Trial details
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
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Trial short name: EMERALD-3
Official 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
Principal Investigator: Dr. Anthony Lott
Cancer type: Gastrointestinal
Cancer location: Gastrointestinal
Disease stage: Early Cancer
Trial phase: Phase 3
Intervention: Drug: Tremelimumab Drug: Durvalumab Procedure: Transarterial Chemoembolization (TACE) Drug: Lenvatinib
Registration #:
NCT05301842 
Contact e-mail: cancerclinicaltrials@sunnybrook.ca
Trial description:
This is a Phase III, parallel, randomized, open-label, sponsor-blinded, 3-arm, multicenter, international study assessing the efficacy and safety of durvalumab + tremelimumab + TACE with or without lenvatinib compared with TACE alone in participants with locoregional HCC not amenable to curative therapy (eg, surgical resection, transplantation, or ablation).
Key Inclusion Criteria: • Confirmed HCC (by imaging or histopathologically from biopsy specimen and/or surgery). • No evidence of extrahepatic disease on any available imaging. • Disease not amenable to curative surgery or transplantation or curative ablation. • Disease must be amenable to TACE. • Child-Pugh score class A (i.e., score of 5 to 6). • WHO or ECOG performance status of 0 or 1. • At least 1 measurable target intrahepatic lesion suitable for repeat assessments according to mRECIST. Key Exclusion Criteria: • Any evidence of uncontrolled systemic diseases, active systemic infection (except for HBV infection or HCV infection), active interstitial lung disease (ILD)/pneumonitis, serious chronic gastrointestinal conditions associated with diarrhea, psychiatric illness/social situations) or history of allogeneic organ transplant that, in the investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. • Uncontrolled arterial hypertension defined by a systolic pressure ≥ 150 mm Hg or diastolic pressure ≥ 90 mm Hg or other hypertensive cardiovascular complications despite standard medical management. • Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow a formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of lenvatinib. • History of another primary malignancy. • Persistent toxicities (Common Terminology Criteria for Adverse Events [CTCAE] Grade > 2) caused by previous anticancer therapy; alopecia and vitiligo are excluded toxicities. • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, etc. • Major portal vein thrombosis visible on baseline/eligibility imaging. Participants with Grade Vp3 and Vp4 are excluded. • Evidence by investigator assessment of varices at risk of bleeding on upper endoscopy undertaken at the screening visit, or within 6 months (24 weeks) of randomization.
