Urothelial CancerNCT05366725
A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy
An observational study of Urothelial Cancer, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 10 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer
- What is being tested?
- Avelumab
- How many people
- 106 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 29 Jun 2022to 27 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 -
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
University Hospitals Bristol
Bristol, BS1 3NU
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Royal Surrey County Hospital
Guildford, GU2 7XX
University College London Hospital
London, NW1 2PG
Guy's and St Thomas' Hospital
London, SE1 9RT
The Christie NHS Foundation Trust
Manchester, M20 4BX
Clatterbridge Hospital
Metropolitan Borough of Wirral, CH63 4JY
Churchill Hospital
Oxford, OX3 7LE
Royal Preston Hospital
Preston, PR2 9HT
Lister Hospital
Stevenage, SG1 4AB
About this study
Official title: A MULTI-CENTRE NON-INTERVENTIONAL STUDY TO DESCRIBE THE EARLY CLINICAL EXPERIENCE OF AVELUMAB USED AS MONOTHERAPY FOR THE FIRST-LINE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE PROGRESSION-FREE FOLLOWING PLATINUM-BASED CHEMOTHERAPY
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:
Read more
- Have UC that cannot be operated on or has spread to other parts of the body
- Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
- Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy
- Are 18 years or older on the date that they start taking Avelumab
All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.
Read the detailed description
The primary objective of this study is to estimate real-world overall survival (rwOS) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy.
The secondary objectives are:
- To describe the clinical and demographic characteristics of the study population
- To estimate real-world progression-free survival (rwPFS)
- To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy
- To describe treatment patterns after initiation of avelumab as 1L maintenance therapy
- To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population
- To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy
- Conditions
- Urothelial Cancer
- Being tested
- Avelumab
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 practice
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with locally advanced or metastatic urothelial cancer | Not described Receives: Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 from First Diagnosis to Locally Advanced or Metastatic Diagnosis is the time between date of first diagnosis and date of locally advanced or metastatic diagnosis. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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
Age (in years) at date of locally advanced or metastatic cancer diagnosis. Calculated as the number of years between date of birth and date of locally advanced or metastatic diagnosis, rounded down to the nearest whole year of age was reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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
The Stage of UC of participants at Locally Advanced or Metastatic Diagnosis was reported as recorded in eCRF Q13: Stage IIIA, Stage IIIB, Stage IVA or Stage IVB. Urothelial cancer stages III to IVB indicate progressive spread of the disease. In Stage IIIA, the cancer has invaded nearby tissues like the prostate, uterus, or vagina, or has reached one lymph node in the pelvis. Stage IIIB involves spread to two or more lymph nodes in that region. In Stage IVA, the cancer extends further to nearby organs such as the pelvic or abdominal wall, or to distant lymph nodes. Stage IVB represents the most advanced stage, where the cancer has metastasized to distant organs like the lungs, liver, or bones. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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
Participant's Histology at Locally Advanced or Metastatic Diagnosis was reported. Number of participants with histology of Pure urothelial cancer, mixed urothelial with component of another pathology, or other were reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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
Number of participants with de novo disease or newly relapsed at locally advanced or metastatic diagnosis was reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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 Programmed Death-Ligand 1 (PD-L1) Tumour Assessment Immune Cell (IC) Test Result at Locally Advanced or Metastatic Diagnosis
Participants PD-L1 tumour assessment immune cell (IC) test result at Locally Advanced or Metastatic Diagnosis was reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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 Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4
ECOG-PS assessed participant's performance status on a 5 point scale: 0= 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 (>50% of waking hours), 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 hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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: Participants Site of Metastases
Participants site of metastases: Lymph nodes, Bone, Lung, Liver, Peritoneum or other was reported. Participants could have one or more sites of metastases. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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 Prior Radical Treatment of Primary UC at Locally Advanced or Metastatic Diagnosis
The number of participants with prior radical treatment of primary UC at Locally Advanced or Metastatic Diagnosis were reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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 Prior Adjuvant or Neoadjuvant System Therapy at Locally Advanced or Metastatic Diagnosis
The number of participants with prior adjuvant or neoadjuvant system therapy at Locally Advanced or Metastatic Diagnosis were reported. Due to retrospective nature of study, the diagnosis data was collected retrospectively before participants were enrolled into the study, hence timeframe exceeds the study duration in this outcome measure.
Measured: 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)
Age of Participants at Avelumab Initiation
The age of participants at avelumab initiation was reported.
Measured: At Index date (date of avelumab initiation between September 2020 to November 2021 ) as reported in the eCRF.
Real-World Progression-Free Survival (Rw-PFS)
Rw-PFS is the time from the start date of avelumab treatment to the first date of either: any evidence of progression or date of death.
Measured: 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)
Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date
Number of participants who received type of First SACT regimen received were reported.
Measured: From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Number of First- Line Systematic Anti-Cancer Therapy (SACT) Cycles Received
Number of first line SACT cycles received by participants was reported as treatment characteristics.
Measured: From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Number of Participants Switching Between Different Platinum-Based Chemotherapies
Number of participants switching between different platinum-based chemotherapies were reported.
Measured: From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Time From Completion of First Line Systematic Anti-Cancer Therapy (SACT) to Start of Avelumab
Time from completion of first line SACT to start of avelumab was reported. Calculated as the number of days from the end date of the last first line SACT cycle to the start date of avelumab, inclusive of the start and end dates of this period.
Measured: From date of the last record of first line SACT to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Response to First Line Therapy
Response to first line therapy was reported. Response to first line SACT as reported in eCRF included: Complete Response (CR), Partial Response (PR) and Stable disease. The definitions of tumor responses are as follows: Complete or PR as the best adjudication result (CR > PR > stable disease [SD] > progressive disease [PD]) complies with the RECIST tumor assessment guidelines as closely as possible in clinical practice.
Measured: From date of first line SACT initiation to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Response to First-Line Therapy Based on Computed Tomography (CT) Scan Evidence
Response to First Line therapy based on CT scan evidence was reported. Response to first line SACT was judged based on CT scan evidence after the last cycle of first line SACT, as reported in eCRF. Reported as Yes or No.
Measured: From date of first line SACT initiation to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months)
Treatment Patterns: Duration of Treatment With Avelumab
Duration was derived based on the date of avelumab initiation and the last date of avelumab treatment.
Measured: From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) to end date of avelumab, or date of censoring (whichever is first), assessed upto 24 months after avelumab initiation
Treatment Patterns: Number of Participants Who Received Second-Line Therapy as Per eCRF
Number of participants who received second-line therapy were reported.
Measured: From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) and end of follow-up (upto 24 months after avelumab initiation)
Treatment Patterns: Time Interval Between Start of Avelumab and Start of Second-Line Therapy
Time interval was derived using the dates of avelumab initiation and initiation of first regimen of second line therapy. This parameter was calculated only among participants who go on to receive second-line therapy after avelumab initiation.
Measured: From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF)to start of second-line therapy assessed upto 24 months after avelumab initiation.
Treatment Patterns: Systematic Anti-Cancer Therapy Regimen Received as Second Line Therapy
Number of participants who received Systematic Anti-Cancer Therapy Regimen as Second Line Therapy was reported.
Measured: From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF and upto 24 months after avelumab initiation
Treatment Patterns: High Dose Systemic Steroid Use
Number of participants with high dose systemic steroid use was reported.
Measured: From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF up to 24 months after avelumab initiation
Number of Participants With Adverse Events (AEs) Explicitly Attributed to Avelumab in a Real-World Population
The number of separate AEs recorded per participants (with explicit linkage in the medical notes to avelumab) will be calculated using data from eCRF (each reported event on the eCRF counts as a separate AE).
Measured: 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)
Healthcare Resource Burden Associated With Avelumab Therapy: Accident and Emergency Visits
The number of accident and emergency visits recorded per participant as reported on the eCRF was used to calculate the rate of events per participant per year of follow-up time.
Measured: 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)
Healthcare Resource Burden Associated With Avelumab Therapy: Hospitalizations
The number of hospital admissions recorded per participant as reported on the eCRF was used to calculate the rate of events per participant per year of follow-up time
Measured: From participant electronic case report form (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)
Healthcare Resource Burden Associated With Avelumab Therapy: Participants Duration of Hospitalisation
Duration of Hospitalisation was reported.
Measured: Time from the start date of platinum-basedchemotherapeutic treatment to the earliest of date of death or date of censoring,as reported on the eCRF assessed up to 24 months from avelumab initiation (index date)
Real-World Overall Survival
Real world overall suvival was the time from the start date of platinum-based chemotherapeutic treatment to the earliest of date of death or date of censoring, as reported on the eCRF.
Measured: From participant electronic case report form (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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start29 Jun 2022
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366725
- Sponsor's protocol ID
- B9991047
- Status last verified
- Nov 2025
- First submitted
- 4 May 2022
- Last updated
- 2 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTI-CENTRE NON-INTERVENTIONAL STUDY TO DESCRIBE THE EARLY CLINICAL EXPERIENCE OF AVELUMAB USED AS MONOTHERAPY FOR THE FIRST-LINE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL CARCINOMA WHO ARE PROGRESSION-FREE FOLLOWING PLATINUM-BASED CHEMOTHERAPY
- ClinicalTrials.gov ID
- NCT05366725
- Acronym / sponsor ID
- B9991047
- Conditions
- Urothelial Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 2 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Have UC that cannot be operated on or has spread to other parts of the body
- Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
- Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy
- Are 18 years or older on the date that they start taking Avelumab
All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.
Detailed description
The primary objective of this study is to estimate real-world overall survival (rwOS) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy.
The secondary objectives are:
- To describe the clinical and demographic characteristics of the study population
- To estimate real-world progression-free survival (rwPFS)
- To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy
- To describe treatment patterns after initiation of avelumab as 1L maintenance therapy
- To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population
- To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with locally advanced or metastatic urothelial cancer | – | Drug: Avelumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAs provided in real world practice | Drug | Adult patients with locally advanced or metastatic urothelial cancer |
Primary outcome
Real-World Overall Survival
Time frame: 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)
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.
28 secondary outcomes
Clinical Characteristics: Time From First Diagnosis to Locally Advanced or Metastatic Diagnosis
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 Programmed Death-Ligand 1 (PD-L1) Tumour Assessment Immune Cell (IC) Test Result at Locally Advanced or Metastatic Diagnosis
Time frame: 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 Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4
Time frame: 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: Participants Site of Metastases
Time frame: 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 Prior Radical Treatment of Primary UC at Locally Advanced or Metastatic Diagnosis
Time frame: 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 Prior Adjuvant or Neoadjuvant System Therapy at Locally Advanced or Metastatic Diagnosis
Time frame: 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)
Age of Participants at Avelumab Initiation
Time frame: At Index date (date of avelumab initiation between September 2020 to November 2021 ) as reported in the eCRF.
Real-World Progression-Free Survival (Rw-PFS)
Time frame: 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)
Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date
Time frame: From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Number of First- Line Systematic Anti-Cancer Therapy (SACT) Cycles Received
Time frame: From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Number of Participants Switching Between Different Platinum-Based Chemotherapies
Time frame: From date of locally advanced or metastatic diagnosis to index date (Day 0) (avelumab initiation date between Sep 2020 to Nov 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Time From Completion of First Line Systematic Anti-Cancer Therapy (SACT) to Start of Avelumab
Time frame: From date of the last record of first line SACT to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Response to First Line Therapy
Time frame: From date of first line SACT initiation to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months)
Treatment Characteristics: Response to First-Line Therapy Based on Computed Tomography (CT) Scan Evidence
Time frame: From date of first line SACT initiation to index date (Day 0) (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) (Up to 24 months)
Treatment Patterns: Duration of Treatment With Avelumab
Time frame: From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) to end date of avelumab, or date of censoring (whichever is first), assessed upto 24 months after avelumab initiation
Treatment Patterns: Number of Participants Who Received Second-Line Therapy as Per eCRF
Time frame: From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF) and end of follow-up (upto 24 months after avelumab initiation)
Treatment Patterns: Time Interval Between Start of Avelumab and Start of Second-Line Therapy
Time frame: From (avelumab initiation date between September 2020 - November 2021 as reported in the eCRF)to start of second-line therapy assessed upto 24 months after avelumab initiation.
Treatment Patterns: Systematic Anti-Cancer Therapy Regimen Received as Second Line Therapy
Time frame: From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF and upto 24 months after avelumab initiation
Treatment Patterns: High Dose Systemic Steroid Use
Time frame: From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF up to 24 months after avelumab initiation
Number of Participants With Adverse Events (AEs) Explicitly Attributed to Avelumab in a Real-World Population
Time frame: 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)
Healthcare Resource Burden Associated With Avelumab Therapy: Accident and Emergency Visits
Time frame: 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)
Healthcare Resource Burden Associated With Avelumab Therapy: Hospitalizations
Time frame: From participant electronic case report form (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)
Healthcare Resource Burden Associated With Avelumab Therapy: Participants Duration of Hospitalisation
Time frame: Time from the start date of platinum-basedchemotherapeutic treatment to the earliest of date of death or date of censoring,as reported on the eCRF assessed up to 24 months from avelumab initiation (index date)
Real-World Overall Survival
Time frame: From participant electronic case report form (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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Trial Awareness and Transparency websiteLink provided by the sponsor.
- Medical Information Location Map - Med Info ContactsLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Cancer, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 10 sites in United Kingdom.
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 4 inclusion and 2 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 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. 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 2 Dec 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?
Real-World Overall Survival (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.