A Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Participants With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Carcinoma
SKYSCRAPER-08
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Patients With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma
1 other identifier
interventional
461
5 countries
68
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of atezolizumab plus tiragolumab in combination with paclitaxel and cisplatin (PC) compared with atezolizumab matching placebo plus tiragolumab matching placebo plus PC as first-line treatment in participants with unresectable locally advanced, unresectable recurrent, or metastatic esophageal carcinoma (EC). Participants will be randomized in a 1:1 ratio to receive one of the following treatment regimens during induction phase: Arm A: Atezolizumab plus Tiragolumab and PC Arm B: Atezolizumab placebo plus Tiragolumab placebo and PC Following the induction phase, participants will continue maintenance therapy with either atezolizumab plus tiragolumab (Arm A) or atezolizumab matching placebo plus tiragolumab matching placebo (Arm B).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2020
Longer than P75 for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 3, 2020
CompletedFirst Posted
Study publicly available on registry
September 7, 2020
CompletedStudy Start
First participant enrolled
October 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2025
CompletedResults Posted
Study results publicly available
April 9, 2026
CompletedApril 9, 2026
March 1, 2026
2.3 years
September 3, 2020
February 6, 2026
March 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Independent Review Facility (IRF)-Assessed Progression-Free Survival (PFS)
PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) or death from any cause (whichever occurred first), as determined by an IRF according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum of diameters on study (including baseline). In addition to the relative increase of 20%, the sum of diameters must also demonstrate an absolute increase of \>/= 5 millimeters (mm).
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)
Overall Survival (OS)
OS was defined as the time from randomization to death from any cause.
From randomization to death from any cause (up to approximately 27 months)
Secondary Outcomes (16)
Investigator-Assessed PFS
From randomization to the first occurrence of disease progression or death from any cause, whichever occurs first (up to approximately 19 months)
IRF-Assessed Confirmed Objective Response Rate (ORR)
From randomization up to approximately 19 months
Investigator-Assessed Confirmed ORR
From randomization up to approximately 19 months
IRF-Assessed Duration of Objective Response (DOR)
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 19 months)
Investigator-Assessed DOR
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 19 months)
- +11 more secondary outcomes
Study Arms (2)
Atezolizumab + Tiragolumab + PC
EXPERIMENTALParticipants will receive atezolizumab and tiragolumab on Day 1 of each 21-day cycle during the study followed by paclitaxel and cisplatin on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the induction treatment phase.
Placebo + PC
PLACEBO COMPARATORParticipants will receive atezolizumab matching placebo and tiragolumab matching placebo on Day 1 of each 21-day cycle during the study followed by paclitaxel and cisplatin on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit or unacceptable toxicity, during the induction treatment phase.
Interventions
Atezolizumab at a fixed dose of 1200 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
Tiragolumab at a fixed dose of 600 mg administered by IV infusion every Q3W on Day 1 of each 21-day cycle.
Paclitaxel 175 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
Cisplatin 60-80 mg/m\^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
Atezolizumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Tiragolumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
Eligibility Criteria
You may qualify if:
- Histologically confirmed EC
- Unresectable locally advanced, unresectable recurrent, or metastatic disease
- Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic and end-organ function
- Female participants must be willing to avoid pregnancy and refrain from donating eggs during the treatment period and for 90 days after the final dose
- Male participants with partners of childbearing potential must commit to the use of two methods of contraception and must not donate sperm for the study duration and 90 days after the final dose
You may not qualify if:
- Palliative radiation treatment for EC within 4 weeks prior to initiation of study treatment
- Evidence of complete esophageal obstruction not amenable to treatment
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Uncontrolled tumor-related pain, uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Active or history of autoimmune disease or immune deficiency or leptomeningeal disease
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
- Malignancies other than EC within 2 years prior to screening with a negligible risk of metastasis or death adequately treated with expected curative outcome
- Severe infection within 4 weeks prior to initiation of study treatment or any active infection that, in the opinion of the investigator, could impact patient safety
- Positive test result for human immunodeficiency virus (HIV)
- Active hepatitis B or hepatitis C
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-CTLA-4, anti-TIGIT, anti-PD-1, and anti-PD-L1 therapeutic antibodies
- Treatment with any investigational therapy prior to initiation of study treatment
- Poor peripheral venous access
- Prior allogeneic stem cell or solid organ transplantation
- Concurrent participation in another therapeutic clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (68)
Anhui Provincial Hospital
Anhui, 230001, China
Anyang Tumor Hosptial
Anyang, 455000, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Luhe Hospital Capital Medical University
Beijing, China
the First Hospital of Jilin University
Changchun, 130021, China
Jilin Cancer Hospital
Changchun, 132013, China
Hunan Cancer Hospital
Changsha, 410013, China
Affiliated Hospital of Chengde Medical University
Chengde, 067020, China
Sichuan Provincial Cancer Hospital
Chengdu, 610041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Chongqing Sanxia Central Hospital
Chongqing, 404000, China
The First People's Hospital of Foshan
Foshan, 510000, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Fujian Provincial Hospital
Fuzhou, China
Southern Medical University Nanfang Hospital
Guangdong Province Guangzhou City, 510515, China
Zhejiang Cancer Hospital
Hangzhou, 310022, China
Harbin Medical University Cancer Hospital
Harbin, 150081, China
Anhui Province Cancer Hospital
Hefei, 12345, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, 230601, China
Huai'an First People's Hospital
Huai'an, China
The Second People's Hospital of Huai'an
Huai'an, China
Affiliated Hopsital of Jining Medical University
Jining, China
Gansu Province People Hospital
Lanzhou, 730000, China
The First People's Hospital of Lian Yun Gang
Lianyungang, 222002, China
Linyishi Cancer Hospital
Linyi, 276034, China
The First Affiliated Hospital to Henan University of Science and Technology
Luoyang, 471003, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, 210029, China
Jiangsu Cancer Hospital
Nanjing, 211100, China
Nan Tong Tumor Hospital
Nantong, 226361, China
Shanghai Chest Hospital
Shanghai, 200000, China
Zhongshan Hospital Fudan University
Shanghai, 200032, China
Fudan University Shanghai Cancer Center
Shanghai, 200120, China
Cancer Hospital of Shantou University Medical College
Shantou, 515041, China
Liaoning Provincial Cancer Hospital
Shengyang, 110042, China
Suining Central Hospital
Suining, 629000, China
Tianjin Cancer Hospital
Tianjin, 300060, China
Weifang People's Hospital
Weifang, China
Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, 430022, China
Hubei Cancer Hospital
Wuhan, 430079, China
Affiliated Hospital of Jiangnan University(Wuxi Fourth People's Hospital )
Wuxi, 214122, China
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038, China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
Xi'an, 710061, China
The First Affiliated Hospital of Xiamen University
Xiamen, 361003, China
Zhongshan Hospital Xiamen University
Xiamen, 361004, China
Xiangyang Central Hospital
Xiangyang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China
Xuzhou Central Hospital
Xuzhou, China
Northern Jangsu People's Hospital
Yangzhou, 225001, China
Henan Cancer Hospital
Zhengzhou, 450008, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, 450052, China
Queen Mary Hospital
Hong Kong, Hong Kong
Prince of Wales Hosp
Shatin, Hong Kong
Kyungpook National University Chilgok Hospital
Daegu, 41404, South Korea
National Cancer Center
Goyang-si, 10408, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13605, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
Chang Gung Medical Foundation - Kaohsiung
Kaohisung, Taiwan
National Cheng Kung University Hospital
Tainan, 00704, Taiwan
Taipei Veterans General Hospital
Taipei, 112201, Taiwan
National Taiwan University Hospital
Zhongzheng Dist., 10048, Taiwan
Chulalongkorn Hospital
Bangkok, 10330, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Ramathibodi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital
Bangkok, 10700, Thailand
Songklanagarind Hospital
Songkhla, 90110, Thailand
Related Publications (2)
Sun JM, Chao Y, Kim SB, Rha SY, Evans TRJ, Strickland AH, Wainberg Z, Chau I, Pelles-Avraham S, Ajani J, Malhotra R, Liu Q, Li S, Cha E, Kalaitzidou M, Huang X, Allen S, Hsu CH. First-line tiragolumab plus atezolizumab and chemotherapy in patients with previously untreated, locally advanced unresectable or metastatic oesophageal cancer (MORPHEUS-EC): a randomised, open-label, phase 1b/2 trial. Lancet Oncol. 2026 Jan;27(1):90-102. doi: 10.1016/S1470-2045(25)00402-4.
PMID: 41449151DERIVEDHsu CH, Lu Z, Gao S, Wang J, Sun JM, Liu T, Fan Q, Cai J, Ge F, Li S, Zhang L, Cha E, Allen S, Shen L. Tiragolumab plus atezolizumab and chemotherapy as first-line treatment for patients with unresectable oesophageal squamous cell carcinoma (SKYSCRAPER-08): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 Jan;27(1):103-115. doi: 10.1016/S1470-2045(25)00401-2.
PMID: 41449142DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 3, 2020
First Posted
September 7, 2020
Study Start
October 30, 2020
Primary Completion
February 13, 2023
Study Completion
August 28, 2025
Last Updated
April 9, 2026
Results First Posted
April 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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