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Monoclonal Antibodies
Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer (OU-SCC-ABC Trial)
Phase 1 & 2
Waitlist Available
Led By Kelly Stratton, MD
Research Sponsored by University of Oklahoma
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 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combination of avelumab and BCG in patients with recurrent bladder cancer. The treatment aims to boost the immune system to help it find and destroy cancer cells. Avelumab is a type of medication that has been studied for its effects on bladder cancer.
Eligible Conditions
- Bladder Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Percent of Patients With Complete Response
Percent of Patients With Recurrence Free Survival
Proportion of Patients Receiving Complete Induction Course
+3 moreSide effects data
From undefined Phase 2 trial • 149 Patients • NCT0206258013%
Cough
13%
Rash- nonspecific
10%
Diaper Rash
8%
Fever
6%
Blocked nostrils
3%
HIV infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Delayed BCG
Early BCG
Awards & Highlights
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: BCG + AvelumabExperimental Treatment2 Interventions
Combination of avelumab and intravesical BCG. One cycle = 12 weeks (84 days). A standard maintenance therapy regimen will be provided with BCG occurring at Month 3, 6, and 12. Avelumab treatment ends at the conclusion of Month 12 maintenance therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2017
Completed Phase 2
~2440
BCG
2015
Completed Phase 4
~3220
Find a Location
Who is running the clinical trial?
University of OklahomaLead Sponsor
474 Previous Clinical Trials
93,673 Total Patients Enrolled
EMD SeronoIndustry Sponsor
145 Previous Clinical Trials
27,761 Total Patients Enrolled
Kelly Stratton, MDPrincipal InvestigatorStephenson Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled