AzTrials
AzTrials

Esophageal Squamous Cell CarcinomaPhase 3SKYSCRAPER-07NCT04543617

A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

A Phase 3 study testing Tiragolumab and Atezolizumab in people with Esophageal Squamous Cell Carcinoma, run by Hoffmann-La Roche at 166 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Tiragolumab and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
760 participants
Where
166 sitesin 28 countries
Study dates
28 Sep 2020to 22 Jul 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
  • Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist prior to dCRT and is not expected to undergo tumor resection during the course of the study
  • dCRT treatment according to regional oncology guidelines for esophageal cancer
  • Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens collected prior to initiation of dCRT
  • Adequate hematologic and end-organ function prior to randomization
  • Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
  • Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of tiragolumab/placebo.

Who cannot join

  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
  • Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
  • Prior allogeneic stem cell or solid organ transplantation
  • Active or history of autoimmune disease or immune deficiency
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
  • Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
  • Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization.

Trial locations and contacts

166 sites in 28 countries.

166 sites in 28 countries

China35 sites

  • Anyang Tumor Hosptial

    Anyang, 455000

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021

  • Affiliated Hospital of Bengbu Medical College

    Bengbu, 233004

  • Hunan Cancer Hospital

    Changsha, 410013

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, 046000

  • Changzhou Cancer hospital

    Changzhou, 213000

  • Sichuan Provincial Cancer Hospital

    Chengdu, 610041

  • West China Hospital, Sichuan University

    Chengdu, 610041

  • Chongqing Cancer Hospital

    Chongqing, 400030

  • Chongqing Sanxia Central Hospital

    Chongqing, 404000

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Sun Yet-sen University Cancer Center

    Guangzhou, 510060

  • Nanfang Hospital, Southern Medical University

    Guangzhou, 510515

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Jieyang People's Hospital

    Jieyang

  • Shandong Cancer Hospital

    Jinan, 250117

  • Affiliated Hospital of Jining Medical University

    Jining, 272029

  • The First People's Hospital of Lian Yun Gang

    Lianyungang, 222002

  • Lishui Central Hospital

    Lishui

  • The First Affiliated Hospital to Henan University of Science and Technology

    Luoyang, 471003

  • Affiliated Drum Tower Hospital of Nanjing University Medical School

    Nanjing, 210008

  • Shanghai Chest Hospital

    Shanghai, 200000

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Cancer Hospital of Shantou University Medical College

    Shantou, 515041

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042

  • Cancer Hospital Chinese Academy of Medical Sciences Shenzhen Center

    Shenzhen

  • Hebei Medical University Fourth Hospital

    Shijiazhuang, 050035

  • Tianjin Cancer Hospital

    Tianjin, 300060

  • Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430022

  • Hubei Cancer Hospital

    Wuhan, 430079

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

  • The Affiliated Hospital of Xuzhou Medical College

    Xuzhou, 221000

  • Subei People's Hospital of Jiangsu province

    Yangzhou, 225001

Other trials in China

Japan15 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • National Cancer Center Hospital East

    Chiba, 277-8577

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kobe University Hospital

    Hyōgo, 650-0017

  • Yokohama City University Medical Center

    Kanagawa, 232-0024

  • Kanagawa Cancer Center

    Kanagawa, 241-8515

  • Tohoku University Hospital

    Miyagi, 980-8574

  • Niigata Cancer Center Hospital

    Niigata, 951-8566

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • The University of Osaka Hospital

    Osaka, 565-0871

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Saitama Cancer Center

    Saitama, 362-0806

  • Shizuoka Cancer Center

    Shizuoka, 411-8777

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135-8550

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

France10 sites

  • CHRU De Brest - Hopital Morvan - Institut De Cancerologie Et D'Hematologie

    Brest, 29609

  • CHU Dijon Bourgogne Hôpital François Mitterand

    Dijon, 21000

  • Hopital Claude Huriez

    Lille, 59037

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Timone Adultes

    Marseille, 13385

  • Centre Antoine Lacassagne

    Nice, 06189

  • European Hospital Georges Pompidou (HEGP)

    Paris, 75908

  • Hopital Du Haut-Leveque

    Pessac, 33604

  • Chu La Miletrie

    Poitiers, 86021

  • Hopital Rangueil

    Toulouse, 31059

Other trials in France

Spain9 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • Hospital Universitario Reina Sofia

    Córdoba, 14004

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • Hospital Univ. Central de Asturias

    Oviedo, Principality of Asturias, 33006

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital La Fe

    Valencia

Other trials in Spain

Russia8 sites

  • City Oncological Hospital

    Izhevsk, Udmurtiya Republic, 426067

  • Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic

    Kazan', Tatarstan Republic, 420029

  • Krasnoyarsk Regional Oncology Dispensary n.a. Krizhanovsky

    Krasnoyarsk, Krasnodarskiy Kray, 660133

  • Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy

    Moscow, Moscow Oblast, 115478

  • Limited Liability Company "RC Medical"

    Novosibirsk, 630005

  • Scientific Research Institute n.a. N.N. Petrov

    Saint Petersburg, Sankt-Peterburg, 187758

  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF

    Saint Petersburg, Sankt-Peterburg, 197022

  • Regional Oncology Dispensary

    Tomsk, 634063

Other trials in Russia

Germany7 sites

  • Universitätsklinikum Essen Klinik f.Strahlentherapie

    Essen, 45122

  • Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Internistische Onkologie / Haematologie

    Essen, 45136

  • Klinik für Gastroenterologie und Gastrointestinale Onkologie der UMG

    Göttingen, 37075

  • Universitaetsklinikum Leipzig

    Leipzig, 04103

  • Med. Fak. d. Otto-von-Guericke-Universität

    Magdeburg, 39120

  • Klinikum der Philipps-Universität Marburg

    Marburg, 35032

  • Universitätsklinikum Klinik u.Poliklinik f.Strahlentherapie

    Regensburg, 93053

Other trials in Germany

South Korea7 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Ajou University Medical Center

    Gyeonggi-do, 16499

  • Chonnam National University Hwasun Hospital

    Jeollanam-do, 58128

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

Turkey (Türkiye)7 sites

  • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital

    Adana, 01250

  • Ankara University Faculty of Medicine Cebeci Hospital

    Ankara, 06700

  • Ankara City Hospital

    Ankara, 06800

  • Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

    Erzurum, 25240

  • Goztepe Prof.Dr. Suleyman Yalcin City Hospital

    Kadiköy, 34722

  • Inonu University Faculty of Medicine Turgut Ozal Medical Center

    Malatya, 44280

  • Van Yuzuncu Yil University Hospital

    Van

Other trials in Turkey (Türkiye)

Poland6 sites

  • Centrum Onkologii

    Bydgoszcz, 85-796

  • Centrum Onkologii Ziemi Lubelskiej Im. ?W. Jana Z Dukli

    Lublin, 20-090

  • Szpital Kliniczny MSWiA z Warmi?sko-Mazurskim Centrum Onkologii

    Olsztyn, 10-228

  • Wielkopolskie Centrum Onkologii im. Marii Sk?odowskiej-Curie

    Późna, 61-866

  • NIO im Marii Sklodowskiej-Curie

    Warsaw, 02-034

  • Dolno?l?skie Centrum Onkologii

    Wroc?aw, 53-413

Other trials in Poland

Taiwan6 sites

  • Chang Gung Medical Foundation - Kaohsiung;Oncology

    Kaohisung

  • China Medical University Hospital

    Taichung, 404

  • National Cheng Kung University Hospital

    Tainan, 00704

  • Chi-Mei Medical Centre

    Tainan, 710

  • National Taiwan University Hospital

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 112201

Other trials in Taiwan

United Kingdom6 sites

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Ninewells Hospital

    London, DD1 9SY

  • Royal Marsden Hospital - Fulham

    London, SW3 6JJ

  • Clatterbridge Cancer Centre

    Metropolitan Borough of Wirral, CH63 4JY

  • Royal Marsden Hospital (Sutton)

    Sutton, SM2 5PT

Other trials in United Kingdom

Austria4 sites

  • Tiroler Landeskrankenanstalten Ges.M.B.H.

    Innsbruck, 6020

  • Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020

  • Ordensklinikum Linz Barmherzige Schwestern

    Linz, 4010

  • AKH - Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Italy4 sites

  • Ospedale Degli Infermi - Faenza

    Faenza, Emilia-Romagna, 48018

  • Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80131

  • Istituto Oncologico Veneto IRCCS

    Padova, Veneto, 35128

  • Asu Fc S. M. Della Misericordia

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Thailand4 sites

  • Vajira Hospital

    Bangkok, 10300

  • Chulalongkorn Hospital

    Bangkok, 10330

  • Ramathibodi Hospital

    Bangkok, 10400

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Ukraine4 sites

  • Municipal Noncommercial Institution Regional Center of Oncology

    Kharkiv, Kharkiv Governorate, 61070

  • RCI Sumy Regional Clinical Oncological Dispensary

    Sumy, 40005

  • Vinnytsya Regional Clinical Oncology Dispensary

    Vinnytsia, Podolia Governorate, 21029

  • Zhytomyr Regional Oncology Center

    Zhytomyr, KIEV Governorate

Other trials in Ukraine

United States3 sites

  • Florida Cancer Specialists - Fort Myers (Broadway)

    Fort Myers, Florida, 33901

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728

  • Great Lakes Cancer Center

    Williamsville, New York, 14221

Other trials in United States

Argentina3 sites

  • Instituto de Investigaciones Metabolicas (Idim)

    Buenos Aires, C1012AAR

  • Fundacion Favaloro

    Buenos Aires, C1093AAS

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

Other trials in Argentina

Australia3 sites

  • Austin Health

    Heidelberg, Victoria, 3084

  • St John of God Hospital

    Subiaco, Western Australia, 6008

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Belgium3 sites

  • UZ Antwerpen

    Edegem, 2650

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • CHU de Liège (Sart Tilman)

    Liège, 4000

Other trials in Belgium

Greece3 sites

  • Evgenidio Hospital "Agia Trias"

    Athens, 115 28

  • Univ General Hosp Heraklion

    Heraklion, 711 10

  • Euromedical General Clinic of Thessaloniki

    Thessaloniki, 546 45

Other trials in Greece

Israel3 sites

  • Hadassah Ein Karem Hospital

    Jerusalem, 9112000

  • Rambam Health Corporation

    Rambam, 3525408

  • Tel Aviv Sourasky Medical Ctr

    Tel Aviv, 6423906

Other trials in Israel

Morocco3 sites

  • Centre Hospitalier Universitaire Hassan II

    Fes, 30000

  • Centre Hospitalier Universitaire Mohamed VI

    Marrakesh, 40000

  • Institut National D'oncologie Sidi Med Benabdellah

    Rabat, 10100

Other trials in Morocco

Portugal3 sites

  • HUC

    Coimbra, 3000-075

  • Centro Hospitalar do Porto ? Hospital de Santo António

    Porto, 4099-001

  • IPO do Porto

    Porto, 4200-072

Other trials in Portugal

South Africa3 sites

  • Limpopo Cancer Research Institute

    Polokwane

  • Cancercare

    Port Elizabeth, 6045

  • Eugene Marais Hospital

    Pretoria

Other trials in South Africa

Hungary2 sites

  • Pécsi Tudományegyetem

    Pécs, 7623

  • Szegedi Tudományegyetem

    Szeged, 6720

Other trials in Hungary

Kenya2 sites

  • International Cancer Institute (ICI)

    Eldoret, 30100

  • The Aga Khan University-Kenya.

    Nairobi, 00100

Other trials in Kenya

Switzerland2 sites

  • Inselspital Bern, Insel-Gruppe AG

    Bern, 3010

  • UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

New Zealand1 site

  • Tauranga Hospital, Clinical Trials Unit

    Tauranga, 3112

Other trials in New Zealand

About this study

Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab With or Without Tiragolumab (Anti-TIGIT Antibody) in Patients With Unresectable Esophageal Squamous Cell Carcinoma Whose Cancers Have Not Progressed Following Definitive Concurrent Chemoradiotherapy

The purpose of this study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo in participants with unresectable esophageal squamous cell carcinoma (or those who are unable or unwilling to undergo surgery) and whose cancers have not progressed following definitive concurrent chemoradiotherapy (dCRT). Participants will be randomized in a 1:1:1 ratio to receive either tiragolumab plus atezolizumab (Arm A), tiragolumab matching placebo plus atezolizumab (Arm B), or double placebo (Arm C).

Being tested
Tiragolumab, Atezolizumab, Tiragolumab Matching Placebo, Atezolizumab Matching Placebo
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • TiragolumabDrug

    Also called MTIG7192A, RO7092284

    Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

  • AtezolizumabDrug

    Also called Tecentriq, RO5541267

    Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.

  • Tiragolumab Matching PlaceboDrug

    Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

  • Atezolizumab Matching PlaceboDrug

    Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.

Study groups in NCT04543617
Study groupRoleWhat they receive
Arm A: Tiragolumab + AtezolizumabExperimentalParticipants will receive atezolizumab followed by tiragolumab.
Receives: Drug: Tiragolumab; Drug: Atezolizumab
Arm B: Tiragolumab Placebo + AtezolizumabExperimentalParticipants will receive atezolizumab followed by tiragolumab matching placebo.
Receives: Drug: Atezolizumab; Drug: Tiragolumab Matching Placebo
Arm C: Tiragolumab Placebo + Atezolizumab PlaceboPlacebo comparatorParticipants will receive matching placebos to tiragolumab and atezolizumab.
Receives: Drug: Tiragolumab Matching Placebo; Drug: Atezolizumab Matching Placebo

What is being measured

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

  1. Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS)

    Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)

  2. Arm A vs Arm C: Overall Survival (OS)

    Measured: From randomization to death from any cause (up to approximately 6 years)

  3. Arm B vs Arm C: OS

    Measured: From randomization to death from any cause (up to approximately 6 years)

Secondary outcomes (15)

  1. Arm B vs Arm C: Investigator-Assessed PFS

    Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)

  2. Arm A vs Arm B: Investigator-Assessed PFS

    Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)

  3. Arm A vs Arm B: OS

    Measured: From randomization to death from any cause (up to approximately 6 years)

  4. Independent Review Facility (IRF)-Assessed PFS

    Measured: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)

  5. Investigator-Assessed Confirmed Objective Response Rate (ORR)

    Measured: From randomization up to approximately 6 years

  6. IRF-Assessed Confirmed ORR

    Measured: From randomization up to approximately 6 years

  7. Investigator-Assessed Duration of Objective Response (DOR)

    Measured: From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)

  8. IRF-Assessed DOR

    Measured: From the first occurrence of a documented confirmed objective response to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)

  9. Percentage of Participants With Clinically Meaningful Changes in Physical Functioning, Role Functioning, Quality of Life (QoL) as Measured by EORTC QLQ-C30

    Clinically meaningful changes in physical functioning, role functioning, global health status (GHS)/QoL as measured by the European Organisation for Research and Treatment of Cancer Quality of Life-Core 30 Questionnaire (EORTC QLQ-C30). EORTC QLQ-C30 is a self-reported measure, consisting of 30 questions that assess 5 aspects of participants functioning (physical, emotional, role, cognitive and social), 3 symptom scales (fatigue, nausea and vomiting, and pain), GHS and QoL, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties) within the previous week. Functioning and symptoms items are scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. GHS and QoL items are scored on a 7-point scale: 1=Very poor, 2, 3, 4, 5, 6, 7=Excellent. Scores will be linearly transformed to a range of 0 to 100, with higher scores (i.e. closer to 100) reflecting better functioning, better GHS/QoL, and worse symptoms.

    Measured: Up to approximately 6 years

  10. Percentage of Participants With Clinically Meaningful Changes in Dysphagia as Measured by EORTC QLQ-OES18

    Clinically meaningful changes in dysphagia as measured by the EORTC Quality of Life-Esophageal Cancer, Module 18 Questionnaire (EORTC QLQ-OES18). EORTC QLQ-OES18 is a modular supplement to the EORTC QLQ-C30 questionnaire for use in participants with esophageal cancer. EORTC QLQ-OES18 consists of 4 multiple-item scale (dysphagia, eating, reflux, and pain) and 6 single items (trouble swallowing saliva, choked when swallowing, dry mouth, trouble with taste, trouble with coughing, and trouble talking) with a recall period of the previous week. Each symptom item is scored on a 4-point scale: 1=Not at all, 2=A little, 3=Quite a bit, 4=Very much. Scores will be linearly transformed to a range of 0 to 100, with higher transformed scores (i.e. closer to 100) reflecting worse symptoms.

    Measured: Up to approximately 6 years

  11. Percentage of Participants With Adverse Events (AEs)

    Measured: Up to approximately 6 years

  12. Serum Concentration of Tiragolumab

    Measured: Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at treatment discontinuation (TD) visit (up to approximately 6 years)

  13. Serum Concentration of Atezolizumab

    Measured: Predose and postdose on Day 1 of Cycle 1 (each cycle=21 days) and predose on Day 1 of Cycles 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)

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

    Measured: Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)

  15. Percentage of Participants With ADAs to Atezolizumab

    Measured: Predose on Day 1 of Cycles (each cycle=21 days) 1, 2, 3, 4, 8, 12 and 16 and at TD visit (up to approximately 6 years)

Timeline

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

  1. First posted10 Sep 2020
  2. Study start28 Sep 2020
  3. Primary completion22 Jul 2026
  4. Study completion22 Jul 2026

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
760 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04543617
Sponsor's protocol ID
YO42137
Other IDs
2020-001178-31
Acronym
SKYSCRAPER-07
Status last verified
Sep 2026
First submitted
3 Sep 2020
Last updated
14 Sep 2026
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

  • Xu RH, Cho BC, Chen M, Muro K, Wyrwicz L, Li B, Gao S, Hsu C, Turpin A, Lordick F, Cha E, Wu Q, Kim S, Cai J, Zhang L, Fan J, Wang L, Sully K, Wang L, Goodman K, Shah MA, Chau I. Atezolizumab with or without tiragolumab in unresectable esophageal squamous cell carcinoma following definitive concurrent chemoradiotherapy (SKYSCRAPER-07): a randomised, phase III study. Ann Oncol. 2026 Aug 21:S0923-7534(26)01431-6. doi: 10.1016/j.annonc.2026.07.413. Online ahead of print.

    PubMed 42628839

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tiragolumab and Atezolizumab in people with Esophageal Squamous Cell Carcinoma, run by Hoffmann-La Roche at 166 sites in 28 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 7 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: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 166 sites in China, Japan, France, Spain, Russia and 23 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Arm A vs Arm C: Investigator-Assessed Progression-Free Survival (PFS) (time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 6 years)). The study lists 3 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 NCT04543617, 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 14 Sep 2026.

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