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Urothelial CarcinomaNCT05431777

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

An observational study of Urothelial Carcinoma, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 16 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 0 years and older
Conditions the study is for
Urothelial Carcinoma
What is being tested?
Avelumab
How many people
79 participants
Where
16 sitesJapan
Study dates
19 Jul 2022to 16 Jan 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Patients with locally advanced or metastatic Urothelial Carcinoma treated with first-line avelumab maintenance therapy in Japan between 24 February 2021 and 30 November 2021

Who may be able to join

  • 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.
  • Written consent is not required for patients who were transferred to a hospital, and registration with verbal consent is acceptable.
  • Opt-out enrollment is allowed for patients who have already died. 4)Deceased patients are also required to meet the inclusion criteria 1)-2).

Who cannot join

  • There are no exclusion criteria for this study.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

Japan16 sites

  • Akita University Hospital

    Akita, 010-8543

  • Asahi General Hospital

    Asahi, Chiba, 289-2511

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Nara Medical University Hospital

    Kashihara, Nara, 634-8522

  • St. Marianna University School of Medicine

    Kawasaki, Kanagawa, 216-8511

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine IEC

    Kyoto, 602-8566

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • Ogaki Municipal Hospital

    Ōgaki, Gifu, 503-8502

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Kindai University Hospital

    Sayama, Osaka, 589-8511

  • Toyama University Hospital

    Toyama, 930-0194

  • SHOWA University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8501

Other trials in Japan

About this study

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

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.

Being tested
Avelumab
Keywords
Retrospective, Multicenter, Observational, current treatment patterns and outcome, Avelumab, Japan, Locally advanced or metastatic urothelial carcinoma, First-line therapy
Medical subject headings
Carcinoma, Transitional Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AvelumabDrug

    As provided in real world setting

Study groups in NCT05431777
Study groupRoleWhat they receive
Japanese Patients With Locally Advanced or Metastatic Urothelial CarcinomaJapanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma who were treated with avelumab as first-line maintenance therapy
Receives: Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Age of Participants at Baseline

    The age of participants at baseline was reported.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  2. Number of Participants With Advanced and Metastatic Urothelial Carcinoma by Sex

    Number of Participants With Advanced and Metastatic UC by sex was reported.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  3. Number of Participants According to Location of Primary Tumor

    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.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  4. Number of Participants With Presence of Urothelial Carcinoma Subtype

    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.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  5. Number of Participants With Metastatic Sites at Start of First Line Chemotherapy

    Number of participants with metastatic sites at start of First Line Chemotherapy was reported.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  6. Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) at Start 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.

    Measured: At the initiation of first line chemotherapy

  7. Number of Participants Who Received First Line (IL) Chemotherapy Regimens

    Chemotherapies were categorized as: 1.Gemcitabine + Cisplatin 2. Gemcitabine + Carboplatin 3. Dose-dense methotrexate, vinblastine, doxorubicin, cisplatin 4. Other.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  8. Number of First Line Chemotherapy Cycles

    Number of Firstline Chemotherapy Cycles in participants at baseline was reported.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  9. 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

    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"

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  10. Number of Participants With Presence or Absence of Variant Histology

    Number of participants with presence or absence of variant histology was reported.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  11. Treatment-Free Interval

    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.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

  12. Percentage of Participants With Second-Line Treatment Regimen

    Second-Line Therapies were categorized as: 1. Platinum Chemotherapy, 2. Enfortumab Vedotin, Gem, Gemcitabine, 3.immune checkpoint inhibitor.

    Measured: At baseline (at the initiation of avelumab maintenance therapy)

Secondary outcomes (4)

  1. Time to Failure (TTF) of Avelumab

    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.

    Measured: 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

  2. Real-World Progression-Free Survival (Rw-PFS)

    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.

    Measured: 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)

  3. Overall Response Rate (ORR)

    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.

    Measured: 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

  4. Real-World Progression-Free Survival (Rw-PFS) 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 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.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2022
  2. Study start19 Jul 2022
  3. Primary completion16 Jan 2023
  4. Study completion16 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05431777
Sponsor's protocol ID
B9991048
Status last verified
Mar 2025
First submitted
20 Jun 2022
Last updated
1 Apr 2025
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

Publications

  • Kikuchi E, Hayakawa N, Nakayama M, Uno M, Nakatsu H, Kitagawa C, Miyake H, Yamada T, Fujita K, Shimoyama H, Nishihara K, Kobayashi M, Nakamura M, Fujimoto K, Sano T, Nishiyama N, Ito T, Kajita M, Kobayashi T, Kitamura H. J-AVENUE: A retrospective, real-world study evaluating patient characteristics and outcomes in patients with advanced urothelial carcinoma treated with avelumab first-line maintenance therapy in Japan. Int J Urol. 2024 Aug;31(8):859-867. doi: 10.1111/iju.15473. Epub 2024 May 9.

    PubMed 38722221

Questions about this trial

What is this clinical trial studying?

An observational study of Urothelial Carcinoma, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 16 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Age of Participants at Baseline (time frame: At baseline (at the initiation of avelumab maintenance therapy)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05431777, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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