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A clinical trial to evaluate the safety and effectiveness of atezolizumab with or without tiragolumab versus placebo in people with squamous cell esophageal cancer that cannot be surgically removed and has not got worse after prior chemoradiotherapy (SKYSCRAPER-07)
A Study of Atezolizumab With or Without Tiragolumab in Participants With Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
- Cancer
- Esophageal Squamous Cell Carcinoma
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Active, not recruiting
This trial runs in
Cities
- _
- A Coruña
- aaq
- ABD
- Adana
- an-yang-shi
- Ankara
- Anyang
- Athens
- Bangkok
- Barcelona
- bei-jing-shi
- belbeze-en-comminges
- beng-bu-shi
- Berea
- Bern
- Bournemouth
- Brest
- Buenos Aires
- Bydgoszcz
- Cambridge
- chang-sha-shi
- chang-zhi-shi
- chang-zhou-shi
- Changzhou Shi
- cheng-du-shi
- Chengdu
- chong-qing-shi
- Chongqing
- Christchurch
- Coimbra
- Corona
- Córdoba
- Daegu
- Dijon
- Dundee
- Edegem
- Eldoret
- Erzurum
- Essen
- Faenza
- Fes
- Fort Myers
- fu-zhou-shi
- Fuzhou
- Gaziantep
- gqeberha
- guang-zhou-shi
- Gwangju
- Győr
- Göttingen
- hang-zhou-shi
- Heidelberg
- Hidaka
- Hiroshima
- Houston
- Ina
- Innsbruck
- Iraklio
- İstanbul
- izhevsk
- Jerusalem
- Ji Nan Shi
- jie-yang-shi
- Jinan
- Jining
- Johannesburg
- Kaohsiung City
- Kashiwa
- Kazan
- Kharkiv
- Kho Hong
- Klagenfurt am Wörthersee
- Kobe
- Koto City
- Krasnoyarsk
- Krung Thep Maha Nakhon
- Kwangju
- La Rioja
- Leipzig
- Leuven
- li-shui-shi
- lian-yun-gang-shi
- Lille
- Linz
- Liège
- London
- Lublin
- luik
- Luo Yang Shi
- Lyon
- Madrid
- Magdeburg
- Malatya
- Marburg
- Marrakech
- Marrakesh
- Marseille
- Milano
- Moscow
- Moscow Oblast
- Málaga
- Nagaizumi
- Nagoya
- Nairobi
- nan-jing-shi
- Nanjing
- Napoli
- New York
- Nice
- Niigata
- Novosibirsk
- Olsztyn
- Osaka
- Oviedo
- Padova
- Paris
- Pessac
- Philadelphia
- Poitiers
- Polokwane
- Porto
- Poznań
- Pretoria
- Pécs
- Rabat
- Regensburg
- Reggio Emilia
- Riverside
- Saint Petersburg
- Sankt-Peterburg
- segrate
- Sendai
- Seoul
- shan-tou-shi
- shang-hai-shi
- Shanghai
- shen-yang-shi
- Shenzhen
- shi-jia-zhuang-shi
- Shijiazhuang
- Shinjuku City
- St. Louis
- St. Petersburg
- Subiaco
- Suita
- Sumy
- Sutton
- Suwon
- Suwon-si
- Swansea
- Szeged
- Taichung City
- Tainan City
- Taipei City
- tambon-kho-hong
- Tauranga
- Tel Aviv-Yafo
- Thessaloniki
- tian-jin-shi
- Tomsk
- Toulouse
- Udine
- València
- Van
- Vienna
- Vinnytsia
- Warszawa
- Wichita
- Wien
- Williamsville
- Wirral
- Wolverhampton
- Woolloongabba
- Wrocław
- wu-han-shi
- xia-men-shi
- Xiamen
- xin-xiang-shi
- xu-zhou-shi
- Xuzhou
- yang-zhou-shi
- Yangzhou
- Yokohama
- Zhytomyr
- Zürich
- กรุงเทพมหานคร
- 横浜市
Trial Identifier:
NCT04543617 2020-001178-31 YO42137
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 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).
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04543617,YO42137,2020-001178-31
Trial Identifier
Tiragolumab, Atezolizumab, Tiragolumab Matching Placebo, Atezolizumab Matching Placebo
Treatments
Esophageal Squamous Cell Carcinoma
Condition
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
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
For the latest version of this information please go to www.forpatients.roche.com