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

NCT03892642 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-14

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • EMD Serono

    collaborator INDUSTRY

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Kelly Stratton, MD · Stephenson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2021-03-23
Completion
2023-08-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892642 on ClinicalTrials.gov