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Monoclonal Antibodies

Avelumab for Bladder Cancer

Phase 1 & 2
Waitlist Available
Led By Jennifer M. Taylor, MD
Research Sponsored by Baylor College of Medicine
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 2 years after radical cystectomy
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This is a pilot study of avelumab in patients with non-metastatic, muscle invasive bladder cancer who are eligible for radical cystectomy (RC), but are ineligible for cisplatin based neoadjuvant therapy. The target recruitment is 10 evaluable patients for this window of opportunity study. Pre- and post-treatment tumor samples from transurethral resection of the bladder tumor and RC will be used for study endpoints.

Eligible Conditions
  • Bladder Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after radical cystectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after radical cystectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in T Cell Subpopulations
Secondary study objectives
2 Year Disease Free Survival (DFS)
Pathological Response Rate
Rate of High Grade(Grade 3-4) Adverse Event

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848
17%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Endocrine disorders
6%
General disorders and administration site conditions
6%
Metabolism and nutrition disorders
6%
Nervous system disorders
6%
Investigations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Infections and infestations
6%
Immune system 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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AvelumabExperimental Treatment1 Intervention
Avelumab 10 mg/kg intravenously, over 60 minutes every 2 weeks for 3 cycles or 42 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
FDA approved

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,024 Previous Clinical Trials
6,029,533 Total Patients Enrolled
PfizerIndustry Sponsor
4,658 Previous Clinical Trials
17,877,424 Total Patients Enrolled
Jennifer M. Taylor, MDPrincipal InvestigatorBaylor College of Medicine
~0 spots leftby Nov 2025
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