A global study to evaluate transarterial chemoembolization(TACE) in combination with durvalumab, tremelimumab +/-lenvatinib therapy compared to TACE alone in patients with locoregional hepatocellular carcinoma

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

21 Nov 2022 → ongoing

Decision date (initial)

2024-04-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2023-508701-24-00

EudraCT number

2021-003822-54

ClinicalTrials.gov

NCT05301842

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacogenomic

To demonstrate superiority of durvalumab + tremelimumab+ lenvatinib + TACE relative to TACE alone by assessment of PFS in participants with locoregional HCC

Secondary objectives 3

1. To demonstrate superiority of durvalumab + tremelimumab+ lenvatinib + TACE relative to TACE alone by assessment of OS in participants with locoregional HCC
2. To demonstrate superiority of durvalumab + tremelimumab+ TACE relative to TACE alone by assessment of PFS in participants with locoregional HCC
3. To demonstrate superiority of durvalumab + tremelimumab+ TACE relative to TACE alone by assessment of OS in participants with locoregional HCC

Conditions and MedDRA coding

Locoregional Hepatocellular Carcinoma (HCC)

Study design 3 periods

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD 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 Vivli.org. All requests 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. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. No evidence of extrahepatic disease
2. Disease not amenable to curative surgery or transplantation or curative ablation
3. Disease must be amenable to TACE
4. Child-Pugh score class A and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
6. Adequate organ and marrow function

Exclusion criteria 5

1. History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
2. History of encephalopathy within past 12 months
3. Uncontrolled arterial hypertension
4. Co-infection with HBV and HDV
5. Major portal vein thrombosis visible on baseline imaging

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR

Secondary endpoints 1

1. Overall Survival (OS)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

6 EU/EEA countries · 40 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 55 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications