A Phase 2 Trial of Pembrolizumab Plus Bevacizumab in Patients with Metastatic Melanoma or Non-small Cell Lung Cancer with Untreated Brain Metastases
The purpose of this study is to explore whether or not pembrolizumab combined with bevacizumab has beneficial effects and is safe for use in participants diagnosed with metastatic melanoma or non-small cell lung cancer (NSCLC) who also have untreated brain metastases. Investigators will also study the effects of this combination on tumors outside of the brain (when present) and on survival.
Primary Objectives/Endpoints: 1. To determine the brain metastasis response rate in patients with melanoma or NSCLC with untreated brain metastases, treated systemically with pembrolizumab plus bevacizumab. Secondary Objectives/Endpoints: 1. To determine the incidence of steroid use for control of cerebral edema during treatment with pembrolizumab plus bevacizumab in patients with metastatic melanoma or NSCLC to the brain compared to previous study of patients treated with pembrolizumab alone. 2. To determine the best overall response rate (ORR) in patients with brain metastases from melanoma or NSCLC treated with combination pembrolizumab plus bevacizumab. 3. To evaluate median progression free survival (PFS) and overall survival (OS) in patients with melanoma or NSCLC metastatic to the brain, treated with pembrolizumab plus bevacizumab. 4. To determine the safety of pembrolizumab in combination with bevacizumab in patients with untreated brain metastases from melanoma or NSCLC. Exploratory Objective: To study PD-L1 expression and other potential predictive biomarkers in CNS, tumors and blood, and correlate results with response to pembrolizumab plus bevacizumab.
Avastin (Bevacizumab); Bevacizumab (); Pembrolizumab (Keytruda)
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