EphB4-HSA + Pembrolizumab for Cancer

Overseen By Gina Tse, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Active TB, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

Duration: Up to 24 months

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase IIa trial studies how well recombinant EphB4-HSA fusion protein and pembrolizumab work in treating patients with non-small cell lung cancer that has spread to other places in the body or head and neck squamous cell cancer that has come back or spread to other places in the body. Recombinant EphB4-HSA fusion protein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of cancer cells to grow and spread. Giving recombinant EphB4-HSA fusion protein and pembrolizumab may work better in treating patients with non-small cell lung or head and neck squamous cell cancer.

Who Is on the Research Team?

Jorge J. Nieva

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.

Exclusion 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.

Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab IV on day 1 and recombinant EphB4-HSA fusion protein IV on days 1, 8, and 15, with courses repeating every 3 weeks for up to 24 months

Up to 24 months

3 visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

30 days and then every 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pembrolizumab
• Recombinant EphB4-HSA Fusion Protein

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (pembrolizumab, sEphB4-HSA) Experimental Treatment 3 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.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+