Clinical Trials Search
Clinical Trial 18136
Cancer Type: Sarcoma
Study Type: Treatment
Phase of Study: Phase II
- Damon Reed (MD)
SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients with Advanced Sarcomas
The purpose of this study is to learn if this treatment useful in patients with advanced soft tissue and bone sarcomas.
Primary Objective: 1. To determine the efficacy of pembrolizumab (MK-3475, SCH 900475) in patients with advanced sarcomas as measured by Objective Response Rate (ORR) using RECIST 1.1. Secondary Objectives: 1. To determine the safety and tolerability of pembrolizumab in this patient population. 2. To determine the Progression-Free Survival (PFS) by RECIST 1.1 and Overall Survival (OS) in this patient population. 3. To determine the response rate as measured by the immune-related Response Criteria (ir-RC). Exploratory Objectives: 1. To determine the effect of pre-treatment PD-L1 expression levels on response rates and the role of PD-L1 expression as a predictive biomarker for clinical benefit. 2. To determine the association of circulating regulatory T cells (Tregs) and Myeloid- Derived Suppressor Cells (MDSCs) at baseline and their changes while on therapy with clinical benefit. 3. To perform immune monitoring in the circulation and in the tumor microenvironment while on therapy with pembrolizumab - specifically, the frequency of circulating T cell populations, including NY-ESO-1 specific cytotoxic T cells, as well as T cell infiltration in available pre- and post- therapy tumor tissues will be assessed.