |
---|---|---|
Study Design
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
- Description of patient characteristics at baseline [24 February 2021 to 30 November 2021]
Secondary Outcome Measures
- 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.
- 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.
- 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.
- 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
Inclusion Criteria:
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Diagnosed with locally advanced or metastatic UC before receiving Avelumab 1L maintenance therapy.
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Started treatment with avelumab for locally advanced or metastatic UC from 24 Feb 2021 (regulatory approval date) to 30 Nov 2021.
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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.- B9991048