A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE (EMERALD-Y90)
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| ClinicalTrials.gov Identifier: NCT06040099 |
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Recruitment Status :
Recruiting
First Posted : September 15, 2023
Last Update Posted : March 8, 2024
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatocellular Carcinoma (HCC) | Drug: Durvalumab Drug: Bevacizumab Procedure: Transarterial Radioembolization (TARE) | Phase 2 |
A Phase II single-arm study conducted in participants with unresectable Hepatocellular carcinoma (HCC) eligible for embolization and not eligible for or who have declined treatment with resection and/or ablation or liver transplant.
Participants with previous Transarterial Chemoembolization (TACE) or TARE associated with the curative setting are permitted with a 6-month washout.
Approximately 125 participants with unresectable but amenable to locoregional therapy HCC eligible for embolization will be enrolled in the study at approximately 20 sites in the US to treat approximately 100 participants.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official 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 |
| Actual Study Start Date : | February 13, 2024 |
| Estimated Primary Completion Date : | September 30, 2026 |
| Estimated Study Completion Date : | September 30, 2026 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Yttrium 90 glass microspheres TARE in combination with Durvalumab and Bevacizumab
Participants will undergo Yttrium 90 glass microspheres TARE according to the dosimetry recommendation.
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Drug: Durvalumab
Durvalumab IV (intravenous)
Other Name: MEDI4736, IMFINZI Drug: Bevacizumab Bevacizumab IV (intravenous)
Other Name: AVASTIN, ZIRABEV Procedure: Transarterial Radioembolization (TARE) Yttrium 90 glass microspheres will be administered
Other Name: TheraSphere |
Primary Outcome Measures :
- Progression Free Survival (PFS) [ Time Frame: From Day 1 until date of progressive disease or death [Approximately 3 years] ]PFS is defined as the time from Day 1 (day of TARE) until the date of progressive disease per modified Response Evaluation Criteria in Solid Tumors (mRECIST), as assessed by the investigator, or death due to any cause. It is measured to assess the efficacy of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Secondary Outcome Measures :
- Number of participants with Adverse events (AEs) [ Time Frame: From Screening (Day -28 to Day 1) until 90 days after the last dose of study drug ]To assess the safety of the sequence of TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy
- Objective Response Rate (ORR) [ Time Frame: From Day 1 until progression, or the last evaluable assessment in the absence of progression (Approximately 3 years) ]ORR is defined as the proportion of participants who have a confirmed complete response or partial response, as determined by the investigator per mRECIST. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
- Overall Survival (OS) [ Time Frame: Day 1 to 18 months or until death (Approximately 3 years) ]OS is defined as the time from the start of TARE until the date of death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
- Duration of Response (DoR) [ Time Frame: Time from first documented response until documented progression (Approximately 3 years) ]DoR is defined as the time from the date of first documented response until the date of documented progression per mRECIST as assessed by the investigator, or death due to any cause. It is assessed after TARE followed by durvalumab monotherapy followed by durvalumab + bevacizumab in participants with unresectable HCC amenable to locoregional therapy.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Participants with confirmed unresectable HCC
- Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume
- Participants with no evidence of extrahepatic disease on any available imaging
- Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE.
- Participants having Child-Pugh score class A.
- Participants having ECOG performance status of 0 or 1 at enrollment
- Adequate organ and marrow function
Exclusion Criteria:
- Disease amenable to curative surgery or transplantation or curative ablation.
- Participants co-infected with HBV and HDV
- Any history of nephrotic or nephritic syndrome.
- Clinically significant (eg, active) cardiovascular disease
- Participants with uncontrolled hypertension
- History of hepatic encephalopathy
- Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis.
- Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure
- Participant has received any prior anticancer systemic therapy for unresectable HCC.
- History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment.
- History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
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): NCT06040099
Contacts
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Locations
| United States, Colorado | |
| Research Site | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Research Site | Not yet recruiting |
| Gainesville, Florida, United States, 32608 | |
| Research Site | Not yet recruiting |
| Orlando, Florida, United States, 32804 | |
| United States, Georgia | |
| Research Site | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| United States, Missouri | |
| Research Site | Recruiting |
| Saint Louis, Missouri, United States, 63110 | |
| United States, New Jersey | |
| Research Site | Not yet recruiting |
| Trenton, New Jersey, United States, 08690 | |
| United States, New York | |
| Research Site | Not yet recruiting |
| Buffalo, New York, United States, 14263 | |
| Research Site | Not yet recruiting |
| New York, New York, United States, 10029 | |
| Research Site | Not yet recruiting |
| Rochester, New York, United States, 14642 | |
| United States, Ohio | |
| Research Site | Recruiting |
| Columbus, Ohio, United States, 43210 | |
| United States, Washington | |
| Research Site | Not yet recruiting |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| Research Site | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53215 | |
| Research Site | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
AstraZeneca
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT06040099 |
| Other Study ID Numbers: |
D933GC00002 |
| First Posted: | September 15, 2023 Key Record Dates |
| Last Update Posted: | March 8, 2024 |
| Last Verified: | March 2024 |
| 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. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. |
| 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 deidentified 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: | Yes |
Keywords provided by AstraZeneca:
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TARE Durvalumab Bevacizumab Liver Cancer Y90 |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases |
Liver Diseases Bevacizumab Durvalumab Antineoplastic Agents, Immunological Antineoplastic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |