AzTrials
AzTrials

Hepatocellular CarcinomaPhase 3SKYSCRAPER-14NCT05904886

A Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Participants With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma (HCC) (IMbrave152)

A Phase 3 study testing Atezolizumab, Bevacizumab and Tiragolumab in people with Hepatocellular Carcinoma, run by Hoffmann-La Roche at 171 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic HCC. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
Atezolizumab, Bevacizumab and Tiragolumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
687 participants
Where
171 sitesin 27 countries
Study dates
14 Sep 2023to 1 Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced or metastatic and/or unresectable HCC with diagnosis confirmed by histology/cytology or clinically by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic participants
  • Disease that is not amenable to curative surgical and/or locoregional therapies
  • No prior systemic treatment for locally advanced or metastatic and/or unresectable HCC-measurable disease according to RECIST v1.1
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1 within 7 days prior to randomization
  • Child-pugh Class A within 7 days prior to randomization
  • Adequate hematologic and end-organ function
  • Female participants of childbearing potential must be willing to avoid pregnancy within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
  • Male participants with a female partner of childbearing potential or pregnant female partner must remain abstinent or use a condom during the treatment period and for 6 months after the final dose of bevacizumab and for 90 days after the final dose of tiragolumab/placebo to avoid exposing the embryo.

Who cannot join

  • Pregnancy or breastfeeding within 5 months after the final dose of atezolizumab, within 6 months after the final dose of bevacizumab, and within 90 days after the final dose of tiragolumab/placebo
  • Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Treatment with locoregional therapy to liver within 28 days prior to initiation of study treatment, or non-recovery from side effects of any such procedure
  • Treatment with systemic immunostimulatory agents
  • Treatment with systemic immunosuppressive medication
Show all 15Show fewer
  • Untreated or incompletely treated esophageal and/or gastric varices with bleeding or that are at high risk for bleeding
  • A prior bleeding event due to esophageal and/or gastric varices within 6 months prior to initiation of study treatment
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Mixed histology or other subtypes/variants of HCC, including, but not limited to, known liver adenocarcinoma, fibrolamellar HCC, sarcomatoid HCC, other rare HCC variant, or mixed cholangiocarcinoma and HCC
  • Co-infection with hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Acute epstein-barr virus (EBV) infection or known or suspected chronic active EBV infection
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Trial locations and contacts

171 sites in 27 countries.

171 sites in 27 countries

United States34 sites

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

  • University of Illinois

    Chicago, Illinois, 60612

  • UCSF Fresno at Community Cancer Institute

    Clovis, California, 93611

  • North Texas VA Medical Center

    Dallas, Texas, 75216

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • City of Hope Cancer Center

    Duarte, California, 91010

  • Florida Cancer Specialists - Fort Myers (Broadway)

    Fort Myers, Florida, 33901

  • Cancer & Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • Hartford Healthcare Cancer Institute at Hartford Hospital

    Hartford, Connecticut, 06106

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Kelsey Seybold Clnic

    Houston, Texas, 77005

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92037

  • University of Southern California

    Los Angeles, California, 90033

  • Norton Cancer Institute - Audubon

    Louisville, Kentucky, 40217

  • Univ of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Miami VA Healthcare System

    Miami, Florida, 33125

  • Ochsner Cancer Inst.

    New Orleans, Louisiana, 70121

  • NYU Langone

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032-3725

  • Stanford Cancer Center

    Palo Alto, California, 94304

  • Va Palo Alto Health Care System

    Palo Alto, California, 94304

  • Thomas Jefferson Uni

    Philadelphia, Pennsylvania, 19107

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • UCLA Cancer Center

    Santa Monica, California, 90404

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Swedish Cancer Inst.

    Seattle, Washington, 98104

  • Washington Uni School of Medicine

    St Louis, Missouri, 63110

  • Florida Cancer Specialist, North Region

    St. Petersburg, Florida, 33705

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • James J Peters VA Hospital / Mental Illness Research Education and Clinic Center

    The Bronx, New York, 10468

  • MedStar Washington Hosp Center

    Washington D.C., District of Columbia, 20010

  • Minnesota Oncology Hematology Woodbury

    Woodbury, Minnesota, 55125

Other trials in United States

China22 sites

  • Baoji Central Hospital

    Baoji, 721008

  • Beijing Cancer Hospital

    Beijing, 100142

  • The First Hospital of Jilin University

    Changchun, 130021

  • Peoples Hospital of Hunan Province

    Changsha, 410007

  • Hunan Cancer Hospital

    Changsha, 410013

  • West China Hospital - Sichuan University

    Chengdu, 610047

  • Mengchao Hepatobiliary Hospital Of Fujian Medical University

    Fuzhou, 350025

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • Sun yat-sen University Cancer Center

    Guangzhou

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou, 310003

  • Zhejiang Provincial People?s Hospital

    Hangzhou, 310014

  • Harbin Medical University Cancer Hospital

    Harbin, 150081

  • Anhui Provincial Hospital

    Hefei, 230001

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, 230601

  • Lishui Central Hospital

    Lishui, 323000

  • Zhongshan Hospital Fudan Unvierstiy

    Shanghai, 200032

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai, 200127

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

  • Xi'an Inernational Medical Center Hospital

    Xi'an, 710119

Other trials in China

Japan20 sites

  • Fujita Health University Hospital

    Aichi, 470-1192

  • Chiba University Hospital

    Chiba, 260-8677

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Ehime Prefectural Central Hospital

    Ehime, 790-0024

  • Kurume University Hospital

    Fukuoka, 830-0011

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Sapporo Kosei General Hospital

    Hokkaido, 060-0033

  • Hokkaido University Hospital

    Hokkaido, 060-8648

  • Kanazawa University Hospital

    Ishikawa, 920-8641

  • Toranomon Branch Hospital

    Kanagawa, 213-8587

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Kitasato University Hospital

    Kanagawa, 252-0375

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Kyoto University Hospital

    Kyoto, 606-8507

  • Iwate Medical University Hospital

    Numakunai, 028-3695

  • The University of Osaka Hospital

    Osaka, 565-0871

  • Kindai University Hospital

    Osaka, 589-8511

  • Jichi Medical University Hospital

    Tochigi, 329-0498

  • Toranomon Hospital

    Tokyo, 105-8470

  • Japanese Red Cross Musashino Hospital

    Tokyo, 180-8610

Other trials in Japan

Spain11 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Duran i Reynals

    Barcelona, 08907

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Clinica Universitaria de Navarra de Madrid;Servicio de Hepatologia

    Madrid, 28027

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Madrid, 28222

  • Hospital de Navarra

    Navarra, Navarre, 31008

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Clinica Universitaria de Navarra

    Pamplona/iruña, Navarre, 31008

  • Hospital Clinico de Valencia

    Valencia, 46010

Other trials in Spain

France10 sites

  • CHU CAEN - Hôpital de la Côte de Nacre

    Caen, 14033

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037

  • Hopital Dupuytren

    Limoges, 87042

  • Fondation Hopital Saint Joseph

    Marseille, 13285

  • Hopital Hotel Dieu Et Hme

    Nantes, 44093

  • APHP - Hopital Saint Antoine

    Paris, 75571

  • Hopital Robert Debre

    Reims, 51092

  • Centre Hospitalier Valence

    Valence, 26953

  • Hopitaux de Brabois - Gastro-Entereologie

    Vandœuvre-lès-Nancy, 54511

  • Hopital Paul Brousse

    Villejuif, 94804

Other trials in France

Brazil8 sites

  • Hospital de Cancer de Barretos

    Barretos, São Paulo, 14784-400

  • Oncoclínicas do Brasil - BELO HORIZONTE

    Belo Horizonte, Minas Gerais, 30170-080

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000

  • Clinicas Oncologicas Integradas - COI

    Rio de Janeiro, 22290-160

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • CEDOES - Diagnóstico e Pesquisa

    Vitória, Espírito Santo, 29055-450

Other trials in Brazil

South Korea8 sites

  • National Cancer Center

    Goyang-si, 10408

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Severance Hospital, Yonsei University Health System

    Seoul, 003-722

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Ulsan University Hosiptal

    Ulsan, 44033

Other trials in South Korea

Italy7 sites

  • A.O. S. Orsola Malpighi

    Bologna, Emilia-Romagna, 40138

  • Az. Osp. Uni Ria San Martino

    Genoa, Liguria, 16132

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, Lazio, 00168

  • IRCCS Istituto Clinico Humanitas

    Rozzano, Lombardy, 20089

  • Az. Osp. G. Panico

    Tricase, Apulia

  • A.O.U.I. Verona-Ospedale Policlinico G.B. Rossi Borgo Roma

    Verona, Veneto, 37134

Other trials in Italy

Taiwan5 sites

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung University Hospital

    Tainan, 00704

  • Chi-Mei Medical Centre

    Tainan, 710

  • National Taiwan Uni Hospital

    Taipei, 100

  • Chang Gung Medical Foundation - Linkou

    Taoyuan, 333

Other trials in Taiwan

Turkey (Türkiye)5 sites

  • Adana Baskent University Medical Faculty

    Adana, 01220

  • Ankara Bilkent City Hospital

    Ankara, 06490

  • Gazi Uni Medical Faculty Hospital

    Ankara, 06500

  • Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

    Edirne, 22030

  • ?zmir Medical Point

    Kar?iyaka, 35575

Other trials in Turkey (Türkiye)

Canada4 sites

  • Juravinski Hospital

    Hamilton, Ontario, L8V 1C3

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Germany4 sites

  • Klinikum Esslingen

    Esslingen am Neckar, 73730

  • Universitätsklinikum Magdeburg Klinik für Gastroenterologie und Hepatologie

    Magdeburg, 39120

  • Uniklinik Mainz

    Mainz, 55131

  • Universität Tübingen

    Tübingen, 72076

Other trials in Germany

Mexico4 sites

  • OncoMed

    Mexico City, Mexico CITY (federal District), 03100

  • Centro Medico Nacional Siglo Xxi - Imss

    Mexico City, Mexico CITY (federal District), 06720

  • Instituto Nacional de Ciencias Médicas Y de Nutricion Salvador Zubirán

    Mexico City, Mexico CITY (federal District), 14000

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

Other trials in Mexico

Thailand4 sites

  • Chulalongkorn Hospital

    Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, 10400

  • Maharaj Nakorn Chiang Mai Hospital

    Chiang Mai, 50200

  • Khon Kaen Uni

    Khon Kaen, 40002

Other trials in Thailand

Belgium3 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

Other trials in Belgium

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1023

  • Christchurch Hospital

    Christchurch, 8011

  • Wellington Hospital

    Wellington, 6021

Other trials in New Zealand

United Kingdom3 sites

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Royal Free Hospital

    London, NW3 2QG

  • Hammersmith Hospital

    London, W12 0HS

Other trials in United Kingdom

Côte d’Ivoire2 sites

  • Polyclinique Internationale Sainte Anne- Marie (PISAM)

    Abidjan, BP 1463 Abidjan

  • Centre National d'Oncologie Médicale et de Radiothérapie Alassane Ouattara (CNRAO)

    Abidjan

Other trials in Côte d’Ivoire

Ghana2 sites

  • KBTH

    Accra, 0000

  • Sweden Ghana Medical Center

    Accra

Other trials in Ghana

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Prince of Wales Hosp

    Shatin

Other trials in Hong Kong

Nigeria2 sites

  • Jos University Teaching Hospital

    Jos, 930232

  • Lagos University Teaching Hospital Lagos (LUTH), Lagos State

    Lagos

Other trials in Nigeria

Poland2 sites

  • ID Clinic

    Mysłowice, 41-400

  • NIO im Marii Sklodowskiej-Curie

    Warsaw, 02-034

Other trials in Poland

South Africa2 sites

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, 2193

  • Limpopo Cancer Research Institute

    Polokwane, 0700

Other trials in South Africa

Kenya1 site

  • University of Nairobi - Institute of Tropical and Infectious Diseases

    Nairobi

Other trials in Kenya

Puerto Rico1 site

  • PanOncology Trials

    San Juan, 00935

Other trials in Puerto Rico

Singapore1 site

  • National Cancer Centre

    Singapore, 168583

Other trials in Singapore

Uganda1 site

  • Uganda Cancer Institute

    Kampala

Other trials in Uganda

About this study

Official title: A Phase III, Randomized, Double-blind, Placebo-controlled Study Evaluating Atezolizumab and Bevacizumab, With or Without Tiragolumab, in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma

The purpose of this study is to assess the efficacy and safety of tiragolumab, an anti-TIGIT monoclonal antibody, when administered in combination with atezolizumab and bevacizumab as first-line treatment, in participants with unresectable, locally advanced or metastatic HCC.

Per amendment version 5, following a memo issued by the Sponsor, participants receiving treatment in the atezolizumab plus bevacizumab plus tiragolumab arm are recommended to discontinue tiragolumab treatment unless the investigator decides the benefit outweighs the risk. Participants receiving treatment in atezolizumab plus bevacizumab plus placebo arm must discontinue placebo treatment. Participants may continue receiving active treatment(s) per protocol until loss of clinical benefit or unacceptable toxicity, whichever occurs first.

Being tested
Atezolizumab, Bevacizumab, Tiragolumab, Placebo
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabDrug

    Also called Tecentriq; MPDL3280A; RO5541267

    Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab will be administered by IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle.

  • TiragolumabDrug

    Also called MTIG7192A; RO7092284

    Tiragolumab will be administered by IV infusion at a fixed dose of 600 mg on Day 1 of each 21-day cycle.

  • PlaceboOther

    Placebo matching tiragolumab will be administered by IV infusion on Day 1 of each 21-day cycle.

Study groups in NCT05904886
Study groupRoleWhat they receive
Atezolizumab + Bevacizumab + TiragolumabExperimentalAtezolizumab plus bevacizumab plus tiragolumab will be administered every 3 weeks (Q3W) until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Drug: Tiragolumab
Atezolizumab + Bevacizumab + PlaceboPlacebo comparatorAtezolizumab, bevacizumab plus placebo will be administered Q3W until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
Receives: Drug: Atezolizumab; Drug: Bevacizumab; Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-assessed Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

    Measured: From randomization to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first (up to approximately 21 months)

  2. Overall Survival (OS)

    Measured: From randomization to death from any cause (up to approximately 36 months)

Secondary outcomes (14)

  1. Investigator-assessed Confirmed Objective Response Rate (ORR) According to RECIST v1.1

    Measured: From randomization up to approximately 21 months

  2. Investigator-assessed Duration of Response (DOR) According to RECIST v1.1

    Measured: From the first occurrence of a documented confirmed objective response to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months)

  3. Investigator-assessed PFS Rate According to RECIST v1.1 at 6 and 12 Months

    Measured: Month 6, Month 12

  4. OS Rate at 1 and 2 Years

    Measured: Year 1, Year 2

  5. Investigator-assessed PFS According to HCC mRECIST

    Measured: From randomization to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months)

  6. Investigator-assessed Confirmed ORR According to HCC mRECIST

    Measured: From randomization up to approximately 21 months

  7. Investigator-assessed DOR According to HCC mRECIST

    Measured: From the first occurrence of a documented confirmed objective response to the first occurrence of PD or death from any cause, whichever occurs first (up to approximately 21 months)

  8. Time to Confirmed Deterioration (TTCD) Assessed Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer 30 (EORTC QLQ-C30) Subscales

    The following subscales of the EORTC QLQ-C30 will be used for the assessment: global health status/quality-of-life (GHS/QoL), physical functioning and role functioning. GHS and QoL are scored on a 7-point scale: 1=Very poor to 7=Excellent. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with a higher score indicating a worse outcome. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. A higher score indicates a better outcome.

    Measured: Up to approximately 21 months

  9. Change from Baseline in GHS/QoL, Physical Functioning, and Role Functioning Assessed Using the EORTC QLQ-C30

    GHS and QoL are scored on a 7-point scale: 1=Very poor to 7=Excellent. Functioning items are scored on a 4-point scale: 1=Not at all to 4=Very much, with a higher score indicating a worse outcome. Scores will be linearly transformed with a minimum score of 0 and maximum score of 100. A higher score indicates a better outcome.

    Measured: Up to approximately 21 months

  10. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to approximately 36 months

  11. Serum Concentrations of Atezolizumab

    Measured: Prior to the first infusion and 30 minutes after atezolizumab infusion on Day 1 of Cycle 1 (cycle = 21 days), prior to infusion on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months)

  12. Serum Concentrations of Tiragolumab

    Measured: Prior to the first infusion and 30 minutes after tiragolumab infusion on Day 1 of Cycle 1 (cycle = 21 days), prior to infusion on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months)

  13. Percentage of Participants With Anti-drug Antibodies (ADAs) to Tiragolumab

    Measured: Prior to the first infusion on Day 1 of Cycles (cycle = 21 days) 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months)

  14. Percentage of Participants With ADAs to Atezolizumab

    Measured: Prior to the first infusion on Day 1 of Cycles (cycle = 21 days) 1, 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit (up to approximately 21 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start14 Sep 2023
  3. Primary completion8 May 2025
  4. Study completion1 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
687 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05904886
Sponsor's protocol ID
CO44668
Other IDs
2023-503422-39-00, 2023
Acronym
SKYSCRAPER-14
Status last verified
Dec 2025
First submitted
23 May 2023
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing

Publications

  • Badhrinarayanan S, Cotter C, Zhu H, Lin YC, Kudo M, Li D. IMbrave152/SKYSCRAPER-14: a Phase III study of atezolizumab, bevacizumab and tiragolumab in advanced hepatocellular carcinoma. Future Oncol. 2024;20(28):2049-2057. doi: 10.1080/14796694.2024.2355863. Epub 2024 Jun 10.

    PubMed 38861301

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atezolizumab, Bevacizumab and Tiragolumab in people with Hepatocellular Carcinoma, run by Hoffmann-La Roche at 171 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 171 sites in United States, China, Japan, Spain, France and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-assessed Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) (time frame: From randomization to the first occurrence of disease progression (PD) or death from any cause, whichever occurs first (up to approximately 21 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05904886, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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