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Monoclonal Antibodies

Pembrolizumab + Bavituximab for Liver Cancer

Phase 2
Waitlist Available
Led By David Hsieh, 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing pembrolizumab and bavituximab to see if they are effective in treating locally advanced HCC.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate
Secondary outcome measures
Overall Survival
Safety and Tolerability: rates of adverse events according to the CTCAE
Other outcome measures
Treatment response

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 2
~1950
Bavituximab
2011
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

David HsiehLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,862 Previous Clinical Trials
5,049,664 Total Patients Enrolled
2 Trials studying Liver Cancer
133 Patients Enrolled for Liver Cancer
Muhammad BegLead Sponsor

Media Library

Bavituximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03519997 — Phase 2
Liver Cancer Research Study Groups: Pembro + Bavi
Liver Cancer Clinical Trial 2023: Bavituximab Highlights & Side Effects. Trial Name: NCT03519997 — Phase 2
Bavituximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03519997 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do you have any openings for enrollees in this clinical trial?

"Correct. According to the information on clinicaltrials.gov, this trial is presently accepting participants since it was first posted in April 2018 and updated most recently in April 2022. To reach their goal of 28 individuals, only one location needs to be staffed with volunteers for enrollment."

Answered by AI

To what degree could Pembrolizumab potentially be detrimental to patients?

"With a score of 2, our team at Power has evaluated the safety profile of Pembrolizumab to be adequate due to existing data that indicates it is safe but there being no trial-based evidence for efficacy."

Answered by AI

What is the size of the cohort being monitored for this research?

"Affirmative. According to the info on clinicaltrials.gov, this medical study is currently searching for trial participants; it was first posted in April 2018 and last updated in April 2022. 28 people are being sought from a single site."

Answered by AI

Have there been previous examinations of Pembrolizumab as a therapeutic approach?

"Currently, there is an abundance of active trials concerning pembrolizumab with 122 reaching the Phase 3 phase. It appears to be most popularly studied in Houston, Texas out of a total of 35,731 locations across the world conducting research on it."

Answered by AI

What medical conditions can be effectively treated with Pembrolizumab?

"Pembrolizumab is often prescribed in order to combat malignant neoplasms, as well as non-operable melanomas, microsatellite instability high levels and post-chemotherapy disease progression."

Answered by AI
~0 spots leftby Apr 2024