A Phase II trial of sEphB4-HSA in combination with Anti PD1 Antibody Pembrolizumab (MK-3475) for metastatic urothelial cancer refractory to platinum


Patients with the most common type of bladder cancer are initially treated with chemotherapy with regimens that include a platinum agent such as cisplatin or carboplatin. Once the cancer develops resistance the treatment is changed to an anti PD1/PDL1 immunotherapy with drugs such as pembrolizumab or nivolumab. This study proposes to give pembrolizumab to patients who have had further growth of their cancer after chemotherapy with a platinum agent, according to standard of care, and combine it with an experimental agent, sEphB4-HSA, which may have synergistic effect with pembrolizumab. It is hypothesized that the two drugs, in combination, will be more effective than either drug alone. The sEphB4-HSA was studied in various cancers and was found to be safe with its primary side effect being elevated blood pressure which may require blood pressure medication while receiving the drug. If you, or a loved one, has advanced (metastatic, stage IV, or unresectable) bladder cancer (or urothelial carcinoma) and have been treated with platinum-based chemotherapy in the past, this trial may be a treatment option

Palabras clave: Metastatic bladder cancer, metastatic urothelial carcinoma, immunotherapy

Sitios de estudio

University of Southern California, Norris Comprehensive Cancer Center 90089

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  • Men & Women
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¿Qué hay involucrado?

Duración del ensayo
  • Treatment will continue as long as treatment side effects are manageable and patients are benefiting from the treatment.

Número de visitas
  • Screening visits and weekly infusions.

  • Patients will be monitored closely for side effects.

  • A biopsy prior to enrollment is required and a second optional biopsy after cycle 2 of treatment

  • There are no financial compensations offered on this study.

Cobertura de gastos médicos
  • All research tests and procedures provided to you for this study are being paid for by the trial. Neither you and/or your health plan/insurance company will be charged for the cost of any research tests or procedures that are being done for this study; however you will be responsible for any co-payments and deductibles that are standard for your health plan/insurance coverage.

  • The study drugs will be provided by MERCK and VasGene Therapeutics, Inc., free of charge while you are participating in this research study. Additional information will be provided and all questions will be answered prior to enrollment.

Why participate?

If you have previously been treated with immunotherapy for advanced urothelial carcinoma and your cancer is not responding to treatment, this study may offer a treatment option. You and your physician may discuss the suitability of this study and determine whether you should pursue this as an option.


Criterios de inclusión

  • Adult men and women who have been diagnosed with metastatic urothelial carcinoma who have received platinum based chemotherapy, previously.

Criterios de exclusión

  • Other cancers actively under treatment or rheumatologic disorders such as rheumatoid arthritis and lupus.

Study Sites

  • University of Southern California, Norris Comprehensive Cancer Center
  • University of Southern California, Los Angeles County Hospital
  • City of Hope

Equipo del Programa

Investigador Principal
Sarmad Sadeghi, MD, PhD

For questions about this study, contact:

  • Clinical Research Nurse Coordinator Cheryl Kefauver, RN, CCRP
  • USC/Norris Comprehensive Cancer Center Clinical Investigations Support Office
  • 323-865-0845
  • Cheryl.Kefauver@med.usc.edu
  • Multi-Site Coordinator Grace Kim
  • USC/Norris Comprehensive Cancer Center Clinical Investigations Support Office
  • 323-865-3122
  • Grace.Kim@med.usc.edu

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