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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

OU-SCC-ABC Trial Summary

This trial is testing the safety of combining avelumab with BCG to treat bladder cancer.

Eligible Conditions

Bladder Cancer

OU-SCC-ABC Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Percent of Patients With Complete Response

Percent of Patients With Recurrence Free Survival

Proportion of Patients Receiving Complete Induction Course

+3 more

Side effects data

From undefined Phase 2 trial • 149 Patients • NCT02062580

13%

Rash- nonspecific

13%

Cough

10%

Diaper Rash

Fever

Blocked nostrils

HIV infection

100%

80%

60%

40%

20%

Study treatment Arm

Delayed BCG

Early BCG

OU-SCC-ABC 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

2018

Completed Phase 2

~2450

BCG

2015

Completed Phase 4

~3220

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

97,592 Total Patients Enrolled

EMD SeronoIndustry Sponsor

143 Previous Clinical Trials

27,183 Total Patients Enrolled

Kelly Stratton, MDPrincipal InvestigatorStephenson Cancer Center

1 Previous Clinical Trials

12 Total Patients Enrolled

Frequently Asked Questions

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

Is this experiment accepting new members?

"Information accessible on clinicaltrials.gov reveals that this particular trial, which debuted May 1st 2019 and was last modified November 21st 2022 is no longer recruiting patients; however, there are 485 other ongoing studies in need of participants."

Answered by AI

How many individuals can take part in this clinical investigation?

"At the moment, this trial is not accepting any new candidates. First posted on May 1st 2019 and last updated November 21 2022, this study has concluded recruitment. However, there are 373 clinical trials presently recruiting people with bladder cancer or carcinoma and 112 studies that accept patients undergoing BCG therapy."

Answered by AI

Has the BCG vaccine been studied previously?

"Presently, there are 112 active clinical trials researching the effects of BCG. Of these experiments, 10 have advanced to Phase 3 testing. Although investigations on this treatment began in Barcelona and South dakota, currently over three thousand six hundred eighty five locations offer it as a study option."

Answered by AI

Does this clinical experimentation represent an innovative approach?

"Since its debut in 2014, BCG has been the subject of numerous clinical trials. Its initial trial was sponsored by EMD Serono Research & Development Institute and involved 204 participants. This led to Phase 2 approval for BCG and now there are 112 active studies across 1024 cities in 52 countries around the world."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer

2019. "Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03892642.