What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as pembrolizumab (a PD-1 inhibitor) and bavituximab (a phosphatidylserine-targeting agent), have distinct side effect profiles. Pembrolizumab can cause immune-related adverse events including fatigue, rash, diarrhea, and liver enzyme abnormalities, with severe cases potentially leading to pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. Bavituximab's side effects are less well-documented but may involve immune modulation-related issues. Additionally, sorafenib, another common treatment, is known for causing hand-foot skin reactions, diarrhea, hypertension, and fatigue.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, particularly hepatocellular carcinoma (HCC). Sorafenib (Nexavar), a multitargeted tyrosine kinase inhibitor, was one of the first systemic therapies approved for advanced HCC. More recently, immune checkpoint inhibitors like nivolumab (Opdivo) and pembrolizumab (Keytruda), which target PD-1, have been approved for HCC, especially in cases where patients have been previously treated with sorafenib. Additionally, the combination of atezolizumab (a PD-L1 inhibitor) and bevacizumab (an anti-VEGF antibody) has shown significant efficacy and received FDA approval for unresectable or metastatic HCC. These treatments highlight the evolving landscape of immunotherapy and targeted therapy in liver cancer management.

What other types of research exist?

Promising novel alternatives to Pembrolizumab and Bavituximab for liver cancer patients include Atezolizumab plus Bevacizumab, which has shown significant efficacy in unresectable hepatocellular carcinoma, and Futibatinib, an FGFR1-4 inhibitor, which has demonstrated clinical activity in FGFR-aberrant tumors, including cholangiocarcinoma. These therapies represent potential options for patients considering treatment in 2024.

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Monoclonal Antibodies

Pembrolizumab + Bavituximab for Liver Cancer

Phase 2

Waitlist Available

Led By Muhammad Beg, MD

Research Sponsored by David Hsieh

Eligibility Criteria Checklist

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

Must have

Following baseline laboratory values: Total bilirubin ≤ 2.0 mg/ml, INR ≤ 1.7, Hgb ≥ 8.5 g/dl, AST, ALT ≤ 5 times ULN, Platelet count ≥ 50,000/mm3, Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min, Albumin ≥ 2.5 g/dl, Absolute neutrophil ≥ 1,500 cells/mm3, Male and female subjects of childbearing potential must agree to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication, Women of childbearing potential must have a negative pregnancy test, Subjects are eligible to enroll if they have non-viral-HCC, HBV-HCC, or HCV-HCC as defined in the text

Measurable disease defined as lesions that can accurately be measured in at least one dimension according to RECIST version 1.1 at least 1 cm with contrast-enhanced dynamic imaging (magnetic resonance imaging or computed tomography)

Must not have

Active gastrointestinal bleeding within previous 2 months

Symptomatic or clinically active brain metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune-related reactions affecting various organs, infusion-related reactions from receiving drugs through a vein, fatigue, potential blood disorders, increased risk of infections, as well as specific organ inflammation such as pneumonitis.

Eligibility Criteria

Inclusion Criteria

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

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

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My cancer has spread beyond its original location.

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I am fully active or can carry out light work.

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My liver functions well despite my illness.

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I have been diagnosed with a specific type of liver cancer, but not fibrolamellar, sarcomatoid, or mixed with bile duct cancer.

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My cancer cannot be treated with surgery or local therapies, or it has spread after such treatments.

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I am 18 years old or older.

Exclusion Criteria

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

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

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I have active brain tumors causing symptoms.

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I do not have serious, uncontrolled heart problems.

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My thyroid condition cannot be controlled with medication.

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I have an autoimmune disease.

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I have had treatment for liver cancer that spread through my body.

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My blood pressure is not well controlled.

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I have both active hepatitis B and C infections.

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I have noticeable fluid buildup in my abdomen.

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I am HIV positive.

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I have a history of lung disease or inflammation not caused by infection.

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I am allergic to ingredients in bavituximab, pembrolizumab, or similar drugs.

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I have had a liver transplant.

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I am on medication to prevent blood clots.

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I have previously received immunotherapy targeting PD-1, PD-L1, or PD-L2.

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I have had a blood clot in the past 6 months.

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I have an active tuberculosis infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Response Rate

Secondary study objectives

Number of Adverse Events According to the CTCAE

Overall Survival

Other study objectives

Treatment response

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: Pembro + BaviExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~2810

Bavituximab

2011

Completed Phase 2

~300

0 / 25Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cancer, such as Pembrolizumab and Bavituximab, work by enhancing the body's immune response and disrupting tumor growth. Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 receptor on T-cells, boosting the immune system's ability to attack cancer cells. Bavituximab targets phosphatidylserine on tumor blood vessels, disrupting the tumor's blood supply and enhancing immune response. These targeted therapies are important for liver cancer patients as they can improve survival rates and reduce tumor progression by specifically attacking cancer cells and their supportive structures.

A Single Nucleotide Mixture Enhances the Antitumor Activity of Molecular-Targeted Drugs Against Hepatocellular Carcinoma.