A Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Participants With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck (SKYSCRAPER-09)
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ClinicalTrials.gov Identifier: NCT04665843 |
Recruitment Status :
Active, not recruiting
First Posted : December 14, 2020
Last Update Posted : December 12, 2022
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Condition or disease | Intervention/treatment | Phase |
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Squamous Cell Carcinoma of Head and Neck | Drug: Atezolizumab Drug: Tiragolumab Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Randomized, Double Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients With Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck |
Actual Study Start Date : | March 2, 2021 |
Estimated Primary Completion Date : | May 1, 2023 |
Estimated Study Completion Date : | October 2, 2024 |

Arm | Intervention/treatment |
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Experimental: Atezolizumab + Tiragolumab
Participants will receive atezolizumab followed by tiragolumab every three weeks (Q3W) on Day 1 of each 21-day cycle.
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Drug: Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Other Name: Tecentriq; RO5541267 Drug: Tiragolumab Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
Other Name: RO7092284 |
Placebo Comparator: Atezolizumab + Placebo
Participants will receive atezolizumab followed by placebo Q3W on Day 1 of each 21-day cycle.
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Drug: Atezolizumab
Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
Other Name: Tecentriq; RO5541267 Drug: Placebo Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle. |
- Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 43 months ]
- Duration of Response (DOR) [ Time Frame: Up to approximately 43 months ]
- Progression-Free Survival (PFS) [ Time Frame: Up to approximately 43 months ]
- Overall Survival (OS) [ Time Frame: Up to approximately 43 months ]
- Progression-Free Survival Rate at 6 Months [ Time Frame: Month 6 ]
- Overall Survival Rate at 6 Months and 12 Months [ Time Frame: Month 6, Month 12 ]
- Time to Confirmed Deterioration (TTCD) in Patient-Reported Physical Functioning [ Time Frame: Up to approximately 43 months ]
- Percentage of Participants With Adverse Events (AEs) [ Time Frame: Up to approximately 43 months ]
- Minimum Serum Concentration (Cmin) of Atezolizumab [ Time Frame: Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months ]
- Maximum Serum Concentration (Cmax) of Atezolizumab [ Time Frame: Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months ]
- Cmin of Tiragolumab [ Time Frame: Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months ]
- Cmax of Tiragolumab [ Time Frame: Predose and 30 minutes postdose on Day 1 of Cycle 1 (each cycle is 21 days), predose on Day 1 of Cycles 2, 3, 4, 8, 12, 16 and at treatment discontinuation visit up to approximately 43 months ]
- Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab [ Time Frame: From baseline up to approximately 43 months ]
- Number of Participants With ADAs to Tiragolumab [ Time Frame: From baseline up to approximately 43 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies
- Known results from human papillomavirus (HPV) status test for oropharyngeal carcinoma
- No prior systemic therapy for metastatic and/or recurrent SCCHN
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Tumor PD-L1 expression as determined by PD-L1 immunohistochemistry assay
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy >=12 weeks
Key Exclusion Criteria:
- Disease suitable for local therapy with curative intent
- Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN
- Rapidly progressing disease in the opinion of the treating investigator
- Grade >=2 unresolved toxicity related to surgery or other prior therapies
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- History of leptomeningeal disease
- 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 additional malignancy other than SCCHN within 5 years prior to randomization
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-TIGIT, anti-PD-L1, and anti-PD-1 therapeutic antibodies
- Treatment with systemic immunostimulatory agents or systemic immunosuppressive medication
- Pregnancy or breastfeeding

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665843

Study Director: | Clinical Trials | Hoffmann-La Roche |
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT04665843 |
Other Study ID Numbers: |
BO42533 2020-002852-19 ( EudraCT Number ) |
First Posted: | December 14, 2020 Key Record Dates |
Last Update Posted: | December 12, 2022 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm). |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms by Site Atezolizumab Antineoplastic Agents |