Phase II Single-Arm Study of Durvalumab and Bevacizumab Following Transarterial Radioembolization Using Yttrium-90 Glass Microspheres (TheraSphere™) in Unresectable Hepatocellular Carcinoma Amenable to Locoregional Therapy

UVA Tracking #
301080
Principal Investigator
Tri M Le
Contact
Contact Phone
Official Trial Title
Phase II Single-Arm Study of Durvalumab and Bevacizumab
Following Transarterial Radioembolization Using Yttrium-90
Glass Microspheres (TheraSphere™) in Unresectable
Hepatocellular Carcinoma Amenable to Locoregional Therapy
Study Description

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with liver cancer that have no systemic diseases or active infections. In this study, you will undergo a series of tests, both before and after your TARE procedure (a form of internal radiation therapy used primarily to treat liver tumors), to see if you are eligible to be in the study. On Day 14 of Cycle 1, the study drug durvalumab will be given alone as an IV infusion (injected slowly into a vein) or through an implanted catheter (if you have one in place) at the clinic. Durvalumab is a type of immune therapy which may helps the body to improve its immune response to cancer. 14 days after receiving durvalumab immune therapy, you will begin to receive durvalumab as well as bevacizumab
You will be given durvalumab + bevacizumab until your cancer worsens, you experience side effects requiring discontinuation, you withdraw your consent, the study ends, or other reasons to discontinue study treatment occur. There is no certainty that you will have any benefit from the study treatment. However, based on our research it is thought that your condition could improve, or the study drugs could keep you from getting worse. This study may also help doctors learn things that can help other people in the future.

If you are enrolled in treatment, you may need to have the following exams, tests, and procedures:
• Physical examination
• Blood sampling
• Urine sampling
• Electrocardiograms (ECGs)
• Pregnancy test
• Safety monitoring and performance status
• Tumor assessment
• Upper endoscopy
• Angiogram
• Electronic questionnaires
• Tumor sample/biopsy (archived)

You will be in the study for 3 periods: screening, study treatment, and follow-up (for an expected average of about 2 years).

Additional information found here: https://www.clinicaltrials.gov/study/NCT06040099?titles=EMERALD-Y90&ran…

Compensation

No Compensation