A Study to Learn About the Study Medicine (Avelumab) in Japanese Patients With Urothelial Carcinoma That Has Spread
- Registration Number
- NCT05431777
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 79
- 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).
There are no exclusion criteria for this study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma Avelumab Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma who were treated with avelumab as first-line maintenance therapy
- Primary Outcome Measures
Name Time Method Age of Participants at Baseline At baseline (at the initiation of avelumab maintenance therapy) The age of participants at baseline was reported.
Number of Participants With Advanced and Metastatic Urothelial Carcinoma by Sex At baseline (at the initiation of avelumab maintenance therapy) Number of Participants With Advanced and Metastatic UC by sex was reported.
Number of Participants According to Location of Primary Tumor At baseline (at the initiation of avelumab maintenance therapy) The primary tumor site is divided into the following categories: "upper urinary tract" for renal pelvis or ureter "lower urinary tract" for bladder and urethra.
Number of Participants With Presence of Urothelial Carcinoma Subtype At baseline (at the initiation of avelumab maintenance therapy) The subtype of urothelial carcinoma included micropapillary, microcystic, nested, lymphoepithelioma-like, plasmacytoid, sarcomatoid, giant cell, poorly differentiated, lipid rich, clear cell. number of participants with presence of UC subtype was reported.
Number of Participants With Metastatic Sites at Start of First Line Chemotherapy At baseline (at the initiation of avelumab maintenance therapy) Number of participants with metastatic sites at start of First Line Chemotherapy was reported.
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start of First Line Chemotherapy At the initiation of first line chemotherapy ECOG PS measured on-therapy (time between first dose and last dose date) assessed participant's performance status on 5 point scale: 0 is equal to (=) fully active/able to carry on all pre-disease activities without restriction; 1=restricted in physically strenuous activity, ambulatory/able to carry out light or sedentary work; 2=ambulatory (greater than \[\>\] 50% of waking hours \[hrs\]), capable of all self care, unable to carry out any work activities; 3=capable of only limited self care, confined to bed/chair \>50% of waking hrs; 4=completely disabled, cannot carry on any self care, totally confined to bed/chair; 5=dead.
Number of Participants Who Received First Line (IL) Chemotherapy Regimens At baseline (at the initiation of avelumab maintenance therapy) Chemotherapies were categorized as: 1.Gemcitabine + Cisplatin 2. Gemcitabine + Carboplatin 3. Dose-dense methotrexate, vinblastine, doxorubicin, cisplatin 4. Other.
Number of First Line Chemotherapy Cycles At baseline (at the initiation of avelumab maintenance therapy) Number of Firstline Chemotherapy Cycles in participants at baseline was reported.
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 At baseline (at the initiation of avelumab maintenance therapy) Determination of the best overall response to first-line chemotherapy is categorized as following: "Objective response" when "Complete Response" or "Partial Response." "Non-objective response" when "Stable Disease" of "Progressive Disease"
Number of Participants With Presence or Absence of Variant Histology At baseline (at the initiation of avelumab maintenance therapy) Number of participants with presence or absence of variant histology was reported.
Treatment-Free Interval At baseline (at the initiation of avelumab maintenance therapy) Treatment free-interval is defined as the time from the end date of first-line chemotherapy to the start date of avelumab administration. Treatment-free interval divided into the following categories. \<4 weeks/4 to 10 weeks/\>10 weeks.
Percentage of Participants With Second-Line Treatment Regimen At baseline (at the initiation of avelumab maintenance therapy) Second-Line Therapies were categorized as: 1. Platinum Chemotherapy, 2. Enfortumab Vedotin, Gem, Gemcitabine, 3.immune checkpoint inhibitor.
- Secondary Outcome Measures
Name Time Method Time to Failure (TTF) of Avelumab Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months TTF was 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) From index date up to 30 Jun 2022, where index date was date of first prescription for avelumab between 24 February 2021 and 30 November 2021 (maximum observation period was of 16 months approximately) rwPFS is defined as: 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 participants 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 participants undertaking only 1 line of therapy (only avelumab maintenance therapy) based on the record.
Overall Response Rate (ORR) Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months The Best ORR was defined as the percentage of participants having achieved complete response (CR) or partial response (PR) according to RECIST version 1.1 as determined by the IRC. CR: defined as disappearance of all target and all non-target lesions and no new lesions. PR: defined as at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters, no progression of non-target lesions and no new lesions.
Real-World Progression-Free Survival (Rw-PFS) From Chemotherapy (rwPFS-c） Time from start of avelumab maintenance therapy to the date of end of treatment due to any cause including death, assessed up to 5.9 months 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 participants 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 participants undertaking only 1 line of therapy (only avelumab maintenance therapy) based on the record.
Trial Locations
- Locations (16)
Akita University Hospital
🇯🇵Akita, Japan
Asahi General Hospital
🇯🇵Asahi, Chiba, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki, Gifu, Japan
SHOWA University Fujigaoka Hospital
🇯🇵Yokohama, Kanagawa, Japan
Kurume University Hospital
🇯🇵Kurume, Fukuoka, Japan
Nara Medical University Hospital
🇯🇵Kashihara, Nara, Japan
Osaka International Cancer Institute
🇯🇵Osaka-shi, Osaka, Japan
St. Marianna University School of Medicine
🇯🇵Kawasaki, Kanagawa, Japan
Hamamatsu University Hospital
🇯🇵Hamamatsu, Shizuoka, Japan
University Hospital Kyoto Prefectural University of Medicine IEC
🇯🇵Kyoto, Japan
Kyoto University Hospital
🇯🇵Kyoto, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Toyama University Hospital
🇯🇵Toyama, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Aichi, Japan
Kindai University Hospital
🇯🇵Osakasayama, Osaka, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan