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Monoclonal Antibodies

sEphB4-HSA + Pembrolizumab for Cancer

Phase 2

Recruiting

Led By Sarmad Sadeghi, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Criteria specific to the neoadjuvant urothelial cohort (Cohort C): Must have tumor stage ≥T2 AND ≤T4a, N0, M0 (AJCC 8th edition) urothelial carcinoma of the bladder deemed resectable and planned for radical cystectomy with curative intent. T4 due to infiltration of the prostate is allowed.

Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 X ULN or =< 5 X ULN for subjects with liver metastases

Must not have

Has a known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses a fusion protein and an anti-PD1 antibody. There will be four cohorts of patients with different types of cancer, all of whom have not responded well to other treatments.

Who is the study for?

This trial is for adults with certain advanced solid tumors, specifically metastatic or recurrent urothelial carcinoma that's resistant to platinum-based treatment, and locally advanced prostate cancer. Participants must have adequate organ function, no recent other treatments or surgeries, and agree to use contraception. Those with active pneumonitis, uncontrolled hypertension, known psychiatric disorders affecting cooperation, prior anti-PD-1/PD-L1 therapy or sEphB4-HSA are excluded.

What is being tested?

The trial tests a combination of sEphB4-HSA (a fusion protein blocking cell surface receptors) and Pembrolizumab (an anti-PD1 antibody) on four cohorts: two for second and third-line treatment of urothelial carcinoma after platinum failure; one as neoadjuvant for muscle invasive urothelial carcinoma; another as neoadjuvant for prostate cancer.

What are the potential side effects?

Potential side effects include immune-related reactions like inflammation in various organs due to the body's immune system becoming overactive. There may also be infusion-related reactions from the drugs being administered into the bloodstream and typical chemotherapy-associated effects such as fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My bladder cancer is at a stage where surgery to remove it is planned and considered potentially curative.

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My liver function tests are within the required range.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My kidney function, measured by creatinine clearance or GFR, is adequate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with HIV.

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I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

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I have an active tuberculosis infection.

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I have been treated with specific immune therapy drugs before.

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I have or had lung inflammation not caused by an infection.

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I have not received a live vaccine within the last 30 days.

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I do not have severe heart issues, uncontrolled diabetes, or severe lung problems that required hospitalization in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of toxicities and adverse events classified according to the Common Terminology Criteria for Adverse Events v4.03

Secondary study objectives

OR defined as complete response or partial response according to RECIST v 1.1

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (EphB4-HSA and pembrolizumab)Experimental Treatment5 Interventions

Patients receive recombinant EphB4-HSA fusion protein 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Pembrolizumab

2017

Completed Phase 3

~2810