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Monoclonal Antibodies

Durvalumab + Bevacizumab for Liver Cancer (EMERALD-2 Trial)

Phase 3
Waitlist Available
Led By Jia Fan, PhD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
Adequate organ and marrow function.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 and at 36 months
Awards & highlights

EMERALD-2 Trial Summary

This trial is testing if a combination of two drugs, durvalumab and bevacizumab, can help treat patients with hepatocellular carcinoma who are at high risk of the cancer coming back.

Who is the study for?
This trial is for patients with a specific liver cancer (HCC) who've had successful curative therapy like surgery or ablation and are currently disease-free. They should be in good physical condition (ECOG 0-1), have a stable liver function score (Child-Pugh 5 or 6), and their organs must work well. People with certain types of HCC, evidence of spread, previous hepatic encephalopathy, portal vein thrombosis, co-infections, those awaiting liver transplants, or at risk of bleeding varices can't join.Check my eligibility
What is being tested?
The study tests the effectiveness and safety of Durvalumab alone or combined with Bevacizumab in preventing cancer recurrence in high-risk HCC patients after they've received curative treatment. Patients will be randomly assigned to receive either both drugs together, Durvalumab alone, or a placebo to compare outcomes.See study design
What are the potential side effects?
Durvalumab may cause immune-related reactions affecting various organs; skin issues; fatigue; infections due to lowered immunity. Bevacizumab might lead to high blood pressure; bleeding; blood clots; headaches; proteinuria. Side effects vary among individuals.

EMERALD-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with liver cancer and completed curative therapy.
Select...
My organs and bone marrow are working well.
Select...
I am fully active or can carry out light work.
Select...
My liver function is slightly impaired.

EMERALD-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 and at 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 24 and at 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recurrence-free survival (RFS) for Arm A vs Arm C
Secondary outcome measures
Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C
Recurrence-free survival (RFS) Arm B vs Arm C
Upper arm
+2 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Urinary tract infection
20%
Dyspnea
18%
Rash maculo-papular
15%
Abdominal Pain
15%
Back pain
15%
Weight gain
15%
Cough
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Anal pain
8%
Dry skin
8%
Urinary frequency
8%
Edema limbs
8%
Flatulence
8%
Myalgia
8%
Hot flashes
8%
Thromboembolic event
8%
Fever
8%
Colitis
8%
Dry mouth
8%
Headache
8%
Small intestinal obstruction
8%
Urinary tract pain
5%
Ascites
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Confusion
5%
Gastroesophageal reflux disease
5%
Anemia
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Rash acneiform
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Upper respiratory infection
3%
Rectal hemorrhage
3%
CPK increased
3%
Fall
3%
Skin infection
3%
Muscle weakness left-sided
3%
Myositis
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Pain in extremity
3%
Blood bilirubin increased
3%
Rectal pain
3%
Weight Loss
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Creatinine increased
3%
Lethargy
3%
Left ventricular systolic dysfunction
3%
Dysarthria
3%
Hypothyroidism
3%
Myocarditis
3%
Pleural effusion
3%
Hyperkalemia
3%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

EMERALD-2 Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm BExperimental Treatment2 Interventions
Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
Group II: Arm AExperimental Treatment2 Interventions
Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
Group III: Arm CPlacebo Group1 Intervention
Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bevacizumab
2013
Completed Phase 4
~5280
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,448,913 Total Patients Enrolled
2 Trials studying Liver Cancer
1,040 Patients Enrolled for Liver Cancer
Jia Fan, PhDPrincipal InvestigatorLiver Cancer Institute Zhongshan Hospital, Fudan University
1 Previous Clinical Trials
600 Total Patients Enrolled
Jennifer Knox, MDPrincipal InvestigatorSolid Tumor Medical Oncology Princess Margaret Cancer Centre
7 Previous Clinical Trials
965 Total Patients Enrolled
3 Trials studying Liver Cancer
61 Patients Enrolled for Liver Cancer

Media Library

Bevacizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03847428 — Phase 3
Liver Cancer Research Study Groups: Arm B, Arm A, Arm C
Liver Cancer Clinical Trial 2023: Bevacizumab Highlights & Side Effects. Trial Name: NCT03847428 — Phase 3
Bevacizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03847428 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there specific inclusion criteria for potential participants of this clinical trial?

"The eligibility requirements for this study are that patients must have carcinoma, hepatocellular and be within the ages of 18 and 150. So far, 908 people have been recruited."

Answered by AI

Are there other cases where Durvalumab has been studied before?

"The immunotherapy drug durvalumab was first studied in 2004 at the MSK Basking Ridge facility (Follow Up Only). Since then, there have been 19371 completed studies worldwide. As of now, 701 clinical trials are still recruiting patients; a majority of these trials taking place in Toronto, Canada."

Answered by AI

If an elderly person wanted to participate in this trial, would they be allowed?

"Individuals aged 18 to 150 that meet the other requirements set by the research team conducting this trial are eligible to apply. Out of the 4051 trials taking place for people over 65, this is one of 267 trials involving individuals under 18 years old."

Answered by AI

Are patients still being signed up for this research project?

"Unfortunately, this study has already closed recruitment. The posting date was April 29th, 2019 and the last update was on November 17th, 2022. However, there are presently 3517 trials actively recruiting participants with carcinoma and 701 studies for Durvalumab that are still looking for volunteers."

Answered by AI

What is the total number of participants in this trial?

"Right now, this study is not looking for any more patients. However, it's worth noting that the last update was on November 17th, 2022 and the study was originally posted on April 29th, 2019. If you're interested in other trials, 3517 studies involving carcinoma hepatocellular are actively recruiting participants and 701 studies have open Durvalumab slots."

Answered by AI

Has Durvalumab been cleared by the FDA?

"There is both some efficacy data and multiple rounds of safety data, so Durvalumab received a score of 3."

Answered by AI

What conditions respond best to Durvalumab?

"Durvalumab is often used to treat recurrent platinum drug resistant primary peritoneal cancer. This immunotherapy medication can also be given to patients with various other conditions including previously untreated, disease, and recurrent non-squamous non-small cell lung cancer."

Answered by AI

At how many different medical facilities can patients enroll in this clinical trial?

"At the moment, this trial is recruiting patients from 34 sites. Those in Toronto, Omaha and Ottawa (among other locations) are encouraged to apply to the site closest to them to cut down on travel time if they enroll."

Answered by AI
~71 spots leftby Aug 2024