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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05366725

Enrollment

106

Registered

2022-05-09

Start date

2022-06-29

Completion date

2024-06-27

Last updated

2025-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Cancer

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. Have UC that cannot be operated on or has spread to other parts of the body 2. Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment 3. Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy 4. 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: 1. To describe the clinical and demographic characteristics of the study population 2. To estimate real-world progression-free survival (rwPFS) 3. To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy 4. To describe treatment patterns after initiation of avelumab as 1L maintenance therapy 5. To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population 6. To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy

Interventions

DRUGAvelumab

As provided in real world practice

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed 2. Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment 3. 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 4. Patients aged ≥18 years on the date that they commenced avelumab -

Exclusion criteria

1. Patients whose hospital records are not available for review 2. Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab

Design outcomes

Primary

Measure	Time frame	Description
Real-World Overall Survival	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.

Secondary

Measure	Time frame	Description
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)	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.
Treatment Characteristics: Type of First Systemic Anticancer Treatment (SACT) Regimen Received Before Avelumab Start Date	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)	Number of participants who received type of First SACT regimen received were reported.
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)	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.
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)	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.
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)	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.
Clinical Characteristics: Participant's Programmed Death-Ligand 1 (PD-L1) Tumour Assessment Immune Cell (IC) Test Result 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)	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.
Clinical Characteristics: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 and 2, 3 or 4	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)	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.
Clinical Characteristics: Participants Site of Metastases	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)	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.
Clinical Characteristics: Number of Participants With Prior Radical Treatment of Primary 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)	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.
Clinical Characteristics: Number of Participants With Prior Adjuvant or Neoadjuvant System Therapy 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)	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.
Age of Participants at Avelumab Initiation	At Index date (date of avelumab initiation between September 2020 to November 2021 ) as reported in the eCRF.	The age of participants at avelumab initiation was reported.
Real-World Progression-Free Survival (Rw-PFS)	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)	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.
Treatment Characteristics: Number of First- Line Systematic Anti-Cancer Therapy (SACT) Cycles Received	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)	Number of first line SACT cycles received by participants was reported as treatment characteristics.
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)	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.
Treatment Characteristics: Time From Completion of First Line Systematic Anti-Cancer Therapy (SACT) to Start of Avelumab	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)	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.
Treatment Characteristics: Response to First Line Therapy	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)	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.
Treatment Characteristics: Response to First-Line Therapy Based on Computed Tomography (CT) Scan Evidence	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)	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.
Treatment Patterns: Duration of Treatment With Avelumab	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	Duration was derived based on the date of avelumab initiation and the last date of avelumab treatment.
Treatment Patterns: Number of Participants Who Received Second-Line Therapy as Per eCRF	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)	Number of participants who received second-line therapy were reported.
Treatment Patterns: Time Interval Between Start of Avelumab and Start of Second-Line Therapy	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.	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.
Treatment Patterns: Systematic Anti-Cancer Therapy Regimen Received as Second Line Therapy	From avelumab initiation date between September 2020 - November 2021 as reported in the eCRF and upto 24 months after avelumab initiation	Number of participants who received Systematic Anti-Cancer Therapy Regimen as Second Line Therapy was reported.
Treatment Patterns: High Dose Systemic Steroid Use	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 high dose systemic steroid use was reported.
Number of Participants With Adverse Events (AEs) Explicitly Attributed to Avelumab in a Real-World Population	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)	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).
Healthcare Resource Burden Associated With Avelumab Therapy: Accident and Emergency Visits	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)	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.
Healthcare Resource Burden Associated With Avelumab Therapy: Hospitalizations	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)	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
Healthcare Resource Burden Associated With Avelumab Therapy: Participants Duration of Hospitalisation	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)	Duration of Hospitalisation was reported.
Real-World Overall Survival	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)	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.
Treatment Characteristics: Number of Participants Switching Between Different Platinum-Based Chemotherapies	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)	Number of participants switching between different platinum-based chemotherapies were reported.

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Participants With Locally Advanced or Metastatic Urothelial Cancer (UC) Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts.	106
Total	106

Arm

Count

Participants With Locally Advanced or Metastatic Urothelial Cancer (UC)

Participants with locally advanced or metastatic UC whose disease has not progressed following first line platinum-based chemotherapy and were treated with avelumab as a first line maintenance therapy were enrolled in this study. No intervention was administered and only clinical data collected in routine clinical care was accessed and analyzed as part of this noninterventional study. Data was extracted from patient medical records and hospital charts.

106

Total

106

Baseline characteristics

Characteristic	Participants With Locally Advanced or Metastatic Urothelial Cancer (UC)
Age, Continuous	65.5 years STANDARD_DEVIATION 12.33
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	106 Participants
Sex: Female, Male Female	28 Participants
Sex: Female, Male Male	78 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	66 / 106
other Total, other adverse events	78 / 106
serious Total, serious adverse events	34 / 106

Outcome results

Primary

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.

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)