Immune Checkpoint Inhibitors with or without Propranolol Hydrochloride for the Treatment of Urothelial Cancer

Active:	Yes
Cancer Type:	Unknown Primary	NCT ID:	NCT04848519
Trial Phases:	Phase II	Protocol IDs:	WINSHIP5200-20 (primary) NCI-2021-00437
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04848519

Summary

This clinical trial studies the effect of propranolol hydrochloride with or without immune checkpoint inhibitors (pembrolizumab, nivolumab, or avelumab) in treating patients with urothelial cancer. Propranolol hydrochloride is used for the treatment of chronic angina, cardiac arrhythmias, essential tremor, and hypertension, and as prophylaxis for migraine headaches, and may have anticancer properties. Immunotherapy with monoclonal antibodies, such as pembrolizumab, nivolumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Objectives

PRIMARY OBJECTIVE:
I. To safety as measured by incidence of adverse events assessed for immune checkpoint inhibitors (ICI) plus propranolol versus ICI alone in patients with urothelial cancer.

SECONDARY OBJECTIVES:
I. To describe response to ICI plus or minus propranolol in metastatic urothelial cancer.
II. To assess tissue-based assays in archival tissue and correlative changes in peripheral T-cell subsets, myeloid
derived suppressor cells (MDSC), blood inflammatory markers and cytokines.

OUTLINE: Patients are assigned to 1 of 2 arms.

ARM I: Patients receive propranolol hydrochloride orally (PO) on study, and receive ICI intravenously (IV) as clinically indicated. Patients undergo computed tomography (CT) scan, magnetic resonance imaging (MRI), and blood sample collection throughout the study.

ARM II: Patients receive ICIs IV as clinically indicated. Patients undergo CT scan, MRI and blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 2 years for survival.

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