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Monoclonal Antibodies

EphB4-HSA + Pembrolizumab for Cancer

Phase 2

Waitlist Available

Led By Jorge Nieva, 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

Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale

Locally advanced or metastatic non-small cell lung cancer that has progressed after at least 1 line of platinum based chemotherapy

Must not have

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

Has a known history of active TB (Bacillus tuberculosis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a combination of a protein and an antibody to treat patients with non-small cell lung or head and neck squamous cell cancer.

Who is the study for?

This trial is for adults with certain advanced cancers, including non-small cell lung cancer and head and neck squamous cell carcinoma that have worsened despite treatment. Participants must have specific blood levels within normal ranges, be willing to provide tissue samples, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have had certain treatments recently or suffer from severe allergies or immune conditions.

What is being tested?

The study tests a combination of a recombinant EphB4-HSA fusion protein that may block tumor growth enzymes and pembrolizumab, an antibody that could prevent cancer cells from growing. It's for patients whose cancer has spread or returned after previous therapies. The goal is to see if this combo works better than current treatments.

What are the potential side effects?

Possible side effects include allergic reactions to the drug components (pembrolizumab), issues related to immune system suppression such as increased risk of infections, potential liver function changes reflected in blood tests, fatigue due to anemia or other causes related directly or indirectly to the treatment.

Eligibility Criteria

Inclusion Criteria

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

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

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My lung cancer has worsened after chemotherapy.

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My cancer progressed despite treatment with specific targeted therapy.

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My head or neck cancer got worse after platinum-based treatment.

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My kidney function is within the normal range or slightly above.

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My hemoglobin level is above 9 g/dL without needing transfusions or EPO recently.

Exclusion Criteria

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

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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 system targeting drugs before.

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

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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.

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I have a history of or currently have non-infectious lung inflammation.

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I am currently being treated for an infection.

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I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.

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I have been diagnosed with HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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

Heart rate

Secondary study objectives

Duration of response

Incidence of adverse events assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0

Overall survival (OS)

+1 more

Other study objectives

Biomarker analysis of PD-1 and PD-L1 assessed by archived tumor tissue by immunohistochemical testing

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 (pembrolizumab, sEphB4-HSA)Experimental Treatment3 Interventions

Patients receive pembrolizumab IV over 30 minutes on day 1 and recombinant EphB4-HSA fusion protein IV over 30 minutes on days 1, 8, and 15. Courses repeat every 3 weeks for up to 24 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 15Eligibility criteria met