A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma

NCT03519997 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: STU 102017-015
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

Brief Summary

This is a non-randomized, open-label, multi-site phase II therapeutic trial of pembrolizumab and bavituximab in patients with locally advanced HCC. Locally advanced or metastatic HCC is defined as disease that is not amenable to surgical and/or locoregional therapies. Subjects must not have received prior systemic therapy for advanced HCC in keeping with the first-line setting of this study.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate

  To determine the overall response rate (ORR) defined as the number of complete or partial responses according to RECIST 1.1 divided by the number of evaluable patients treated with combination pembrolizumab and bavituximab in patients with advanced HCC.

  36 months

Secondary Outcomes (2)

• Overall Survival

  36 months

• Number of Adverse Events According to the CTCAE

  36 months

Study Arms (1)

Pembro + Bavi

EXPERIMENTAL

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

Drug: Pembrolizumab; Drug: Bavituximab

Interventions

Pembrolizumab DRUG

Pembroluzumab 200mg IV once every 3 weeks

Pembro + Bavi

Bavituximab DRUG

Bavituximab 3mg/kg IV weekly

Pembro + Bavi

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have a histologically confirmed diagnosis hepatocellular carcinoma; known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC will be excluded
• Locally advanced or metastatic disease
• Patients with locally advanced or metastatic disease must have disease deemed not amenable to surgical and/or locoregional therapies or patients who have progressed following surgical and/or locoregional therapies.
• Measurable disease, as 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).
• Child-Pugh Score A
• Age ≥ 18 years
• ECOG Performance score of 0-1
• Life expectancy greater than 6 months
• 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

You may not qualify if:

• Prior liver transplant;
• Patient who has received previous systemic therapy for HCC;
• Clinically significant, uncontrolled heart disease and/or recent events including any of the following:
• History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 12 months prior to screening;
• History of documented congestive heart failure (New York Heart Association functional classification III-IV);
• Documented cardiomyopathy;
• Patient has a left ventricular ejection fraction \<40% as determined by MUGA scan or ECHO (MUGA and ECHO are not required prior to enrollment);
• Known human immunodeficiency virus (HIV) positive (testing not required);
• History of thromboembolic events (including both pulmonary embolism and deep venous thrombus but not including tumor thrombus) within the last 6 months;
• Hypersensitivity to IV contrast; not suitable for pre-medication;
• Active or fungal infections requiring systemic treatment within 7 days prior to screening;
• Known history of, or any evidence of, interstitial lung disease or active non-infectious pneumonitis;
• Evidence of poorly controlled hypertension which is defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg despite optimal medical management;
• Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication;
• Active, known, or suspected autoimmune disease with the following exceptions i) Subjects with vitiligo, type I diabetes mellitus, resolved childhood asthma or atopy are permitted to enroll; ii) Subjects with suspected autoimmune thyroid disorders may be enrolled if they are currently euthyroid or with residual hypothyroidism requiring only hormone replacement.

Sponsors & Collaborators

• David Hsieh: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Parkland Health & Hospital System

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

pembrolizumab; bavituximab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: David Hsieh
• Organization: University Texas Southwestern Medical Center

David.Hsieh@UTSouthwestern.edu

214/648-4180

Study Officials

• David Hsieh, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR- Internal Medicine - IM-Hem Onc

Model Details: Locally advanced or metastatic HCC not amenable to locoregional therapy

Study Record Dates

• First Submitted: April 26, 2018
• First Posted: May 9, 2018
• Study Start: April 26, 2018
• Primary Completion: April 21, 2023
• Study Completion: April 1, 2026
• Last Updated: February 11, 2026
• Results First Posted: July 17, 2024

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)