Clinical Trials List
Protocol NumberBO42533
NCT Number(ClinicalTrials.gov Identfier)NCT04665843
Active
2021-01-01 - 2025-12-31
Phase II
Not yet recruiting3
ICD-10C76.0
Malignant neoplasm of head, face and neck
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9195.0
Malignant neoplasm of other and ill-defined sites of head, face and neck
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
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Trial Applicant
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Sponsor
Hoffmann-La Roche
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Mu-Hsin Chang Division of Hematology & Oncology
- Tien-Hua Chen Division of Hematology & Oncology
- 陳盛裕 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ming-Yu Lien Division of Hematology & Oncology
- Yu-Min Liao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- HUAI-CHENG HUANG Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- RUEY-LONG HONG Division of Hematology & Oncology
- 張端瑩 Division of Hematology & Oncology
- 廖斌志 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Recurrent/Metastatic PD-L1 Positive Squamous Cell Carcinoma of the Head and Neck
Objectives
The primary objective of this study is to evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo as first-line (1L) treatment in recurrent/metastatic PD-L1-positive squamous cell carcinoma of the head and neck (SCCHN) on the basis of confirmed objective response rate. In addition, safety, pharmacokinetics, immunogenicity of atezolizumab and tiragolumab will be evaluated.
Test Drug
Atezolizumab
Tiragolumab
Tiragolumab
Active Ingredient
Atezolizumab
Tiragolumab
Tiragolumab
Dosage Form
IVT
IVT
IVT
Dosage
600mg/ml
60mg/ml
60mg/ml
Endpoints
Primary Outcome Measures :
Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 43 months ]
Secondary Outcome Measures :
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 ]
Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 43 months ]
Secondary Outcome Measures :
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 ]
Inclution Criteria
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
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
Exclusion Criteria
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
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
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
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
The Estimated Number of Participants
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Taiwan
24 participants
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Global
120 participants
