Trial record 1 of 2 for:
NCT03847428
Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment (EMERALD-2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03847428 |
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Recruitment Status :
Active, not recruiting
First Posted : February 20, 2019
Last Update Posted : February 21, 2023
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma | Drug: Durvalumab Drug: Bevacizumab Other: Placebo | Phase 3 |
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 908 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation |
| Actual Study Start Date : | April 29, 2019 |
| Estimated Primary Completion Date : | May 31, 2023 |
| Estimated Study Completion Date : | May 31, 2024 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm A
Durvalumab 1120 mg (Q3W) + bevacizumab 15 mg/kg (Q3W)
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Drug: Durvalumab
Durvalumab IV (intravenous)
Other Name: IMFINZI Drug: Bevacizumab Bevacizumab IV (intravenous)
Other Name: AVASTIN |
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Experimental: Arm B
Durvalumab 1120 mg (Q3W) + bevacizumab placebo (Q3W)
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Drug: Durvalumab
Durvalumab IV (intravenous)
Other Name: IMFINZI Other: Placebo Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking |
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Placebo Comparator: Arm C
Durvalumab placebo (Q3W) + bevacizumab placebo (Q3W)
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Other: Placebo
Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking |
Primary Outcome Measures :
- Recurrence-free survival (RFS) for Arm A vs Arm C [ Time Frame: Up to 49 months after first patient randomized ]RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
Secondary Outcome Measures :
- Recurrence-free survival (RFS) Arm B vs Arm C [ Time Frame: Up to 49 months after first patient randomized ]RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.
- Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: No timeframe ]OS is defined as the time from the date of randomization until death due to any cause
- Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: At 24 and at 36 months ]Proportion of RFS at 24 months and at 36 months
- Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 49 months after first patient randomized ]TTR is defined as the time from the date of randomization until the date of disease recurrence
- Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C [ Time Frame: Up to 49 months after first patient randomized ]Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 150 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
- Imaging to confirm disease-free status within 28 days prior to randomization
- ECOG 0-1 at enrolment
- Child-Pugh score of 5 or 6
- Adequate organ and marrow function.
Exclusion Criteria:
- Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
- Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
- History of hepatic encephalopathy within 12 months prior to randomization
- Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
- Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
- Active co-infection with HBV and HDV.
- Receipt of prior systemic anticancer therapy for HCC
- Those on a waiting list for liver transplantation
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03847428
Locations
Show 214 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Jia Fan, PhD | Liver Cancer Institute Zhongshan Hospital, Fudan University | |
| Principal Investigator: | Jennifer Knox, MD | Solid Tumor Medical Oncology Princess Margaret Cancer Centre |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT03847428 |
| Other Study ID Numbers: |
D910DC00001 2018-004105-85 ( EudraCT Number ) |
| First Posted: | February 20, 2019 Key Record Dates |
| Last Update Posted: | February 21, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure |
| Access Criteria: | When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure |
| URL: | https://astrazenecagroup-dt.pharmacm.com/DT/Home |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AstraZeneca:
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Early stage HCC Durvalumab Bevacizumab Liver Cancer |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Hepatocellular Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
Disease Attributes Pathologic Processes Bevacizumab Durvalumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |