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Protocol Summary


Protocol No.
PSCI-18-014
Prinicipal Investigator
Drabick, Joseph
Phase
Phase I/II
Age Group
Adult
Scope
National
Secondary Protocol No.
I 53217
Title
A Phase Ib/11 Study of Propranolol with fixed-dose Pembrolizumab in Patients with Unresectable Stage III and Stage IV Melanoma
Objective
Primary Objectives
1. To determine dose limiting toxicities (DLT) of propranolol in combination with fixed dose pembrolizumab in the treatment of melanoma.
2. To evaluate the efficacy of pembrolizumab in combination with propranolol in patients with melanoma, as determined by overall response rate (ORR) per immune-related RECIST v1.1 (irRECIST v1.1)

Secondary Objectives
1. To evaluate the efficacy of pembrolizumab in combination with propranolol in patients with melanoma, as determined by secondary measures of efficacy, including: Progression free survival (PFS); Overall Survival.

Exploratory Objectives
1. To correlate baseline or changes in the levels of biomarkers, like, peripheral T-cell subsets/myeloid derived suppressor cells (MDSC)/cytokines/ and perceived stress scale (PSS) with efficacy (ORR, PFS, OS) in melanoma patients treated with pembrolizumab and propranolol.
Applicable Disease Sites
Melanoma, Skin
Status
Open
Participating Institutions
Hershey Medical Center