NCT04848519View on ClinicalTrials.gov

Immune Checkpoint Inhibitors With or Without Propranolol Hydrochloride In Patients With Urothelial Carcinoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

May 20, 2021

Primary Completion Date

January 1, 2026

Study Completion Date

January 1, 2027

Conditions
Locally Advanced Bladder Urothelial CarcinomaLocally Advanced Renal Pelvis Urothelial CarcinomaLocally Advanced Ureter Urothelial CarcinomaLocally Advanced Urethral Urothelial CarcinomaLocally Advanced Urothelial CarcinomaMetastatic Bladder Urothelial CarcinomaMetastatic Renal Pelvis Urothelial CarcinomaMetastatic Ureter Urothelial CarcinomaMetastatic Urethral Urothelial CarcinomaMetastatic Urothelial CarcinomaStage IV Bladder Cancer AJCC v8Stage IV Renal Pelvis Cancer AJCC v8Stage IV Ureter Cancer AJCC v8Stage IV Urethral Cancer AJCC v8
Interventions
DRUG

Pembrolizumab

Given IV as first line for locally advanced or metastatic urothelial carcinoma who are not eligible for platinum-based chemotherapy; or second line for locally advanced or metastatic urothelial carcinoma after progression on platinum-based chemotherapy

DRUG

Propranolol Hydrochloride

Given PO for patients on the ICI plus propranolol arm

DRUG

Nivolumab

Given IV as adjuvant treatment of urothelial carcinoma in high risk of disease recurrence after undergoing radical resection

DRUG

Avelumab

Given IV as maintenance treatment in locally advanced or metastatic urothelial carcinoma following no progression on first-line platinum-containing chemotherapy

Trial Locations (1)

30322

RECRUITING

Emory University Hospital/Winship Cancer Institute, Atlanta

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Emory University

OTHER