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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
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.Check my eligibility
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.See study design
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 belowSelect...
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:Select...
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Heart rate
Secondary outcome measures
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 moreOther outcome measures
Biomarker analysis of PD-1 and PD-L1 assessed by archived tumor tissue by immunohistochemical testing
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 2
~2010
Find a Location
Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
919 Previous Clinical Trials
1,611,399 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,359 Total Patients Enrolled
Jorge Nieva, MDPrincipal InvestigatorUniversity of Southern California
1 Previous Clinical Trials
250 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have an active tuberculosis infection.You have an active hepatitis B or C infection.My kidney function is within the normal range or slightly above.My blood clotting time is normal or managed with medication.I am a man who can father a child and will use birth control during and for 4 months after the study.I have not received a live vaccine in the last 30 days.Women who can have children should have a negative pregnancy test before starting the study treatment. If the urine test is positive or not clear, a blood test will be needed.I have had up to 2 chemotherapy treatments before.I have refused first-line platinum-based chemotherapy.My cancer returned within 6 months after treatment with cisplatin.Your absolute neutrophil count is at least 1,500 per microliter.I am currently being treated for an infection.I agree to use birth control during and up to 120 days after the study.I am fully active or restricted in physically strenuous activity but can do light work.I have been treated with specific immune system targeting drugs before.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.I have stable brain metastases, not on steroids for 7 days, and no new brain growths.I have a history of or currently have non-infectious lung inflammation.I agree to provide a tissue sample from my tumor after 2 treatment cycles.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.My lung cancer has worsened after chemotherapy.My cancer progressed despite treatment with specific targeted therapy.My head or neck cancer got worse after platinum-based treatment.My cancer has returned or spread to other parts of my body.You are allergic to pembrolizumab or any of the ingredients in it.My blood clotting time is normal or managed if I'm on blood thinners.Your albumin level in the blood is at least 2.5 mg/dL.I haven't had cancer treatment in the last 2 weeks or I've recovered from its side effects.You have a measurable tumor according to specific guidelines.My hemoglobin level is above 9 g/dL without needing transfusions or EPO recently.Your AST and ALT levels in your blood are not too high.I have been diagnosed with HIV.You have enough platelets in your blood (at least 100,000 per microliter).I have another cancer, but it's either not growing or doesn't need treatment, except for certain skin cancers or cervical cancer that's been treated.Your bilirubin levels in the blood should not be too high.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, sEphB4-HSA)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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