Propranolol Hydrochloride and Pembrolizumab for the Treatment of Recurrent or Metastatic Urothelial Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. To evaluate the anti-tumor activity of the combination of propranolol hydrochloride and pembrolizumab by assessing the overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). SECONDARY OBJECTIVE: I. To evaluate the efficacy of the ...

PRIMARY OBJECTIVE: I. To evaluate the anti-tumor activity of the combination of propranolol hydrochloride and pembrolizumab by assessing the overall response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1.). SECONDARY OBJECTIVE: I. To evaluate the efficacy of the combination as measured by progression free survival (PFS; from treatment initiation until disease progression, death due to disease, or lost to follow up) and overall survival (OS; from treatment initiation until death due to any cause or loss to follow up), and safety as measured by incidence of adverse events assessed up to 2 years. TERTIARY/EXPLORATORY OBJECTIVE: I. 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 receive propranolol hydrochloride orally (PO) twice daily (BID) on days 1-21 and pembrolizumab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days for propranolol hydrochloride and every 3 or 6 weeks for pembrolizumab for up to 2 years in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for up to 2 years.

Tracking Information