A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

NCT05366725 | Completed Results

• 1 other identifier: B9991047
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Avelumab) in people with advanced urothelial (bladder) cancer (UC) whose disease hasn't worsened after receiving chemotherapy. This study is seeking participants who:

1. 1.Have UC that cannot be operated on or has spread to other parts of the body
2. 2.Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
3. 3.Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy
4. 4.Are 18 years or older on the date that they start taking Avelumab

Conditions

Urothelial Cancer

Outcome Measures

Primary Outcomes (1)

• Real-World Overall Survival

  Real-World Overall Survival is the time from participant eCRF index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring, inclusive of start and end date. Analysis was performed using Kaplan-Meier method.

  From participant eCRF index date (avelumab initiation between September 2020 to November 2021) to date of death by any cause, or date of censoring (whichever is first) (up to 24-months from initiation of avelumab treatment)

Secondary Outcomes (28)

• Clinical Characteristics: Time From First Diagnosis to Locally Advanced or Metastatic Diagnosis

  Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks)

• Clinical Characteristics: Participant's Age at Locally Advanced or Metastatic Diagnosis

  Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks)

• Clinical Characteristics: Participant's Stage of UC at Locally Advanced or Metastatic Diagnosis

  Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks)

• Clinical Characteristics: Participant's Histology at Locally Advanced or Metastatic Diagnosis

  Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks)

• Clinical Characteristics: Number of Participants With De Novo Disease or Newly Relapsed at Locally Advanced or Metastatic Diagnosis

  Time between date of first diagnosis and date of locally advanced or metastatic diagnosis measured at baseline (date of locally advanced or metastatic diagnosis) (Up to 621.4 weeks)

Study Arms (1)

Adult patients with locally advanced or metastatic urothelial cancer

Drug: Avelumab

Interventions

Avelumab DRUG

As provided in real world practice

Adult patients with locally advanced or metastatic urothelial cancer

Eligibility Criteria

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

Study Population

Adult patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed who are progression-free following completion of platinum-based chemotherapy.

You may qualify if:

• Patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed
• Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
• Patients received avelumab as indicated as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy
• Patients aged ≥18 years on the date that they commenced avelumab -

You may not qualify if:

• Patients whose hospital records are not available for review
• Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab

Sponsors & Collaborators

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

Study Sites (10)

University Hospitals Bristol

Bristol, BS1 3NU, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Location

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

Location

University College London Hospital

London, NW1 2PG, United Kingdom

Location

Guy's and St Thomas' Hospital

London, SE1 9RT, United Kingdom

Location

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

Location

Clatterbridge Hospital

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Churchill Hospital

Oxford, OX3 7LE, United Kingdom

Location

Royal Preston Hospital

Preston, PR2 9HT, United Kingdom

Location

Lister Hospital

Stevenage, SG1 4AB, United Kingdom

Location

Related Links

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

MeSH Terms

Interventions

avelumab

Results Point of Contact

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

service@emdgroup.com

+49 06151725200

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: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: June 29, 2022
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: December 2, 2025
• Results First Posted: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (10)