A Phase III Study of Durvalumab, Tremelimumab, and Transarterial Chemoembolization (TACE) Given with or without Lenvatinib Compared to TACE Alone in People with Localized Liver Cancer

Share

Full Title

A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination with Tremelimumab ± Lenvatinib Given Concurrently with Transarterial Chemoembolization (TACE) Compared to TACE Alone in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-3) (WCGIRB)

Purpose

This study is comparing the safety and effectiveness of durvalumab, tremelimumab, and transarterial chemoembolization (TACE) given with or without lenvatinib compared with TACE alone in people who have localized liver cancer that cannot be cured with surgery, transplantation, or ablation.

TACE is a treatment in which chemotherapy and an embolic agent (which blocks blood flow) are injected into the hepatic (liver) artery. Durvalumab and tremelimumab are immunotherapies already approved for liver cancer and are given intravenously (by vein). Lenvatinib is a biologic drug also already approved for liver cancer and is taken orally (by mouth).

Participants will be randomly assigned to receive one of these treatments:

  • Durvalumab, tremelimumab, lenvatinib, and TACE
  • Durvalumab, tremelimumab, and TACE
  • TACE alone

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have liver cancer (also known as hepatocellular carcinoma) that has not grown outside the liver and cannot be cured with surgery, transplantation, or ablation.
  • Patients may not have previously received anticancer medications for liver cancer.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Ghassan Abou-Alfa at 646-888-4184.

Protocol

22-330

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05301842