Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 10:15 PM
Study NCT ID:
NCT07081633
Status:
RECRUITING
Last Update Posted:
2025-10-29
First Post:
2025-06-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613593', 'term': 'durvalumab'}, {'id': 'C520704', 'term': 'tremelimumab'}, {'id': 'C531958', 'term': 'lenvatinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 114}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-28', 'studyFirstSubmitDate': '2025-06-23', 'studyFirstSubmitQcDate': '2025-07-15', 'lastUpdatePostDateStruct': {'date': '2025-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression free survival (PFS) per RECIST 1.1', 'timeFrame': 'From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed.', 'description': 'Efficacy endpoint'}], 'secondaryOutcomes': [{'measure': 'Grade ≥ 3 TRAE within 6 months after the initiation of study intervention', 'timeFrame': 'From first dose to 6 months after the initiation of study intervention', 'description': 'safety endpoint'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of the first dose of study intervention until death due to any cause. It will be assessed when approximately 69 OS events have occurred (60% maturity), approximately 24 months after last participant has been assigned to study intervention.', 'description': 'Efficacy endpoint'}, {'measure': 'Objective Response Rate (ORR) per RECIST 1.1', 'timeFrame': 'From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention.', 'description': 'Efficacy endpoint'}, {'measure': 'Disease Control Rate (DCR) per RECIST 1.1', 'timeFrame': 'From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention.', 'description': 'Efficacy endpoint'}, {'measure': 'Duration of response (DoR) per RECIST 1.1', 'timeFrame': 'From the date of response until the date of objective PD per RECIST 1.1 or death, whichever came first. It is anticipated that this analysis will be performed approximately 8 months after the last patient dosed.', 'description': 'Efficacy endpoint'}, {'measure': 'Progression Free Survival (PFS) per mRECIST', 'timeFrame': 'From the date of the first dose until the date of objective PD per mRECIST or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed.', 'description': 'Efficacy endpoint'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': 'This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.\n* Must not have received prior systemic therapy for unresectable HCC.\n* Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.\n* Child-Pugh Score class A.\n* ECOG performance status of 0 or 1 at enrollment.\n* At least 1 measurable lesion per RECSIT 1.1 guidelines\n\nExclusion Criteria:\n\n* Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.\n* History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.\n* Clinically meaningful ascites.\n* Patients with main portal vein thrombosis.\n* Active or prior documented GI bleeding.\n* Patient currently exhibits symptomatic or uncontrolled hypertension.\n* Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)\n* Uncontrolled intercurrent illness'}, 'identificationModule': {'nctId': 'NCT07081633', 'acronym': 'TREMENDOUS-2', 'briefTitle': 'Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An Open-label, Multi-center Phase II Study of Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'D419CL00025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm', 'description': 'Durvalumab and Tremelimumab with Lenvatinib', 'interventionNames': ['Drug: Durvalumab', 'Drug: Tremelimumab', 'Combination Product: Lenvatinib']}], 'interventions': [{'name': 'Durvalumab', 'type': 'DRUG', 'otherNames': ['MEDI4736'], 'description': 'Durvalumab IV (intravenous infusion)', 'armGroupLabels': ['Single Arm']}, {'name': 'Tremelimumab', 'type': 'DRUG', 'description': 'Tremelimumab IV (intravenous infusion)', 'armGroupLabels': ['Single Arm']}, {'name': 'Lenvatinib', 'type': 'COMBINATION_PRODUCT', 'description': 'Lenvatinib Oral', 'armGroupLabels': ['Single 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'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '210029', 'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '315010', 'city': 'Ningbo', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}, {'zip': '200032', 'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200438', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '030001', 'city': 'Taiyuan', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'zip': '300060', 'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '325000', 'city': 'Wenzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'zip': '430030', 'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '361004', 'city': 'Xiamen', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'zip': '450052', 'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'AstraZeneca Clinical Study Information Center', 'role': 'CONTACT', 'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitment at made to the EFPIA Pharma Data Sharing Principles .For details of our timeline please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nPlan Description: All request will be evaluated as per the Az disclosure commitment:\n\nhttps://astrazenecaarouptrials.pharmacm.com/ST/Submission/Disclosure Yes. indicates that Az are accepting requests for IPD ,but this does not mean are quests will be shared', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool.\n\nSigned 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 a air access. For additional details. please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}