Trial Outcomes & Findings for Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma (NCT NCT05249569)

Results Overview

To determine the objective response rate of combination axitinib,avelumab, and bavituximab in advanced HCC not previously treated with systemic therapy.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months.

Results posted on

2023-05-03

Participant Flow

Participant milestones

Participant milestones
Measure	Axitinib / Avelumab /Bavituximab Axitinib 5 mg PO BID Avelumab 10 mg/kg IV every 2 weeks (2 doses in a 4-week cycle) Bavituximab 3 mg/kg IV every 1 week (4 doses in a 4-week cycle) Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Axitinib: Axitinib to be administered orally BID Avelumab: Avelumab to be administered as a 1-hour IV infusion on Day 1 and Day 15 of each 28-day cycle. Bavituximab: Bavituximab to be administered weekly on Days 1, 8, 15 and 22 of the 28-day cycle.
Overall Study STARTED	1
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Axitinib / Avelumab /Bavituximab Axitinib 5 mg PO BID Avelumab 10 mg/kg IV every 2 weeks (2 doses in a 4-week cycle) Bavituximab 3 mg/kg IV every 1 week (4 doses in a 4-week cycle) Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Axitinib: Axitinib to be administered orally BID Avelumab: Avelumab to be administered as a 1-hour IV infusion on Day 1 and Day 15 of each 28-day cycle. Bavituximab: Bavituximab to be administered weekly on Days 1, 8, 15 and 22 of the 28-day cycle.
Overall Study Sponsor pulled support for one of the study drugs.	1

Baseline Characteristics

Study of Bavituximab, Axitinib, and Avelumab in Advanced Hepatocellular Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Axitinib / Avelumab /Bavituximab n=1 Participants Axitinib 5 mg PO BID Avelumab 10 mg/kg IV every 2 weeks (2 doses in a 4-week cycle) Bavituximab 3 mg/kg IV every 1 week (4 doses in a 4-week cycle) Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Axitinib: Axitinib to be administered orally BID Avelumab: Avelumab to be administered as a 1-hour IV infusion on Day 1 and Day 15 of each 28-day cycle. Bavituximab: Bavituximab to be administered weekly on Days 1, 8, 15 and 22 of the 28-day cycle.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	1 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	1 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants

PRIMARY outcome

Timeframe: Study treatment will continue until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason up to 24 months.

Population: One patient signed consent and was enrolled on study. The participant that was enrolled on the study did not receive treatment before the study was terminated. Data was not collected for this outcome measure.

To determine the objective response rate of combination axitinib,avelumab, and bavituximab in advanced HCC not previously treated with systemic therapy.