Phase II Study of sEphB4-HSA and Pembrolizumab for Treating Solid Tumors

Sponsor: University of Southern California

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02717156

Provider View

This clinical trial is testing a new combination of treatments, sEphB4-HSA and Pembrolizumab, to see if they are safe and effective for patients with certain types of solid tumors. The study includes four different groups of patients, each with specific cancer conditions.

Patient Parameters

Program Overview

This study is exploring a new treatment combination of a fusion protein called sEphB4-HSA and an anti-PD1 antibody called Pembrolizumab for patients with specific solid tumors. The trial is divided into four groups:

  1. Group A: Patients with advanced urothelial cancer who have not responded to platinum-based treatments.
  2. Group B: Patients with advanced urothelial cancer who have had at least two previous treatments, including one platinum-based.
  3. Group C: Patients with locally advanced bladder cancer receiving treatment before surgery.
  4. Group D: Patients with locally advanced prostate cancer receiving treatment before surgery.

Description

The main goals of this study are to understand the side effects of the combination treatment of sEphB4-HSA and Pembrolizumab in patients with solid tumors and to see how effective it is in different patient groups.

For patients with urothelial cancer (Groups A and B), the study will measure how long they live after treatment and how long they remain free of disease progression. For patients with bladder cancer (Group C), the study will look at how many patients have no signs of cancer in their tissue samples after treatment. For patients with prostate cancer (Group D), the study will measure the response of prostate-specific antigen (PSA) levels.

The study will also look at how the treatment affects the immune system and cancer cells by examining various markers and cells in the blood and tumor tissue. Patients will receive the treatment through an IV infusion every three weeks, as long as the cancer does not progress or side effects are manageable. After completing the treatment, patients will have follow-up visits to monitor their health and the treatment's effects.

Eligibility Criteria

Exclusion Criteria

  • Currently participating in another study or have used an investigational treatment within 4 weeks before starting this trial.
  • Have an immune system deficiency or are taking medications that suppress the immune system within 7 days before starting the trial.
  • Have a history of active tuberculosis (TB).
  • Allergic to Pembrolizumab or its ingredients.
  • Have had a monoclonal antibody treatment within 4 weeks before the trial or have not recovered from side effects of previous treatments.
  • Have had chemotherapy, targeted therapy, or radiation within 2 weeks before the trial or have not recovered from side effects, except for mild neuropathy.
  • Have another progressing cancer that needs treatment, except for certain skin cancers or cervical cancer.
  • Have active cancer spread to the brain or spinal cord, unless treated and stable.
  • Have an active autoimmune disease needing treatment in the past 2 years.
  • Have a history of lung inflammation not caused by infection.
  • Have psychiatric or substance abuse issues affecting trial participation.
  • Are pregnant, breastfeeding, or planning to conceive during the trial and for 120 days after.
  • Have had previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 agents, or sEphB4-HSA.
  • Have HIV, active Hepatitis B or C.
  • Have severe heart conditions or other medical issues that make the trial unsafe.
  • Have received a live vaccine within 30 days before starting the trial.
  • Have uncontrolled high blood pressure.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.