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.
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).
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.
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
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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