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Recombinant EphB4-HSA Fusion Protein and Pembrolizumab in Treating Patients With Metastatic or Recurrent Urothelial Cancer That Is Refractory to Certain Chemotherapy Drugs

2016-03-24 07:23:23 | BioPortfolio

Summary

This phase II trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab work in treating patients with urothelial (bladder) cancer that has spread from the primary site to other places in the body or has come back and does not respond to certain chemotherapy drugs. Combinations of biological substances in recombinant EphB4-HSA fusion protein may be able to carry tumor-killing substances directly to urothelial cancer cells. 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 together may be a better treatment for patients with urothelial cancer.

Description

PRIMARY OBJECTIVES:

I. To determine the feasibility of using pembrolizumab-recombinant EphB4-HSA fusion protein (sEphB4-HSA) combination in patients with advanced urothelial carcinoma.

II. To measure the overall survival (OS).

SECONDARY OBJECTIVES:

I. To measure the progression-free survival (PFS). II. To measure the objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

TERTIARY OBJECTIVES:

I. To examine programmed cell death 1 (PD-1), programmed cell death 1 ligand 1 (PD-L1), programmed cell death 1 ligand 2 (PD-L2) and EPH receptor B4 (EphB4) expression by tumor cells (TC) as well as immune cells (IC)- macrophages and T cells- in tumor tissue and correlate them with ORR, PFS and OS.

II. To examine the tumor tissue T cell frequency (counts), tumor tissue T cell clonality using T cell receptor (TCR) sequencing, and peripheral blood T cell clonality, pre-treatment and post-treatment and correlate these with ORR, PFS and OS.

III. To measure the phenotype of lymphocytes and myeloid derived suppressor cells (MDSC), in pre and post-treatment blood samples and correlate these with ORR, PFS and OS; an extra blood sample for future studies will also be collected and banked.

IV. To examine peripheral blood circulating tumor cells (CTCs) for enumeration and molecular analysis in pre and post-treatment blood samples, and correlate these with ORR, PFS and OS.

V. To collect and bank tumor tissue. VI. To examine the role of adding positron emission tomography (PET) to a contrast computed tomography (CT) for evaluation of response to treatment.

OUTLINE:

Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes on days 1, 8, and 15 and pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days and then every 6-12 weeks.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Stage IV Bladder Urothelial Carcinoma

Intervention

Computed Tomography, Laboratory Biomarker Analysis, Pembrolizumab, Positron Emission Tomography, Recombinant EphB4-HSA Fusion Protein

Location

USC / Norris Comprehensive Cancer Center
Los Angeles
California
United States
90033

Status

Not yet recruiting

Source

University of Southern California

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-03-24T07:23:23-0400

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