A Phase II Trial of Pembrolizumab Plus Bevacizumab in Patients With Metastatic Melanoma or Non-small Cell Lung Cancer With Untreated Brain Metastases

What is the purpose of this trial?

The purpose of this phase 2 trial is to study the activity of pembrolizumab in combination with bevacizumab in patients with untreated brain metastases from melanoma or NSCLC to determine activity and safety of the drug combination. Furthermore, in patients who undergo resection of biopsy of a brain metastasis, we will evaluate biomarkers predictive of treatment benefit, and will also conduct correlative biomarker studies on extra-cerebral specimens in all patients in whom a systemic biopsy is feasible or in archival tumor tissue when available.

A total of 53 eligible patients will be enrolled on this trial (20 with melanoma and 33 with NSCLC). Individual cohorts of the study can be stopped if insufficient activity is observed in the first stage of that cohort. The study will accrue for approximately 24 months, and will be open for approximately 12 additional months as patients on study are being followed.

Participation Guidelines

Ages: 18 years and older

Gender: Both

Yale Cancer Center

Start Date: 05/27/2016

End Date: 05/01/2019

Last Updated: 06/22/2018

Study HIC#: 1512016953