Pembrolizumab + Bavituximab for Liver Cancer

Overseen By Ellen Siglinsky

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: David Hsieh

Must be taking: Antivirals

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Heart disease, HIV, Autoimmune, 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

Compensation: Varies

Number of Visits: 3

Duration: 36 months

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two drugs, pembrolizumab and bavituximab, in patients with advanced liver cancer that can't be treated with surgery. Pembrolizumab has shown effectiveness in various cancers, including liver cancer. The drugs work by helping the immune system attack the cancer and disrupting the tumor's blood supply. Patients will continue treatment as long as it is effective and they can tolerate it.

Who Is on the Research Team?

David Hsieh, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

Adults with advanced liver cancer (Hepatocellular Carcinoma) that can't be treated with surgery or local therapies, and who haven't had systemic therapy for it. They should have a good level of liver function (Child-Pugh Score A), no recent heart issues, controlled hepatitis if present, and not be on certain medications like high-dose steroids. Women must test negative for pregnancy and all participants must agree to use contraception.

Inclusion Criteria

My cancer can be measured on scans and is at least 1 cm big.

My cancer has spread beyond its original location.

I am fully active or can carry out light work.

Exclusion Criteria

I haven't had major surgery in the last 2 weeks or still have side effects.

I have not had any bleeding in my stomach or intestines in the last 2 months.

I have active brain tumors causing symptoms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab and bavituximab until disease progression, unacceptable toxicity, or withdrawal

36 months

Pembrolizumab every 3 weeks, Bavituximab weekly

Safety Follow-up

A mandatory safety follow-up is conducted 30 days post the last dose

4 weeks

Survival Follow-up

Patients are monitored for survival every 3 months after treatment discontinuation

Until death or study termination

What Are the Treatments Tested in This Trial?

Interventions

• Bavituximab
• Pembrolizumab

Trial Overview The trial is testing the combination of two drugs: Pembrolizumab and Bavituximab in patients with advanced Hepatocellular Carcinoma. It's an open-label phase II study which means everyone gets the treatment and both the researchers and participants know what's being given.

How Is the Trial Designed?

Group I: Pembro + Bavi Experimental Treatment 2 Interventions

Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly

Who Is Running the Clinical Trial?

David Hsieh

Lead Sponsor

Trials

1

Recruited

40+

Muhammad Beg

Lead Sponsor

Trials

1

Recruited

40+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University