CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Avelumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03892642
NCT03892642Phase 2Completed
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Phase Ib Study of Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer (ABC Trial)

University of Oklahoma·interventional·Posted Mar 27, 2019·Updated Feb 14, 2024

In Brief

A Phase 2 clinical trial evaluating Avelumab and BCG for Bladder Cancer. Completed, enrolled 18 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsEMD Serono

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedMar 27, 2019
Enrollment StartMay 1, 2019
Primary CompletionMar 23, 2021
Study CompletionAug 13, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.3 years ago

Interventions

Avelumabdrug

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

BCGbiological

Induction phase (cycle 1): • Once weekly for weeks 1-6 Maintenance phase (Month 3, 6, and 12): • Once weekly for 3 weeks