OBSERVATIONAL STUDY OF AVELUMAB AS FIRST-LINE MAINTENANCE TREATMENT OF PATIENTS WITH ADVANCED UROTHELIAL CANCER AFTER CHEMOTHERAPY

• Sponsor: Pfizer (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05366725
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 22.3
• Patients Per Site Per Month: 4.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Urothelial Cancer	Drug: Avelumab

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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Other
• 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
• Actual Study Start Date: Jun 30, 2022
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: May 9, 2024

Arms and Interventions

Arm	Intervention/Treatment
Adult patients with locally advanced or metastatic urothelial cancer	Drug: Avelumab; As provided in real world practice

Outcome Measures

Primary Outcome Measures

1. Real world overall survival [September 2020 to April 2024]

   Time between avelumab initiation until date of death from any cause or end of follow-up

Secondary Outcome Measures

1. Real world progression free survival [September 2020 to April 2024]

   Time between avelumab initiation until earliest of: Date of first progression Date of death from any cause

2. Adverse events explicitly attributed to avelumab [September 2020 to April 2024]

   Any AE with explicit attribution to avelumab as noted in the clinical records. Explicit attribution is not inferred by a temporal relationship between drug administration and an AE butmust be based on a definite statement of causality by a healthcare provider linking drug administration to the AE. AE diagnosis Outcome of AE Classification as either serious or non-serious AE Results in hospitalisation or prolongation of hospitalisation Is life threatening Resulted in death Persistent or significant incapacity Congenital anomaly/birth defect in any offspring Other important medical event that may require medical or surgical intervention to avoid any of the above criteria AEs discontinuation of avelumab AEs leading to systemic steroid treatment

3. All-cause healthcare resource burden [September 2020 to April 2024]

   Mean and median number, per patient, of the following: Accident and emergency visits Hospitalisations Duration of hospitalisation (days)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beatson West of Scotland Cancer Centre	Glasgow		United Kingdom	G12 0YN

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05366725
• Other Study ID Numbers: B9991047
• First Posted: May 9, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Avelumab

Study Results

No Results Posted as of Aug 24, 2022