drugset / Trial / NCT02717156

Multicohort Phase II Trial of sEphB4-HSA+Pembrolizumab in Solid Tumors

NCT02717156

NaSingle-groupOpen-labelTreatment

Summary

This is a multi-cohort single arm phase II/screening trial of the combination of a fusion protein that binds EphrinB2 and blocks interaction with cell surface EphB receptors (sEphB4-HSA) in combination with an anti-PD1 antibody (MK-7435 / Pembrolizumab) for treatment of patients with specific solid tumors. There will be four cohorts in this trial: 1. Cohort A, phase II 2nd line trial of sEphB4-HSA and pembrolizumab for platinum refractory metastatic urothelial carcinoma. 2. Cohort B, phase II 3rd line trial of sEphB4-HSA and pembrolizumab for platinum refractory metastatic urothelial carcinoma. 3. Cohort C, phase II neoadjuvant trial of sEphB4-HSA and pembrolizumab for locally advanced muscle invasive urothelial carcinoma. 4. Cohort D, phase II neoadjuvant trial of sEphB4-HSA and pembrolizumab for locally advanced prostate cancer.

Timeline

Start
2016-11-21
Primary completion
2027-12-31
Completion
2030-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody Intravenous
Subject sEphB4-HSA Protein / enzyme biologic Intravenous