NCT02681549

Pembrolizumab Plus Bevacizumab for Treatment of Brain Metastases in Metastatic Melanoma or Non-small Cell Lung Cancer (NSCLC)

A Phase 2 Trial of Pembrolizumab Plus Bevacizumab in Patients With Metastatic Melanoma or Non-small Cell Lung Cancer With Untreated Brain Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 (40 with melanoma and 13 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 84 months, and will be open for approximately 12 additional months as patients on study are being followed.

Conditions

• Melanoma
• Non-small Cell Lung Cancer
• Brain Metastasis

Interventions

Type	Name	Description
DRUG	Pembrolizumab plus Bevacizumab	Pembrolizumab will be administered on day 1 of every cycle until disease progression or withdrawal from study. Bevacizumab will be administered in addition to pembrolizumab on day 1 of cycles 1, 2, 3, and 4 (or alternative cycles if bevacizumab is held during these cycles). Three weeks constitutes one cycle.

Timeline

• Start date: 2016-05-01
• Primary completion: 2024-09-11
• Completion: 2025-03-31
• First posted: 2016-02-12
• Last updated: 2025-08-07
• Results posted: 2025-08-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study