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

NCT05431777 | Completed Results

• 1 other identifier: B9991048
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 16

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.

Conditions

Urothelial Carcinoma

Keywords

Retrospective; Multicenter; Observational; current treatment patterns and outcome; Avelumab; Japan; Locally advanced or metastatic urothelial carcinoma; First-line therapy

Outcome Measures

Primary Outcomes (12)

• Age of Participants at Baseline

  The age of participants at baseline was reported.

  At baseline (at the initiation of avelumab maintenance therapy)

• Number of Participants With Advanced and Metastatic Urothelial Carcinoma by Sex

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

  At baseline (at the initiation of avelumab maintenance therapy)

• 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.

  At baseline (at the initiation of avelumab maintenance therapy)

• 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.

  At baseline (at the initiation of avelumab maintenance therapy)

• 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.

  At baseline (at the initiation of avelumab maintenance therapy)

• 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.

  At the initiation of first line chemotherapy

• 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.

  At baseline (at the initiation of avelumab maintenance therapy)

• Number of First Line Chemotherapy Cycles

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

  At baseline (at the initiation of avelumab maintenance therapy)

• 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"

  At baseline (at the initiation of avelumab maintenance therapy)

• Number of Participants With Presence or Absence of Variant Histology

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

  At baseline (at the initiation of avelumab maintenance therapy)

• 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.

  At baseline (at the initiation of avelumab maintenance therapy)

• 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.

  At baseline (at the initiation of avelumab maintenance therapy)

Secondary Outcomes (4)

• 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

• 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)

• 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

• 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

Study Arms (1)

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

Interventions

Avelumab DRUG

As provided in real world setting

Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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.

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (16)

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, 460-0001, Japan

Location

Asahi General Hospital

Asahi, Chiba, 289-2511, Japan

Location

Kurume University Hospital

Kurume, Fukuoka, 830-0011, Japan

Location

Ogaki Municipal Hospital

Ōgaki, Gifu, 503-8502, Japan

Location

St. Marianna University School of Medicine

Kawasaki, Kanagawa, 216-8511, Japan

Location

SHOWA University Fujigaoka Hospital

Yokohama, Kanagawa, 227-8501, Japan

Location

Nara Medical University Hospital

Kashihara, Nara, 634-8522, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Kindai University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Hamamatsu University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Akita University Hospital

Akita, 010-8543, Japan

Location

National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

University Hospital Kyoto Prefectural University of Medicine IEC

Kyoto, 602-8566, Japan

Location

University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Kyoto University Hospital

Kyoto, 606-8507, Japan

Location

Toyama University Hospital

Toyama, 930-0194, Japan

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

avelumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 24, 2022
• Study Start: July 19, 2022
• Primary Completion: January 16, 2023
• Study Completion: January 16, 2023
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (16)