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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04848519
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Locally Advanced Bladder Urothelial Carcinoma
  • Locally Advanced Renal Pelvis Urothelial Carcinoma
  • Locally Advanced Ureter Urothelial Carcinoma
  • Locally Advanced Urethral Urothelial Carcinoma
  • Locally Advanced Urothelial Carcinoma
  • Metastatic Bladder Urothelial Carcinoma
  • Metastatic Renal Pelvis Urothelial Carcinoma
  • Metastatic Ureter Urothelial Carcinoma
  • Metastatic Urethral Urothelial Carcinoma
  • Metastatic Urothelial Carcinoma
  • Stage IV Bladder Cancer AJCC v8
  • Stage IV Renal Pelvis Cancer AJCC v8
  • Stage IV Ureter Cancer AJCC v8
  • Stage IV Urethral Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    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
  • Propranolol Hydrochloride — DRUG
    Given PO for patients on the ICI plus propranolol arm
  • Nivolumab — DRUG
    Given IV as adjuvant treatment of urothelial carcinoma in high risk of disease recurrence after undergoing radical resection
  • Avelumab — DRUG
    Given IV as maintenance treatment in locally advanced or metastatic urothelial carcinoma following no progression on first-line platinum-containing chemotherapy

Study Details

This research study is an open label study designed to evaluate the safety and translational correlative changes of the combination of propranolol hydrochloride and immune checkpoint inhibitors (ICI) in subjects with urothelial carcinoma.

Key Dates

Start date
May 20, 2021
Status verified
Feb 2026
Primary completion
Oct 15, 2025
Completion
Dec 4, 2026

Study Design

Enrollment
6 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (propranolol hydrochloride, immune checkpoint inhibitor)
    The specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval.
  • Other: Treatment (immune checkpoint inhibitor)
    The specific ICI that the subject would receive will be dependent on the clinical need and associated FDA approval.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322-

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Emory University Hospital/Winship Cancer Institute· Atlanta, GA

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