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Avelumab for Bladder Cancer

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 60 months
Awards & highlights

Study Summary

This trial will compare the effects of avelumab plus best supportive care versus best supportive care alone on survival in patients with locally advanced or metastatic urothelial cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) - Visual Analog Scale (VAS) Score at Cycle 6
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Overall Health Utility Score at Cycle 6
Change From Baseline in National Comprehensive Cancer Network- Functional Assessment of Cancer Therapy (NCCN-FACT) Bladder Symptom Index- 18 (FBlSI-18) Score at Day 1 of Cycle 6
+22 more

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
Investigations
6%
Cardiac disorders
6%
Infections and infestations
6%
Endocrine disorders
6%
Nervous system disorders
6%
Gastrointestinal disorders
6%
General disorders and administration site conditions
6%
Metabolism and nutrition disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm BExperimental Treatment2 Interventions
Best Supportive Care (BSC) alone Following the planned interim analysis for this study, eligible patients in Arm B whose cancer has not worsened and are still in the "watch and wait" part of the study will be given the option to receive Avelumab plus BSC. Prior to this, Arm B patients received BSC alone. All patients who choose not to receive Avelumab will be discontinued.
Group II: Arm AExperimental Treatment2 Interventions
Avelumab plus Best Supportive Care (BSC)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Following the planned interim analysis for this study: Avelumab
2016
Completed Phase 3
~700
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,571 Previous Clinical Trials
10,922,589 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,477 Previous Clinical Trials
8,098,807 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have similar tests been run before?

"Currently, there are 116 global clinical trials underway for Avelumab in over 1000 cities across 52 countries. The first trial began in 2014 and was sponsored by EMD Serono Research & Development Institute, Inc. That initial study involved 204 patients and completed Phase 2 drug approval. To date, 70 total trials have been completed since 2014."

Answered by AI

What is the general efficacy of Avelumab in past studies?

"Port Macquarie Base Hospital was the first medical institution to study avelumab in 2014. Since then, there have been 70 completed studies with 116 more presently ongoing. Many of these active trials are being conducted out of Aurora, Colorado."

Answered by AI

How many individuals are being welcomed into this research project?

"Unfortunately, this trial is not currently open for recruitment. The listing was created on April 25th, 2016 and last updated on October 24th, 2022. However, there are other trials that may be of interest. There are 32 urothelial cancer studies and 116 Avelumab trials that are still seeking participants."

Answered by AI

What are some of the dangers patients face when taking Avelumab?

"Avelumab is classified as a 3 on our Power team's safety scale. This is due to the fact that it has reached Phase 3 in clinical trials, meaning that there is both anecdotal and empirical evidence supporting its efficacy and safety."

Answered by AI

Are there many different places in America where this clinical trial is taking place?

"There are a total of 19 locations running this clinical trial, some of which include University of Colorado Denver, CTO (CTRC) in Aurora, University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP) in New Haven, and Smilow Cancer Hospital at Yale-New Haven in Seattle."

Answered by AI
Recent research and studies
~78 spots leftby May 2025