N/A
Completed N=79
A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread
Source: ClinicalTrials.gov NCT05431777 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcomePrimary: Age of Participants at Baseline — 72 Years
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Age of Participants at Baseline |
72 | — |
| PRIMARY Number of Participants With Advanced and Metastatic Urothelial Carcinoma by Sex |
60; 19 | — |
| PRIMARY Number of Participants According to Location of Primary Tumor |
43; 36 | — |
| PRIMARY Number of Participants With Presence of Urothelial Carcinoma Subtype |
33; 13; 20; 13 | — |
| PRIMARY Number of Participants With Metastatic Sites at Start of First Line Chemotherapy |
18; 34; 25; 2 | — |
| PRIMARY Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of First Line Chemotherapy |
56; 19; 3; 1; 0 | — |
| PRIMARY Number of Participants Who Received First Line (IL) Chemotherapy Regimens |
50; 24; 2; 3 | — |
| PRIMARY Number of First Line Chemotherapy Cycles |
4 | — |
| PRIMARY 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 |
8; 46; 25; 0 | — |
| PRIMARY Number of Participants With Presence or Absence of Variant Histology |
13; 33; 20; 13 | — |
| PRIMARY Treatment-Free Interval |
34 | — |
| PRIMARY Percentage of Participants With Second-Line Treatment Regimen |
51.4; 35.1; 8.1; 5.4 | — |
| SECONDARY Time to Failure (TTF) of Avelumab |
4.57 | — |
| SECONDARY Real-World Progression-Free Survival (Rw-PFS) |
6.10 | — |
| SECONDARY Overall Response Rate (ORR) |
31.6 | — |
| SECONDARY Real-World Progression-Free Survival (Rw-PFS) From Chemotherapy (rwPFS-c） |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosed with locally advanced or metastatic UC before receiving Avelumab 1L maintenance therapy.
- Started treatment with avelumab for locally advanced or metastatic UC from 24 Feb 2021 (regulatory approval date) to 30 Nov 2021.
- 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.
Data sourced from ClinicalTrials.gov (NCT05431777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.