NCT03049618

Recombinant EphB4-HSA Fusion Protein and Pembrolizumab, MK-3475

A Phase IIa Trial of sEphB4-HSA in Combination With Anti PD-1 Antibody (Pembrolizumab, MK3475) in Patients With Non-small Cell Lung and Head/Neck Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase IIa trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab work in treating patients with non-small cell lung cancer that has spread to other places in the body or head and neck squamous cell cancer that has come back or spread to other places in the body. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Giving recombinant EphB4-HSA fusion protein and pembrolizumab may work better in treating patients with non-small cell lung or head and neck squamous cell cancer.

Detailed description

PRIMARY OBJECTIVES: I. Determine the response rate of the combination of pembrolizumab and recombinant EphB4-HSA fusion protein (sEphB4-HSA) as combination therapy. SECONDARY OBJECTIVES: I. Determine the biomarkers of response. II. Determine the unique toxicities of the combination of pembrolizumab and sEphB4-HSA. OUTLINE: Patients receive pembrolizumab intravenously (IV) over 30 minutes on day 1 and recombinant EphB4-HSA fusion protein IV over 30 minutes on days 1, 8, and 15. Courses repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks.

Conditions

• ALK Gene Mutation
• BRAF Gene Mutation
• EGFR Gene Mutation
• Head and Neck Squamous Cell Carcinoma
• Metastatic Head and Neck Carcinoma
• Recurrent Head and Neck Carcinoma
• Recurrent Non-Small Cell Lung Carcinoma
• ROS1 Gene Mutation
• Stage III Non-Small Cell Lung Cancer
• Stage IIIA Non-Small Cell Lung Cancer
• Stage IIIB Non-Small Cell Lung Cancer
• Stage IV Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
OTHER	Laboratory Biomarker Analysis	Correlative studies
BIOLOGICAL	Pembrolizumab	Given IV
BIOLOGICAL	Recombinant EphB4-HSA Fusion Protein	Given IV

Timeline

• Start date: 2017-03-10
• Primary completion: 2024-09-04
• Completion: 2024-09-04
• First posted: 2017-02-10
• Last updated: 2025-10-22
• Results posted: 2025-10-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study