NCT03518320 - Safety and Tolerability of TAR-200 and Nivolumab in Subjects With Muscle-Invasive Bladder Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 2, 2019

Primary Completion Date

December 11, 2019

Study Completion Date

December 11, 2019

Conditions

Bladder Cancer TNM Staging Primary Tumor (T) T2Bladder Cancer TNM Staging Primary Tumor (T) T2ABladder Cancer TNM Staging Primary Tumor (T) T2BBladder Cancer TNM Staging Primary Tumor (T) T3Bladder Cancer TNM Staging Primary Tumor (T) T3ABladder Cancer TNM Staging Primary Tumor (T) T3BBladder Cancer TNM Staging Regional Lymph Node (N) N0Bladder Cancer TNM Staging Regional Lymph Node (N) N1Bladder Cancer TNM Staging Distant Metastasis (M) M0

Interventions

DRUG

Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200

TAR-200 will be placed in the bladder through an inserter and gradually release gemcitabine for four consecutive 21-day dosing cycles for a total period of approximately 84 days

DRUG

Nivolumab Injection [Opdivo]

Nivolumab will be given intravenously on specified days for four consecutive 21-day dosing cycles for a total period of approximately 84 days

Trial Locations (6)

14642

University of Rochester Medical Center, Rochester

19107

Thomas Jefferson University, Philadelphia

27710

Duke University Medical Center, Durham

37232

Vanderbilt University Medical Center, Nashville

60521

DuPage Medical Group, Hinsdale

73104

The University of Oklahoma Stephenson Cancer Center, Oklahoma City