Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

Avelumab

BCG Vaccine

Antineoplastic Agents, Immunological

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.

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

Induction phase (cycle 1):

• Once weekly for weeks 1-6

Maintenance phase (Month 3, 6, and 12):

• Once weekly for 3 weeks

Kelly Stratton, MD

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.

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.

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)

Proportion of patients receiving complete induction course, defined as freedom from DLT preventing completion of at least 5 of 6 treatments of BCG + avelumab

completion of at least 2 of 3 treatments within each 5 week period

based on negative cystoscopy and urine cytology. A negative biopsy at 6 months will provide evidence of complete response.

defined as percent of patients who are alive and free of persistent or recurrent NMIBC based on cystoscopy, cytology and/or biopsy.

defined as proportion of patients who are alive and free of persistent or recurrent NMIBC based on cystoscopy, cytology and/or biopsy

defined by time from day of first treatment to first progression to higher grade or stage, including muscle-invasive disease or death from any cause

EMD Serono

University of Oklahoma

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.

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

BCG: Induction phase (cycle 1):

• Once weekly for weeks 1-6

Maintenance phase (Month 3, 6, and 12):

• Once weekly for 3 weeks

BCG + Avelumab

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Associate Professor

Proportion of Patients Receiving Complete Induction Course

Patients who remained on study for induction course

Percent of Patients With Complete Response

Proportion of Patients With Complete Response

Patients who experienced complete response

Percent of Patients With Recurrence Free Survival

Proportion of Patients With Recurrence Free Survival

Patients who experienced progression or death or who stayed on study for at least 6 months

Proportion of Patients With Progression-free Survival

Patients who experienced progression or death or who remained at study at least 12 months

Spots Global Cancer Trial Database for Avelumab Plus Bacille Calmette-Guerin (BCG) in Patients With Non-muscle Invasive Bladder Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial