Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

NCT05301842 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: D910VC000012023-508701-24-002021-003822-54
• Study Type: interventional
• Target: 760
• Locations: 22 countries
• Sites: 171

Brief Summary

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Locoregional HCC; Durvalumab; Tremelimumab; Lenvatinib; TACE; Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) for Arm A vs Arm C

  PFS is defined as time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause

  Approximately 5 years

Secondary Outcomes (3)

• Overall Survival (OS) for Arm A vs Arm C

  Approximately 5 years

• Progression Free Survival (PFS) for Arm B vs Arm C

  Approximately 5 years

• Overall Survival (OS) for Arm B vs Arm C

  Approximately 5 years

Study Arms (3)

Arm A

EXPERIMENTAL

Tremelimumab, Durvalumab and Lenvatinib in combination with Transarterial Chemoembolization (TACE)

Drug: Tremelimumab; Drug: Durvalumab; Procedure: Transarterial Chemoembolization (TACE); Drug: Lenvatinib

Arm B

EXPERIMENTAL

Tremelimumab and Durvalumab in combination with Transarterial Chemoemobolization (TACE)

Drug: Tremelimumab; Drug: Durvalumab; Procedure: Transarterial Chemoembolization (TACE)

Arm C

ACTIVE COMPARATOR

Transarterial Chemoembolization (TACE)

Procedure: Transarterial Chemoembolization (TACE)

Interventions

Tremelimumab DRUG

Tremelimumab IV (intravenous)

Also known as: MEDI1123

Arm A; Arm B

Durvalumab DRUG

Durvalumab IV (intravenous)

Also known as: MEDI4736

Arm A; Arm B

Transarterial Chemoembolization (TACE) PROCEDURE

TACE (chemo and embolic agent injection into the hepatic artery)

Also known as: DEB-TACE and cTACE

Arm A; Arm B; Arm C

Lenvatinib DRUG

Lenvatinib (oral)

Also known as: Lenvima

Arm A

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No evidence of extrahepatic disease
• Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
• Child Pugh score class A
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
• Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
• Adequate organ and marrow function

You may not qualify if:

• History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia
• History of hepatic encephalopathy
• Major portal vein thrombosis visible on baseline imaging
• Uncontrolled arterial hypertension
• Co-infection with HBV and HDV

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (171)

Research Site

Birmingham, Alabama, 35233, United States

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Mobile, Alabama, 36607, United States

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Yuma, Arizona, 85364, United States

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Glendale, California, 91204, United States

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Atlanta, Georgia, 30318, United States

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Baltimore, Maryland, 21201, United States

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Santa Fe, New Mexico, 87505, United States

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Commack, New York, 11725, United States

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New York, New York, 10029, United States

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Memphis, Tennessee, 38104, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77030, United States

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Brussels, 1070, Belgium

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Ghent, 9000, Belgium

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Barretos, 14784-400, Brazil

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Brasília, 71681-603, Brazil

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Niterói, 24020-096, Brazil

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Porto Alegre, 91350-200, Brazil

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Rio de Janeiro, 20231-050, Brazil

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Santa Maria, 97015-450, Brazil

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Santo André, 09060-650, Brazil

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São Paulo, 04014-002, Brazil

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Vitória, 29043-272, Brazil

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Calgary, Alberta, T2N 5G2, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Kingston, Ontario, K7L 5P9, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Toronto, Ontario, M5G 2M9, Canada

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Montreal, Quebec, H2X 3E4, Canada

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Montreal, Quebec, H4A 3J1, Canada

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Beijing, 100021, China

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Beijing, 100069, China

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Beijing, 100142, China

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Changchun, 130021, China

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Changsha, 410013, China

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Chengdu, 610041, China

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Fuzhou, 350001, China

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Fuzhou, 350011, China

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Guangzhou, 510060, China

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Guangzhou, 510515, China

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Haikou, 570311, China

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Hangzhou, 310022, China

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Harbin, 150081, China

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Hefei, 230031, China

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Lanzhou, 730030, China

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Lishui, 323000, China

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Nanchang, 330006, China

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Nanjing, 210002, China

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Nantong, 226361, China

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Neijiang, 641000, China

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Shanghai, 200032, China

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Suzhou, 215004, China

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Tianjin, 300170, China

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Wenzhou, 325000, China

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Wuhan, 430010, China

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Wuhan, 430022, China

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Xi'an, 710000, China

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Zhengzhou, 450008, China

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Zhuhai, 519000, China

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Al Mansurah, 7650001, Egypt

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Cairo, 11451, Egypt

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Shebeen El Kom, 32511, Egypt

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Angers, 49933, France

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Clichy, 92110, France

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Créteil, 94010, France

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Montpellier, 34295, France

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Nantes, 44093, France

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Nice, 06200, France

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Paris, 75013, France

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Strasbourg, 67091, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Bonn, 53127, Germany

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Chemnitz, 09116, Germany

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Dresden, 01307, Germany

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Düsseldorf, 40225, Germany

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Frankfurt, 60596, Germany

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Göttingen, 37075, Germany

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Hamburg, 22291, Germany

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Hanover, 30625, Germany

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Heidelberg, 69120, Germany

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Kiel, 24105, Germany

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Leipzig, 04103, Germany

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Magdeburg, 39120, Germany

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Ulm, 89081, Germany

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Ahmedabad, 380054, India

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Ahmedabad, 380060, India

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Bangalore, 560027, India

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Delhi, 110029, India

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Hyderabad, 500032, India

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Jaipur, 302022, India

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Kolkata, 700099, India

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Mumbai, 400012, India

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New Delhi, 110 085, India

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New Delhi, 110005, India

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Arezzo, 52100, Italy

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Florence, 50134, Italy

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Milan, 20132, Italy

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Milan, 20133, Italy

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Roma, 00128, Italy

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Rozzano, 20089, Italy

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Tricase, 73039, Italy

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Chūōku, 104-0045, Japan

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Fukuoka, 810-8563, Japan

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Hiroshima, 734-8551, Japan

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Kashihara-shi, 634-8522, Japan

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Kashiwa, 277-8577, Japan

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Kumamoto, 860-8556, Japan

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Mitaka-shi, 181-8611, Japan

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Morioka, 028-3695, Japan

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Musashino-shi, 180-8610, Japan

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Okayama, 700-8558, Japan

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Osaka, 543-8555, Japan

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Osaka, 545-8586, Japan

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Osakasayama-shi, 589-8511, Japan

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Sapporo, 006-8555, Japan

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Sendai, 981-0914, Japan

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Sunto-gun, 411-8777, Japan

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Tokushima, 770-8503, Japan

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Tsu, 514-8507, Japan

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Yokohama, 241-8515, Japan

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Bandar Puncak Alam, 42300, Malaysia

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George Town, 10450, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Kuala Selangor, 62250, Malaysia

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Kuching, 93586, Malaysia

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Guadalajara, Jalisco, 44280, Mexico

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México, 1400, Mexico

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San Luis Potosí City, 78209, Mexico

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Tuxtla Gutiérrez, 29090, Mexico

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Davao City, 8000, Philippines

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Makati, 1229, Philippines

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Manila, 1003, Philippines

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Pasig, 1600, Philippines

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Quezon City, 1112, Philippines

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Lisbon, 1649-035, Portugal

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Vila Real, 5000-508, Portugal

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Hato Rey Central, 00917, Puerto Rico

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San Juan, 00927, Puerto Rico

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Jeddah, 22384, Saudi Arabia

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Riyadh, 12713, Saudi Arabia

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Busan, 49241, South Korea

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Daegu, 42601, South Korea

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Goyang-si, 10408, South Korea

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Junggu, 41944, South Korea

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Seoul, 03080, South Korea

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Seoul, 03722, South Korea

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Seoul, 06351, South Korea

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Barcelona, 08036, Spain

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Córdoba, 14004, Spain

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Donostia / San Sebastian, 20014, Spain

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Madrid, 28007, Spain

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Madrid, 28034, Spain

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Taichung, 40447, Taiwan

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Taichung, 40705, Taiwan

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Tainan, 70403, Taiwan

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Taipei, 100, Taiwan

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Taipei, TAIWAN, Taiwan

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Taoyuan District, 333, Taiwan

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Bangkok, 10210, Thailand

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Bangkok, 10300, Thailand

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Bangkok, 10400, Thailand

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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Hat Yai, 90110, Thailand

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Khon Kaen, 40002, Thailand

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Hanoi, 100000, Vietnam

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Hà Nội, 100000, Vietnam

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Ho Chi Minh City, 700000, Vietnam

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Ho Chi Minh City, 70000, Vietnam

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MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

tremelimumab; durvalumab; lenvatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: March 28, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): February 26, 2027
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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 refer 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

Locations

BR (9); TH (7); FR (10); SA (2); ME (4); KR (7); ES (5); VN (4); CA (8); IN (10); TW (6); EG (3); MY (5); CN (29); PH (5); JP (19); PT (2); IT (7); PR (2); BE (2); DE (13); US (12)