Trial Outcomes & Findings for A Study of Pembrolizumab and Bavituximab in Patients With Advanced Hepatocellular Carcinoma (NCT NCT03519997)

NCT ID: NCT03519997

Last Updated: 2026-02-11

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

35 participants

Primary outcome timeframe

36 months

Results posted on

2026-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Pembro + Bavi Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly Pembrolizumab: Pembroluzumab 200mg IV once every 3 weeks Bavituximab: Bavituximab 3mg/kg IV weekly
Overall Study STARTED	35
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Pembro + Bavi Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly Pembrolizumab: Pembroluzumab 200mg IV once every 3 weeks Bavituximab: Bavituximab 3mg/kg IV weekly
Overall Study Adverse Event	4
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembro + Bavi n=28 Participants Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly Pembrolizumab: Pembroluzumab 200mg IV once every 3 weeks Bavituximab: Bavituximab 3mg/kg IV weekly
Age, Categorical <=18 years	0 Participants n=41 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=41 Participants
Age, Categorical >=65 years	13 Participants n=41 Participants
Sex: Female, Male Female	4 Participants n=41 Participants
Sex: Female, Male Male	24 Participants n=41 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=41 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=41 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants
Race (NIH/OMB) Black or African American	14 Participants n=41 Participants
Race (NIH/OMB) White	14 Participants n=41 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants
Region of Enrollment United States	28 participants n=41 Participants

PRIMARY outcome

Timeframe: 36 months

Outcome measures

Outcome measures
Measure	Pembro + Bavi n=28 Participants Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly Pembrolizumab: Pembroluzumab 200mg IV once every 3 weeks Bavituximab: Bavituximab 3mg/kg IV weekly
Overall Response Rate	9 Participants

SECONDARY outcome

Timeframe: 36 months

To determine overall survival, 6-month progression free survival, and duration of response of combination pembrolizumab and bavituximab compared to historical controls

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 36 months

Population: All patients who received at least one dose of study treatment

To determine the safety and tolerability of combination pembrolizumab and bavituximab as measured by the number of adverse events according to the CTCAE 5.0

Outcome measures

Outcome measures
Measure	Pembro + Bavi n=35 Participants Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly Pembrolizumab: Pembroluzumab 200mg IV once every 3 weeks Bavituximab: Bavituximab 3mg/kg IV weekly
Number of Adverse Events According to the CTCAE	33 Adverse events

Adverse Events

Pembro + Bavi

Serious events: 7 serious events

Other events: 33 other events

Deaths: 14 deaths

Serious adverse events

Serious adverse events
Measure	Pembro + Bavi n=35 participants at risk Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly Pembrolizumab: Pembroluzumab 200mg IV once every 3 weeks Bavituximab: Bavituximab 3mg/kg IV weekly
Hepatobiliary disorders Hepatic failure	5.7% 2/35 • Number of events 2 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Gastrointestinal disorders colitis	2.9% 1/35 • Number of events 1 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Respiratory, thoracic and mediastinal disorders cough	2.9% 1/35 • Number of events 1 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Infections and infestations fever	2.9% 1/35 • Number of events 1 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Renal and urinary disorders acute kidney insufficiency	5.7% 2/35 • Number of events 2 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Endocrine disorders hypoglycemia	2.9% 1/35 • Number of events 1 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Hepatobiliary disorders hepatic hemorrhage	2.9% 1/35 • Number of events 1 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
General disorders weakness	5.7% 2/35 • Number of events 2 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Renal and urinary disorders Renal calculi	2.9% 1/35 • Number of events 1 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Endocrine disorders hyperglycemia	2.9% 1/35 • Number of events 1 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Infections and infestations sepsis	5.7% 2/35 • Number of events 2 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE

Other adverse events

Other adverse events
Measure	Pembro + Bavi n=35 participants at risk Pembrolizumab 200 mg IV every 3 weeks plus, Bavituximab 3mg/kg IV weekly Pembrolizumab: Pembroluzumab 200mg IV once every 3 weeks Bavituximab: Bavituximab 3mg/kg IV weekly
General disorders fatigue	45.7% 16/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Blood and lymphatic system disorders Neutrophil decrease	20.0% 7/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Blood and lymphatic system disorders anemia	11.4% 4/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Gastrointestinal disorders constipation	11.4% 4/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Nervous system disorders dizziness	11.4% 4/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Gastrointestinal disorders vomiting	11.4% 4/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
General disorders fever	11.4% 4/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Nervous system disorders headache	11.4% 4/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Gastrointestinal disorders anorexia	8.6% 3/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Endocrine disorders hypoglycemia	8.6% 3/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Renal and urinary disorders creatinine increase	8.6% 3/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Gastrointestinal disorders Diarrhea	28.6% 10/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Skin and subcutaneous tissue disorders rash	28.6% 10/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Hepatobiliary disorders ALT increase	11.4% 4/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
Hepatobiliary disorders AST increase	28.6% 10/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE
General disorders Chills	11.4% 4/35 • The planned follow-up period was 36 months. However, due to patient deaths or lost to follow-up, not all patients had follow-up data for 36 months. The actual median follow-up time was 24 months. AEs determined according to CTCAE

Additional Information

David Hsieh

University Texas Southwestern Medical Center

Phone: 214/648-4180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place