Nivolumab and RT in Treating Patients With Localized/Locally Advanced Urothelial Bladder Cancer Ineligible for Chemo

PHASE2CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

April 24, 2018

Primary Completion Date

March 23, 2023

Study Completion Date

March 23, 2023

Conditions
Stage II Bladder Urothelial Carcinoma AJCC v6 and v7Stage III Bladder Urothelial Carcinoma AJCC v6 and v7Stage IV Bladder Urothelial Carcinoma AJCC v7
Interventions
DRUG

Nivolumab

Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.

RADIATION

Radiation

Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.

Trial Locations (2)

14263

Roswell Park Cancer Institute, Buffalo

48201

Barbara Ann Karmanos Cancer Institute, Detroit

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Barbara Ann Karmanos Cancer Institute

OTHER