NCT03892642

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

Phase Ib Study of Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer (ABC Trial)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety of avelumab and Bacille Calmette-Guerin (BCG) and see what effects (good and bad) that this combination treatment has on subjects with recurrent bladder cancer.

Detailed description

There will be exams, tests and procedures to see if the patient is eligible for the study. Some are part of regular cancer care and others are part of the study. Subjects will also need to complete a research questionnaire at certain points in the study. Subjects will receive treatment of avelumab and intravesical BCG until unacceptable toxicity or tumor progression. Study participation is up to three years.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Avelumab	Induction phase: * once weekly for weeks 1-6, * once every 2 weeks at week 8, 10, and 12 Maintenance phase: * Once every week for weeks 1-3 * Once every 2 weeks starting at week 5, until the next BCG treatment
BIOLOGICAL	BCG	Induction phase (cycle 1): • Once weekly for weeks 1-6 Maintenance phase (Month 3, 6, and 12): • Once weekly for 3 weeks

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-03-23
• Completion: 2023-08-13
• First posted: 2019-03-27
• Last updated: 2024-02-14
• Results posted: 2022-04-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study