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Monoclonal Antibodies

BCG for 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Patients Receiving Complete Induction Course

Secondary study objectives

Percent of Patients With Complete Response

Percent of Patients With Recurrence Free Survival

Proportion of Patients With Complete Response

+2 more

Side effects data

From undefined Phase 2 trial • 149 Patients • NCT02062580

13%

Cough

13%

Rash- nonspecific

10%

Diaper Rash

Fever

Blocked nostrils

HIV infection

100%

80%

60%

40%

20%

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